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

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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:
Collaborator:
Delta Dental Fund of Michigan
Information provided by (Responsible Party):
Geoffrey E. Gerstner, University of Michigan

Brief Summary:

Clinical trials of bite splint use and night time tooth grinding have not been performed. Consequently, there are no definitive outcome measures or efficacy standards that can be applied to large clinical trials. The present preliminary trial will determine what objective measures can be used to evaluate efficacy. The outcome variables will fall into four categories: (1) fabrication efficacy, (2) compliance, (3) functional efficacy, and (4) user satisfaction. The immediate goals will: (1) focus on the over-the counter SOVA night guard, (2) conduct tests under controlled clinical conditions using the 'gold standard', the acrylic 'bite splint' or 'orthotic', hereafter called the "Michigan bite splint", to compare the performance and efficacy of the SOVA night guard. Subsequent studies will be able to use the outcome variables identified in this study for broader clinical trials.

Specific Aim 1. To compare the SOVA night guard to the custom-acrylic Michigan bite splint in clinical laboratory conditions. Hypothesis: There will be no significant differences between the devices in terms of fabrication efficacy, functional efficacy or user satisfaction.

Specific Aim 2. To compare the SOVA night guard to the custom-acrylic Michigan bite splint under ecologically relevant conditions, i.e., the home environment. Hypothesis: There will be no significant differences between the devices in terms of compliance or functional efficacy.


Condition or disease Intervention/treatment Phase
Sleep Bruxism Tooth Wear Device: SOVA Bite Splint Device: Michigan Bite Splint Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Preliminary Phase IV Trial Comparing the SOVA Night Guard With the Clinical Standard Acrylic Orthotic
Study Start Date : November 2015
Actual Primary Completion Date : May 10, 2017
Actual Study Completion Date : May 10, 2017

Arm Intervention/treatment
Experimental: SOVA bite splint
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 3 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of three months.
Device: SOVA Bite Splint
Over-the-counter thermoplastic bite splint blank, heated, molded to fit.

Active Comparator: Michigan Bite Splint
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 3 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of three months.
Device: Michigan Bite Splint
Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit




Primary Outcome Measures :
  1. Total Number of Nights of Splint Wear for Four Months Per Subject. [ Time Frame: 4 months ]
    Count of the total number of entire nights that subjects wore the splint provided to them in the study.


Secondary Outcome Measures :
  1. Number of Bruxing Events Per Hour Sleep Per Night. [ Time Frame: 4 months ]
    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.

  2. Splint Material Loss / 4 Months. [ Time Frame: 4 months ]
    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.

  3. Compliance -- Appliance Removal at Night [ Time Frame: 4 months ]
    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.

  4. Compliance -- Use of Alternative Devices [ Time Frame: 4 months ]
    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.

  5. Functional Efficacy -- Tooth Wear [ Time Frame: 4 months ]
    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.

  6. Functional Efficacy -- Alteration of Bruxism Habit, Self Report of Reduced Bruxism [ Time Frame: 4 months ]
    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.

  7. Functional Efficacy -- Alteration of Bruxism Habit, Self-Report of Muscle Relaxation [ Time Frame: 4 months ]
    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.

  8. User Satisfaction -- Ease of Fabrication [ Time Frame: On day of delivery ]
    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.

  9. User Satisfaction -- Ease of Instructions [ Time Frame: On day of delivery ]
    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.

  10. User Satisfaction -- Self-Report of Splint Fit [ Time Frame: 4 months ]
    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.

  11. Fabrication Efficacy -- Estimated Bite Forces During Stability Testing [ Time Frame: 4 months ]
    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.

  12. Fabrication Efficacy -- Retention Trials Week 1 [ Time Frame: 1 week ]
    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.

  13. Fabrication Efficacy -- Retention Trials, Month 4 [ Time Frame: 4 months ]
    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.

  14. Fabrication Efficacy -- Tissue Adaptation, Palatal Rim. Number of Participants With Poor Adaptation [ Time Frame: Day of delivery ]
    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.

  15. Fabrication Efficacy -- Tissue Adaptation, Facial Rim. Number of Participants With Poor Adaptation [ Time Frame: Day of Delivery ]
    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.

  16. Fabrication Efficacy -- Tissue Adaptation, Number of Subjects Whose Splints Had Excessive Material [ Time Frame: Day of Delivery ]
    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.

  17. Fabrication Efficacy -- Tissue Adaptation, Tightness. Number of Participants Reporting Excessive Tightness [ Time Frame: Day of Delivery ]
    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.

  18. Fabrication Efficacy -- Oral Health Plaque Index [ Time Frame: 1 week and 4 months ]
    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.

  19. Fabrication Efficacy -- Oral Health Modified Gingival Index [ Time Frame: 1 week and 4 months ]
    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.

  20. Stability -- Splint Movement During Jaw Movement Tasks [ Time Frame: 4 months ]
    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.

  21. Stability -- Number of Splints Dislodged by Clenching [ Time Frame: 4 months ]
    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.

  22. Stability -- Number of Splints Dislodged by Grinding [ Time Frame: 4 Months ]
    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.

  23. Stability -- Number of Splints Dislodged During Border Movement Trials [ Time Frame: 4 months ]
    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.

  24. Stability -- Number of Splints Dislodged by Tapping [ Time Frame: 4 months ]
    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.

  25. Stability -- Number of Splints Dislodged During Maximum Openings [ Time Frame: 4 Months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult
  • Tooth wear
  • Night time grinding and clenching noises
  • Full dentition sans 3rd molars
  • Ability to follow instructions
  • Ability to report to the clinical laboratory at appointed times over the course of the study.

Exclusion Criteria

  • Decayed, missing teeth
  • Cardiovascular disease
  • Sleep apnea, sleep disorders, movement disorders
  • Active orthodontics
  • Periodontal disease
  • Partial or full dentures
  • Medications with movement disorders as side effects

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02340663


Locations
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United States, Michigan
University of Michigan School of Dentistry
Ann Arbor, Michigan, United States, 48109-1078
Sponsors and Collaborators
University of Michigan
Delta Dental Fund of Michigan
Investigators
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Principal Investigator: Geoffrey Gerstner, DDS, MS, PhD University of Michigan
  Study Documents (Full-Text)

Documents provided by Geoffrey E. Gerstner, University of Michigan:

Publications:

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Responsible Party: Geoffrey E. Gerstner, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT02340663     History of Changes
Other Study ID Numbers: HUM00085489
First Posted: January 16, 2015    Key Record Dates
Results First Posted: July 9, 2018
Last Update Posted: July 9, 2018
Last Verified: June 2018
Keywords provided by Geoffrey E. Gerstner, University of Michigan:
dental orthotic
bite splint
oral parafunction
clenching
grinding
Additional relevant MeSH terms:
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Bruxism
Sleep Bruxism
Tooth Wear
Tooth Diseases
Stomatognathic Diseases
Parasomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders