Nocturnal Mouth Guards, SOVA vs. Standard Acrylic Orthotic; Phase IV (SISU-SOVA)

• ClinicalTrials.gov Identifier: NCT02340663
• Recruitment Status: Completed
• First Posted: January 16, 2015
• Results First Posted: July 9, 2018
• Last Update Posted: July 9, 2018
• Sponsor: University of Michigan
• Collaborator: Delta Dental Fund of Michigan
• Information provided by (Responsible Party): Geoffrey E. Gerstner, University of Michigan

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Supportive Care
• Conditions: Sleep Bruxism; Tooth Wear
• Interventions: Device: SOVA Bite Splint; Device: Michigan Bite Splint
• Enrollment: 67

Participant Flow

Recruitment Details	104 individuals screened, 81 met criteria
Pre-assignment Details	14 individuals dropped out prior to group assignment during consent process due to time/scheduling issues

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description	SOVA Bite splint: Over-the-counter, heat-and-mold bite splint. Investigators evaluate subject self-fabrication, and evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of three months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	Michigan bite splint: Gold standard, custom acrylic bite splint made for subjects. Investigators evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of three months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Period Title: Overall Study
Started	35	32
Clinical Exam, Impressions	35	32
Splint Delivery, Assessments	33	31
1 Week Follow-up, Assessments	33	31
4 Month Follow-up, Assessments	30	31
Completed	30	31
Not Completed	5	1
Reason Not Completed
Lost to Follow-up	1	0
Protocol Violation	1	0
Withdrawal by Subject	3	1

Baseline Characteristics

Arm/Group Title		SOVA Bite Splint	Michigan Bite Splint	Total
Arm/Group Description		SOVA Bite splint: Over-the-counter, heat-and-mold bite splint. Investigators evaluate subject self-fabrication, and evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of three months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	Michigan bite splint: Gold standard, custom acrylic bite splint made for subjects. Investigators evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of three months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit	Total of all reporting groups
Overall Number of Baseline Participants		35	32	67
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	35 participants	32 participants	67 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	35 100.0%	32 100.0%	67 100.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	35 participants	32 participants	67 participants
		25.5 (3.33)	25.4 (3.83)	25.5 (3.55)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	35 participants	32 participants	67 participants
	Female	19 54.3%	15 46.9%	34 50.7%
	Male	16 45.7%	17 53.1%	33 49.3%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	35 participants	32 participants	67 participants
	Hispanic or Latino	3 8.6%	1 3.1%	4 6.0%
	Not Hispanic or Latino	31 88.6%	30 93.8%	61 91.0%
	Unknown or Not Reported	1 2.9%	1 3.1%	2 3.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	35 participants	32 participants	67 participants
	American Indian or Alaska Native	0 0.0%	1 3.1%	1 1.5%
	Asian	7 20.0%	5 15.6%	12 17.9%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	2 5.7%	2 6.3%	4 6.0%
	White	26 74.3%	23 71.9%	49 73.1%
	More than one race	0 0.0%	1 3.1%	1 1.5%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants
United States	Number Analyzed	35 participants	32 participants	67 participants
		35 100.0%	32 100.0%	67 100.0%
Bruxing Self-report [1]; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	35 participants	32 participants	67 participants
< 1 night / month		1 2.9%	0 0.0%	1 1.5%
1-3 nights / month		6 17.1%	4 12.5%	10 14.9%
1 -3 nights / week		15 42.9%	14 43.8%	29 43.3%
4 - 7 nights / week		13 37.1%	14 43.8%	27 40.3%
		[1] Measure Description: 4-point scale reflecting frequency of nights bruxing per week or per month

Outcome Measures

1. Primary Outcome

Title	Total Number of Nights of Splint Wear for Four Months Per Subject.
Description	Count of the total number of entire nights that subjects wore the splint provided to them in the study.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description:	SOVA Bite splint: Over-the-counter, heat-and-mold bite splint. Investigators evaluate subject self-fabrication, and evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	Michigan bite splint: Gold standard, custom acrylic bite splint made for subjects. Investigators evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Overall Number of Participants Analyzed	30	31
Mean (Standard Deviation); Unit of Measure: nights
	93.6 (31.62)	98.7 (41.13)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOVA Bite Splint, Michigan Bite Splint
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.23
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	[Not Specified]

2. Secondary Outcome

Title	Number of Bruxing Events Per Hour Sleep Per Night.
Description	Polysomnographic monitors were used to evaluate masticatory muscle activity during sleep. Activity of jaw closing muscles found in the cheeks (masseter muscles) occur in bursts, where a burst is taken as evidence for a jaw clench. The total number of bursts recorded during the night was tabulated and then divided by the total hours of sleep. Means presented are based on data gathered on night 122 (4 months of splint wear) and compared with ANOVA.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

Polysomnographic data were not available from 5 SOVA and 3 Michigan splint subjects due to data corruption. Corruption typically occurs when a subject either removes the device or an electrode while sleeping, or the recorded data are too noisy to analyze due to electronic interference while the subject is asleep.

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description:	SOVA Bite splint: Over-the-counter, heat-and-mold bite splint. Investigators evaluate subject self-fabrication, and evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	Michigan bite splint: Gold standard, custom acrylic bite splint made for subjects. Investigators evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Overall Number of Participants Analyzed	25	28
Mean (Standard Deviation); Unit of Measure: muscle bursts / hour
	52.9 (27.15)	41.5 (25.11)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOVA Bite Splint, Michigan Bite Splint
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.045
	Comments	[Not Specified]
	Method	ANOVA
	Comments	[Not Specified]

3. Secondary Outcome

Title	Splint Material Loss / 4 Months.
Description	Splint wear measured in millimeters. The number is negative to reflect the amount lost, e.g., -0.1 = a tenth of a millimeter lost. High-resolution, computer-scanned models of the splint on the delivery date were combined with high-resolution, computer-scanned models of the same splint after 4 months of wear. Sites where teeth contacted the splints were identified, and material loss in these areas was quantified using a computer program designed to quantify differences between two computer models. The measurement represents the difference between the two models, defined by a mean value sampled from a standard-sized area, which was set to be about the size of a tooth cusp (~ 3 millimeters in diameter). Group means were compared with t-tests.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

Three SOVA subjects and 1 Michigan subject were not included in the analysis, because the scanned models could not be successfully aligned. This was likely due to a warpage of the impressions taken, warpage in the stone models that were scanned, or error in the model scanning process.

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description:	SOVA Bite splint: Over-the-counter, heat-and-mold bite splint. Investigators evaluate subject self-fabrication, and evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	Michigan bite splint: Gold standard, custom acrylic bite splint made for subjects. Investigators evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Overall Number of Participants Analyzed	27	30
Mean (Standard Deviation); Unit of Measure: millimeters
	-0.20 (0.170)	-0.17 (0.234)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOVA Bite Splint, Michigan Bite Splint
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.665
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	[Not Specified]

4. Secondary Outcome

Title	Compliance -- Appliance Removal at Night
Description	Responses to the question, "I frequently remove the splint during the night" with a 5-point Likert scale, anchored on the left with "Strongly Disagree" (receiving a score of 0) and on the right with "Strongly Agree" (receiving a score of 4). Question was filled out at the end of 4 months of splint wear.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description:	SOVA Bite splint: Over-the-counter, heat-and-mold bite splint. Investigators evaluate subject self-fabrication, and evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	Michigan bite splint: Gold standard, custom acrylic bite splint made for subjects. Investigators evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Overall Number of Participants Analyzed	30	31
Mean (Standard Deviation); Unit of Measure: Units on a scale
	1.2 (1.40)	0.8 (1.19)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOVA Bite Splint, Michigan Bite Splint
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.249
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

5. Secondary Outcome

Title	Compliance -- Use of Alternative Devices
Description	Responses to the question, "I use an additional splint" with a 5-point Likert scale, anchored on the left with "Strongly Disagree" (receiving a score of 0) and on the right with "Strongly Agree" (receiving a score of 4). Question was filled out at the end of 4 months of splint wear.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description:	SOVA Bite splint: Over-the-counter, heat-and-mold bite splint. Investigators evaluate subject self-fabrication, and evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	Michigan bite splint: Gold standard, custom acrylic bite splint made for subjects. Investigators evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Overall Number of Participants Analyzed	30	31
Mean (Standard Deviation); Unit of Measure: Units on a scale
	0.6 (1.30)	0.5 (1.06)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOVA Bite Splint, Michigan Bite Splint
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.626
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

6. Secondary Outcome

Title	Functional Efficacy -- Tooth Wear
Description	Tooth wear measured in millimeters. The number is negative to reflect the amount lost, e.g., -0.1 = a tenth of a millimeter lost. High-resolution, computer-scanned models of the teeth in the lower jaw on the delivery data were combined with high-resolution, computer-scanned models of the same teeth and jaw after 4 months of splint wear. Sites where teeth showed cratering due to dentin exposure were targeted to make these measurements. Changes in these areas was quantified using a computer program designed to quantify differences between two computer models. The measurement represents the difference between the two models, defined by a mean value sampled from a standard-sized area, which was set to be about the size of dentin exposure areas (~ 1 millimeter in diameter). Group means were compared with t-tests.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

Mandibular models were not available for two SOVA patients.

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description:	SOVA Bite splint: Over-the-counter, heat-and-mold bite splint. Investigators evaluate subject self-fabrication, and evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	Michigan bite splint: Gold standard, custom acrylic bite splint made for subjects. Investigators evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Overall Number of Participants Analyzed	28	31
Mean (Standard Deviation); Unit of Measure: millimeters
	-.060 (0.013)	-.053 (0.013)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOVA Bite Splint, Michigan Bite Splint
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.695
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	[Not Specified]

7. Secondary Outcome

Title	Functional Efficacy -- Alteration of Bruxism Habit, Self Report of Reduced Bruxism
Description	Responses to the question, "The splint helps my bruxism." with a 5-point Likert scale, anchored on the left with "Strongly Disagree" (receiving a score of 0) and on the right with "Strongly Agree" (receiving a score of 4). Question was filled out at the end of 4 months of splint wear.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

Question not answered by one SOVA participant.

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description:	SOVA Bite splint: Over-the-counter, heat-and-mold bite splint. Investigators evaluate subject self-fabrication, and evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	Michigan bite splint: Gold standard, custom acrylic bite splint made for subjects. Investigators evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Overall Number of Participants Analyzed	29	31
Mean (Standard Deviation); Unit of Measure: Units on a scale
	2.7 (1.00)	3.0 (0.87)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOVA Bite Splint, Michigan Bite Splint
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.255
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

8. Secondary Outcome

Title	Functional Efficacy -- Alteration of Bruxism Habit, Self-Report of Muscle Relaxation
Description	Responses to the question, "The splint relaxes my jaw muscles." with a 5-point Likert scale, anchored on the left with "Strongly Disagree" (receiving a score of 0) and on the right with "Strongly Agree" (receiving a score of 4). Question was filled out at the end of 4 months of splint wear.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description:	SOVA Bite splint: Over-the-counter, heat-and-mold bite splint. Investigators evaluate subject self-fabrication, and evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	Michigan bite splint: Gold standard, custom acrylic bite splint made for subjects. Investigators evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Overall Number of Participants Analyzed	30	31
Mean (Standard Deviation); Unit of Measure: Units on a scale
	1.9 (0.94)	2.5 (1.09)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOVA Bite Splint, Michigan Bite Splint
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	.049
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

9. Secondary Outcome

Title	User Satisfaction -- Ease of Fabrication
Description	Responses to the question, "The splint was easy to fabricate" with a 5-point Likert scale, anchored on the left with "Strongly Disagree" (receiving a score of 0) and on the right with "Strongly Agree" (receiving a score of 4). Question was filled out at the end of the appointment during which time the splints were made by participants.
Time Frame	On day of delivery

Outcome Measure Data

Analysis Population Description

One SOVA bite splint participant did not respond. Participants with the Michigan bite splint did not fabricate their splints; hence, this question is irrelevant to them.

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description:	SOVA Bite splint: Over-the-counter, heat-and-mold bite splint. Investigators evaluate subject self-fabrication, and evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	Michigan bite splint: Gold standard, custom acrylic bite splint made for subjects. Investigators evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Overall Number of Participants Analyzed	29	0
Measure Type: Count of Participants; Unit of Measure: Participants
Strongly disagree	1 3.4%
Somewhat disagree	3 10.3%
Neither agree nor disagree	1 3.4%
Somewhat agree	13 44.8%
Strongly agree	11 37.9%

10. Secondary Outcome

Title	User Satisfaction -- Ease of Instructions
Description	Responses to the question, "The instructions were easy to follow" with a 5-point Likert scale, anchored on the left with "Strongly Disagree" (receiving a score of 0) and on the right with "Strongly Agree" (receiving a score of 4). Question was filled out at the end of the appointment during which time the splints were made by participants.
Time Frame	On day of delivery

Outcome Measure Data

Analysis Population Description

One SOVA bite splint participant did not respond to this question. Michigan bite splint participants did not fabricate their splints; hence, this question was irrelevant for them.

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description:	SOVA Bite splint: Over-the-counter, heat-and-mold bite splint. Investigators evaluate subject self-fabrication, and evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	Michigan bite splint: Gold standard, custom acrylic bite splint made for subjects. Investigators evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Overall Number of Participants Analyzed	29	0
Measure Type: Count of Participants; Unit of Measure: Participants
Strongly disagree	0 0.0%
Somewhat disagree	1 3.4%
Neither agree nor disagree	2 6.9%
Somewhat agree	16 55.2%
Strongly agree	10 34.5%

11. Secondary Outcome

Title	User Satisfaction -- Self-Report of Splint Fit
Description	Responses to the question, "The splint fits well" with a 5-point Likert scale, anchored on the left with "Strongly Disagree" (receiving a score of 0) and on the right with "Strongly Agree" (receiving a score of 4). Question was filled out during the final appointment.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description:	SOVA Bite splint: Over-the-counter, heat-and-mold bite splint. Investigators evaluate subject self-fabrication, and evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	Michigan bite splint: Gold standard, custom acrylic bite splint made for subjects. Investigators evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Overall Number of Participants Analyzed	30	31
Mean (Standard Deviation); Unit of Measure: Units on a scale
	3.1 (1.23)	3.3 (0.83)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOVA Bite Splint, Michigan Bite Splint
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.750
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

12. Secondary Outcome

Title	Fabrication Efficacy -- Estimated Bite Forces During Stability Testing
Description	Estimated bite forces in kilograms associated with performing each of the following tasks: moving the jaw in extreme positions with pressure against the splint (Border), clenching (Clench), grinding side to side (Grind Lateral), grinding front to back (Grind Protrusive), tapping hard on splint (Tap). Overall means for each treatment group (SOVA and Michigan splints) are also reported.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description:	SOVA Bite splint: Over-the-counter, heat-and-mold bite splint. Investigators evaluate subject self-fabrication, and evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	Michigan bite splint: Gold standard, custom acrylic bite splint made for subjects. Investigators evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Overall Number of Participants Analyzed	30	31
Mean (Standard Deviation); Unit of Measure: kilograms
Group Means	28.4 (1.13)	16.7 (1.09)
Border	24.4 (1.14)	11.7 (1.11)
Clench	49.7 (1.14)	35.5 (1.11)
Grind Lateral	17.7 (1.14)	10.4 (1.10)
Grind Protrusive	25.4 (1.15)	12.3 (1.11)
Tap	34.1 (1.14)	24.4 (1.11)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOVA Bite Splint, Michigan Bite Splint
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.01
	Comments	The P-value given is the computed value
	Method	Mixed Models Analysis
	Comments	[Not Specified]

13. Secondary Outcome

Title	Fabrication Efficacy -- Retention Trials Week 1
Description	Number of times splint was dislodged while performing eight different movements, with each movement being performed five times (maximum number therefore = 40). Dislodgement meant that, after performing the movement, the splint either fell off the teeth completely or that biting down on the splint resulted in its being reseated on the teeth.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

Data not available for one SOVA participant.

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description:	SOVA Bite splint: Over-the-counter, heat-and-mold bite splint. Investigators evaluate subject self-fabrication, and evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	Michigan bite splint: Gold standard, custom acrylic bite splint made for subjects. Investigators evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Overall Number of Participants Analyzed	29	31
Mean (Standard Deviation); Unit of Measure: Occurrences
	1.1 (1.93)	0.6 (1.69)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOVA Bite Splint, Michigan Bite Splint
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.544
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

14. Secondary Outcome

Title	Fabrication Efficacy -- Retention Trials, Month 4
Description	Number of times splint was dislodged while performing eight different movements, with each movement being performed five times (maximum number therefore = 40). Dislodgement meant that, after performing the movement, the splint either fell off the teeth completely or that biting down on the splint resulted in its being reseated on the teeth.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

Data not available for one SOVA participant.

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description:	SOVA Bite splint: Over-the-counter, heat-and-mold bite splint. Investigators evaluate subject self-fabrication, and evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	Michigan bite splint: Gold standard, custom acrylic bite splint made for subjects. Investigators evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Overall Number of Participants Analyzed	29	31
Mean (Standard Deviation); Unit of Measure: Number of occurrences out of 40.
	1.7 (3.42)	0.6 (1.86)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOVA Bite Splint, Michigan Bite Splint
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.220
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

15. Secondary Outcome

Title	Fabrication Efficacy -- Tissue Adaptation, Palatal Rim. Number of Participants With Poor Adaptation
Description	Palate-side of splints was evaluated for contact with the palate. Splints that were > 1 mm from contact with palate, from molar to molar were graded as 1 (poor adaptation); splints in continuous contact or lacking contact < 1mm with palate, from molar to molar were graded as 0 (good adaptation). Number of participants with splints in each group with poor adaptation is reported.
Time Frame	Day of delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description:	SOVA Bite splint: Over-the-counter, heat-and-mold bite splint. Investigators evaluate subject self-fabrication, and evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	Michigan bite splint: Gold standard, custom acrylic bite splint made for subjects. Investigators evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Overall Number of Participants Analyzed	30	31
Measure Type: Count of Participants; Unit of Measure: Participants
	7 23.3%	2 6.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOVA Bite Splint, Michigan Bite Splint
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.081
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

16. Secondary Outcome

Title	Fabrication Efficacy -- Tissue Adaptation, Facial Rim. Number of Participants With Poor Adaptation
Description	Lip- and cheek-sides of splints were evaluated for contact with the premolar and molar teeth. Splints lacking contact (> 1 mm space between splint and teeth) were graded as 1 (poor adaptation); splints with < 1 mm space between splint and teeth, from molar to molar as 0 (good adaptation). Inter-proximal contacts Number of total participants with splints in each group with poor adaptation is reported.
Time Frame	Day of Delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description:	SOVA Bite splint: Over-the-counter, heat-and-mold bite splint. Investigators evaluate subject self-fabrication, and evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	Michigan bite splint: Gold standard, custom acrylic bite splint made for subjects. Investigators evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Overall Number of Participants Analyzed	30	31
Measure Type: Count of Participants; Unit of Measure: Participants
	4 13.3%	4 12.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOVA Bite Splint, Michigan Bite Splint
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	1.0
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

17. Secondary Outcome

Title	Fabrication Efficacy -- Tissue Adaptation, Number of Subjects Whose Splints Had Excessive Material
Description	Splint rims were evaluated for thickness. Splints requiring modification by the attending dentist to remove excess material were graded as 1 (poor adaptation); splints that did not require removal of excess material were graded as 0 (good adaptation). Number of participants in each group whose splint manifest poor adaptation is reported.
Time Frame	Day of Delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description:	SOVA Bite splint: Over-the-counter, heat-and-mold bite splint. Investigators evaluate subject self-fabrication, and evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	Michigan bite splint: Gold standard, custom acrylic bite splint made for subjects. Investigators evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Overall Number of Participants Analyzed	30	31
Measure Type: Count of Participants; Unit of Measure: Participants
	5 16.7%	4 12.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOVA Bite Splint, Michigan Bite Splint
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.731
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

18. Secondary Outcome

Title	Fabrication Efficacy -- Tissue Adaptation, Tightness. Number of Participants Reporting Excessive Tightness
Description	Splints were evaluated for sensation of tightness on the teeth. SOVA splints that were said to be too tight by the participants and that subsequently required intervention by the attending dentist to fix were graded as 1 (poor adaptation); Michigan splints that were said to be too tight by the participants and that required the attending dentist to spend > 15 minutes of the delivery appointment to fix were graded as 1 (poor adaptation); all splints not meeting these criteria were scored as 0 (good adaptation). Total participants in each group with poorly adapted splints is reported.
Time Frame	Day of Delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description:	SOVA Bite splint: Over-the-counter, heat-and-mold bite splint. Investigators evaluate subject self-fabrication, and evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	Michigan bite splint: Gold standard, custom acrylic bite splint made for subjects. Investigators evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Overall Number of Participants Analyzed	30	31
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%	3 9.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOVA Bite Splint, Michigan Bite Splint
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.238
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

19. Secondary Outcome

Title	Fabrication Efficacy -- Oral Health Plaque Index
Description	The Rustogi et al. Modification of the Navy Plaque Index method of scoring plaque was used. This involves dividing the cheek-facing (Buccal) and the tongue/palate-facing (Lingual) surfaces of each tooth into 9 regions and scoring whether disclosed plaque is present (1) or absent (0) in each of these 9 regions. The total number of regions with plaque was then tabulated as the proportion of total regions for four mouth areas, viz., the cheek sides of the upper teeth (Buccal Upper), the cheek sides of the lower teeth (Buccal Lower), the palate sides of the upper teeth (Lingual Upper) and the tongue sides of the lower teeth (Lingual Lower). Overall means for each treatment group (SOVA and Michigan splints) are also reported.
Time Frame	1 week and 4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description:	SOVA Bite splint: Over-the-counter, heat-and-mold bite splint. Investigators evaluate subject self-fabrication, and evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	Michigan bite splint: Gold standard, custom acrylic bite splint made for subjects. Investigators evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Overall Number of Participants Analyzed	30	31
Mean (Standard Deviation); Unit of Measure: proportion of total regions
Buccal Upper, Week 1	0.46 (0.187)	0.42 (0.165)
Buccal Upper, Month 4	0.46 (0.163)	0.38 (0.155)
Buccal Lower, Week 1	0.41 (0.187)	0.43 (0.147)
Buccal Lower, Month 4	0.37 (0.135)	0.39 (0.125)
Lingual Upper, Week 1	0.31 (0.173)	0.31 (0.174)
Lingual Upper, Month 4	0.29 (0.109)	0.28 (0.108)
Lingual Lower, Week 1	0.39 (0.127)	0.44 (0.169)
Lingual Lower, Month 4	0.39 (0.142)	0.41 (0.138)
Group Means	0.39 (0.019)	0.38 (0.019)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOVA Bite Splint, Michigan Bite Splint
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.952
	Comments	The P-value refers to the difference in group means, see "Group Means" row in the table.
	Method	ANOVA
	Comments	[Not Specified]

20. Secondary Outcome

Title	Fabrication Efficacy -- Oral Health Modified Gingival Index
Description	Gums or gingiva around each tooth is quantified for absence of inflammation (0), mild inflammation around part of the gingiva next to the tooth (1), mild inflammation involving all of the gingiva next to the tooth (2), moderate inflammation (3), or severe inflammation (4). Average scores are created for the cheek side of the upper teeth (Buccal Upper), palate side of upper teeth (Lingual Upper), cheek side of lower teeth (Buccal Lower) and tongue side of lower teeth (Lingual Lower). Mean and standard deviation scores for each of these regions and for week 1 and month 4 are shown as descriptive statistics; statistical results for the between-subject effects are reported. Overall means for each treatment group (SOVA and Michigan splints) are also reported.
Time Frame	1 week and 4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description:	SOVA Bite splint: Over-the-counter, heat-and-mold bite splint. Investigators evaluate subject self-fabrication, and evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	Michigan bite splint: Gold standard, custom acrylic bite splint made for subjects. Investigators evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Overall Number of Participants Analyzed	30	31
Mean (Standard Deviation); Unit of Measure: Units on a scale
Buccal Upper, Week 1	0.96 (0.628)	0.92 (0.673)
Buccal Upper, Month 4	1.02 (0.757)	1.00 (0.747)
Buccal Lower, Week 1	0.87 (0.542)	0.92 (0.643)
Buccal Lower, Month 4	0.99 (0.713)	0.95 (0.746)
Lingual Upper, Week 1	0.88 (0.610)	0.86 (0.67)
Lingual Upper, Month 4	0.95 (0.722)	0.91 (0.644)
Lingual Lower, Week 1	1.09 (0.679)	1.03 (0.696)
Lingual Lower, Month 4	1.08 (0.748)	0.98 (0.726)
Group Means	0.93 (0.04)	0.89 (0.039)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOVA Bite Splint, Michigan Bite Splint
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.53
	Comments	The P-value refers to the difference in group means, see "Group Means" row in the table.
	Method	ANOVA
	Comments	[Not Specified]

21. Secondary Outcome

Title	Stability -- Splint Movement During Jaw Movement Tasks
Description	Movement of each subject's splint on the teeth, due to rocking or dislodgement, measured in millimeters during five repetitions of the following five tasks: clenching, grinding, moving jaw to extreme positions on the splint, tapping, opening maximally. For control, movements of the splint while the jaw was in a rest position (teeth apart, jaw relaxed) were also measured. The maximum movement during the five repetitions of each task was calculated for each subject and used in statistical analyses.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

Data not available for one participant in the Michigan bite splint treatment group.

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description:	SOVA Bite splint: Over-the-counter, heat-and-mold bite splint. Investigators evaluate subject self-fabrication, and evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	Michigan bite splint: Gold standard, custom acrylic bite splint made for subjects. Investigators evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Overall Number of Participants Analyzed	30	30
Mean (Standard Deviation); Unit of Measure: millimeters
Clenching	0.72 (1.938)	0.71 (1.583)
Grinding	0.83 (1.660)	0.78 (0.697)
Border Movements	0.63 (1.238)	1.12 (1.331)
Tapping	0.33 (0.412)	0.30 (0.361)
Maximum Opening	1.16 (0.940)	1.60 (1.298)
Resting	0.16 (0.177)	0.22 (0.225)
Group Means	0.65 (1.257)	0.78 (1.143)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOVA Bite Splint, Michigan Bite Splint
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.292
	Comments	The P-value refers to the difference in group means, see "Group Means" row in the table.
	Method	Mixed Models Analysis
	Comments	[Not Specified]

22. Secondary Outcome

Title	Stability -- Number of Splints Dislodged by Clenching
Description	Count of the number of participants whose individual splints were dislodged at least once when participants clenched their teeth against the splint five times. Numbers are sorted into those that moved < 1 mm, those that moved between 1 - 2 mm, those that moved between 2 - 3 mm and those that moved > 6 mm during the performance of five repeats of clenching. Categories from 3 mm to 6 mm are not included, because no splints fell into this range of values.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

Data not available for one participant in the Michigan bite splint group

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description:	SOVA Bite splint: Over-the-counter, heat-and-mold bite splint. Investigators evaluate subject self-fabrication, and evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	Michigan bite splint: Gold standard, custom acrylic bite splint made for subjects. Investigators evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Overall Number of Participants Analyzed	30	30
Measure Type: Count of Participants; Unit of Measure: Participants
< 1 mm	26 86.7%	27 90.0%
1 - 2 mm	2 6.7%	1 3.3%
2 - 3 mm	1 3.3%	1 3.3%
> 6 mm	1 3.3%	1 3.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOVA Bite Splint, Michigan Bite Splint
	Comments	The P-value refers to the main effect of treatment group, i.e., differences between SOVA bite splints and Michigan bite splints.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.289
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

23. Secondary Outcome

Title	Stability -- Number of Splints Dislodged by Grinding
Description	Count of the number of participants whose individual splints were dislodged at least once when participants ground their teeth against the splint to the left (5 times), to the right (5 times, and front to back (5 times). Count is partitioned into those dislodged by < 1 mm, between 1 - 2 mm, between 2 - 3 mm, between 3 - 4 mm, and > 6 mm. Categories between 4 and 6 mm are not included, as no splints fell into this range.
Time Frame	4 Months

Outcome Measure Data

Analysis Population Description

Data not available for one participant in the Michigan bite splint group.

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description:	SOVA Bite splint: Over-the-counter, heat-and-mold bite splint. Investigators evaluate subject self-fabrication, and evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	Michigan bite splint: Gold standard, custom acrylic bite splint made for subjects. Investigators evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Overall Number of Participants Analyzed	30	30
Measure Type: Count of Participants; Unit of Measure: Participants
< 1 mm	26 86.7%	23 76.7%
1 - 2 mm	3 10.0%	4 13.3%
2 - 3 mm	0 0.0%	2 6.7%
3 - 4 mm	0 0.0%	1 3.3%
> 6 mm	1 3.3%	0 0.0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOVA Bite Splint, Michigan Bite Splint
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.287
	Comments	The P-value refers to the main effect of treatment group, i.e., differences between SOVA bite splints and Michigan bite splints.
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

24. Secondary Outcome

Title	Stability -- Number of Splints Dislodged During Border Movement Trials
Description	Count of the number of participants whose individual splints were dislodged at least once when participants performed grinding-like movements of the teeth against the splint in extreme positions. These extreme movements and positions were performed 5 times. Counts are partitioned into those dislodged > 1 mm, those dislodged between 1 - 2 mm, those dislodged 2 - 3 mm, those dislodged 3 - 4 mm, those dislodged 4 - 5 mm, those dislodged 5 - 6 mm and those dislodged > 6 mm.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

Data not available for one participant in the Michigan bite splint group.

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description:	SOVA Bite splint: Over-the-counter, heat-and-mold bite splint. Investigators evaluate subject self-fabrication, and evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	Michigan bite splint: Gold standard, custom acrylic bite splint made for subjects. Investigators evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Overall Number of Participants Analyzed	30	30
Measure Type: Count of Participants; Unit of Measure: Participants
< 1 mm	28 93.3%	20 66.7%
1 - 2 mm	0 0.0%	5 16.7%
2 - 3 mm	1 3.3%	2 6.7%
3 - 4 mm	0 0.0%	1 3.3%
4 - 5 mm	0 0.0%	1 3.3%
5 - 6 mm	0 0.0%	1 3.3%
> 6 mm	1 3.3%	0 0.0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOVA Bite Splint, Michigan Bite Splint
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.505
	Comments	The P-value refers to the main effect of treatment group, i.e., differences between SOVA bite splints and Michigan bite splints.
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

25. Secondary Outcome

Title	Stability -- Number of Splints Dislodged by Tapping
Description	Count of the number of participants whose individual splints were dislodged at least once when participants tapped their teeth on the splint 5 times. Counts are partitioned into the number dislodged < 1 mm, and those dislodged between 1 - 2 mm.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

Data not available from one participant in the Michigan bite splint group.

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description:	SOVA Bite splint: Over-the-counter, heat-and-mold bite splint. Investigators evaluate subject self-fabrication, and evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	Michigan bite splint: Gold standard, custom acrylic bite splint made for subjects. Investigators evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Overall Number of Participants Analyzed	30	30
Measure Type: Count of Participants; Unit of Measure: Participants
< 1 mm	28 93.3%	28 93.3%
1 - 2 mm	2 6.7%	2 6.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOVA Bite Splint, Michigan Bite Splint
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.643
	Comments	The P-value refers to the main effect of treatment group, i.e., differences between SOVA bite splints and Michigan bite splints.
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

26. Secondary Outcome

Title	Stability -- Number of Splints Dislodged During Maximum Openings
Description	Count of the number of participants whose individual splints were dislodged at least once when participants opened as wide as possible and then closed. The task was repeated five times. Counts are partitioned into the number dislodged < 1 mm, number dislodged between 1 - 2 mm, number dislodged between 2 - 3 mm, number dislodged between 3 - 4 mm and number dislodged between 4 - 5 mm.
Time Frame	4 Months

Outcome Measure Data

Analysis Population Description

Data not available for one participant in the Michigan bite splint group.

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description:	SOVA Bite splint: Over-the-counter, heat-and-mold bite splint. Investigators evaluate subject self-fabrication, and evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	Michigan bite splint: Gold standard, custom acrylic bite splint made for subjects. Investigators evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Overall Number of Participants Analyzed	30	30
Measure Type: Count of Participants; Unit of Measure: Participants
< 1 mm	18 60.0%	13 43.3%
1 - 2 mm	7 23.3%	8 26.7%
2 - 3 mm	2 6.7%	2 6.7%
3 - 4 mm	3 10.0%	5 16.7%
4 - 5 mm	0 0.0%	2 6.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOVA Bite Splint, Michigan Bite Splint
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.923
	Comments	The P-value refers to the main effect of treatment group, i.e., differences between SOVA bite splints and Michigan bite splints.
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

Adverse Events

Time Frame	4 months
Adverse Event Reporting Description	Each participant was followed for four months.
Arm/Group Title	SOVA Bite Splint		Michigan Bite Splint
Arm/Group Description	SOVA Bite splint: Over-the-counter, heat-and-mold bite splint. Investigators evaluate subject self-fabrication, and evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of three months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.		Michigan bite splint: Gold standard, custom acrylic bite splint made for subjects. Investigators evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of three months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
All-Cause Mortality
	SOVA Bite Splint		Michigan Bite Splint
	Affected / at Risk (%)		Affected / at Risk (%)
Total	0/35 (0.00%)		0/32 (0.00%)
Serious Adverse Events
	SOVA Bite Splint		Michigan Bite Splint
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0.00%)		0/32 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	1%
	SOVA Bite Splint		Michigan Bite Splint
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0.00%)		3/32 (9.38%)
General disorders
Tooth Chipped † 1	0/35 (0.00%)	0	1/32 (3.13%)	1
Metabolism and nutrition disorders
Mucosal Bleeding Spot † 1 [1]	0/35 (0.00%)	0	1/32 (3.13%)	1
Skin and subcutaneous tissue disorders
Skin Rash † 1 [2]	0/35 (0.00%)	0	1/32 (3.13%)	1
1 Term from vocabulary, MedDRA (Unspecified); † Indicates events were collected by systematic assessment; [1] Scrape by subject during splint insertion; [2] Tape sensitivity

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Dr. Geoffrey Gerstner
• Organization: University of Michigan
• Phone: 734-763-7717
• EMail: geger@umich.edu

Publications:

Cunha-Cruz J, Pashova H, Packard JD, Zhou L, Hilton TJ; for Northwest PRECEDENT. Tooth wear: prevalence and associated factors in general practice patients. Community Dent Oral Epidemiol. 2010 Jun;38(3):228-34. doi: 10.1111/j.1600-0528.2010.00537.x. Epub 2010 Mar 29.

Dworkin SF, LeResche L. Research diagnostic criteria for temporomandibular disorders: review, criteria, examinations and specifications, critique. J Craniomandib Disord. 1992 Fall;6(4):301-55. No abstract available.

Fricton J, Look JO, Wright E, Alencar FG Jr, Chen H, Lang M, Ouyang W, Velly AM. Systematic review and meta-analysis of randomized controlled trials evaluating intraoral orthopedic appliances for temporomandibular disorders. J Orofac Pain. 2010 Summer;24(3):237-54.

Gonzalez YM, Schiffman E, Gordon SM, Seago B, Truelove EL, Slade G, Ohrbach R. Development of a brief and effective temporomandibular disorder pain screening questionnaire: reliability and validity. J Am Dent Assoc. 2011 Oct;142(10):1183-91. doi: 10.14219/jada.archive.2011.0088.

Huynh N, Manzini C, Rompre PH, Lavigne GJ. Weighing the potential effectiveness of various treatments for sleep bruxism. J Can Dent Assoc. 2007 Oct;73(8):727-30.

Klasser GD, Greene CS, Lavigne GJ. Oral appliances and the management of sleep bruxism in adults: a century of clinical applications and search for mechanisms. Int J Prosthodont. 2010 Sep-Oct;23(5):453-62.

Lin AI, Braun T, McNamara JA Jr, Gerstner GE. Esthetic evaluation of dynamic smiles with attention to facial muscle activity. Am J Orthod Dentofacial Orthop. 2013 Jun;143(6):819-27. doi: 10.1016/j.ajodo.2013.01.017.

Maeda Y, Kumamoto D, Yagi K, Ikebe K. Effectiveness and fabrication of mouthguards. Dent Traumatol. 2009 Dec;25(6):556-564. doi: 10.1111/j.1600-9657.2009.00822.x. Epub 2009 Sep 24.

Monse B, Duijster D, Sheiham A, Grijalva-Eternod CS, van Palenstein Helderman W, Hobdell MH. The effects of extraction of pulpally involved primary teeth on weight, height and BMI in underweight Filipino children. A cluster randomized clinical trial. BMC Public Health. 2012 Aug 31;12:725. doi: 10.1186/1471-2458-12-725.

Ohrbach R, Larsson P, List T. The jaw functional limitation scale: development, reliability, and validity of 8-item and 20-item versions. J Orofac Pain. 2008 Summer;22(3):219-30.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gerstner G, Yao W, Siripurapu K, Aljanabi H, Decker A, Ludkin D, Sinacola R, Frimenko K, Callaghan K, Penoyer S, Tewksbury C. Over-the-counter bite splints: A randomized controlled trial of compliance and efficacy. Clin Exp Dent Res. 2020 Dec;6(6):626-641. doi: 10.1002/cre2.315. Epub 2020 Aug 10.

• Responsible Party: Geoffrey E. Gerstner, University of Michigan
• ClinicalTrials.gov Identifier: NCT02340663
• Other Study ID Numbers: HUM00085489
• First Submitted: January 13, 2015
• First Posted: January 16, 2015
• Results First Submitted: May 4, 2018
• Results First Posted: July 9, 2018
• Last Update Posted: July 9, 2018