Study to Compare Laser Assisted New Attachment Procedure (LANAP) to Traditional Treatments of Chronic Periodontitis (LANAP)

• ClinicalTrials.gov Identifier: NCT01282229
• Recruitment Status: Completed
• First Posted: January 24, 2011
• Results First Posted: October 14, 2015
• Last Update Posted: October 14, 2015
• Sponsor: Institute for Advanced Laser Dentistry
• Information provided by (Responsible Party): Institute for Advanced Laser Dentistry

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Chronic Periodontitis
• Intervention: Device: LANAP
• Enrollment: 59

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	All Participants
Arm/Group Description	Subjects will receive the Laser Assisted New Attachment Procedure (LANAP protocol) using the pulsed FR Nd:YAG laser, Scaling and Root Planing alone, Modified Widman Flap surgery, and Coronal Debridement alone each in one randomized quadrant of their mouth at Baseline.
Period Title: Overall Study
Started	59 [1]
Completed	57 [2]
Not Completed	2
Reason Not Completed
Protocol Violation	2
[1] 59 Participants contributed 236 quadrants (59*4); [2] 57 Participants contributed 228 quadrants (57*4)

Baseline Characteristics

Arm/Group Title		All Participants
Arm/Group Description		Subjects will receive the Laser Assisted New Attachment Procedure (LANAP protocol) using the pulsed FR Nd:YAG laser, Scaling and Root Planing alone, Modified Widman Flap surgery, and Coronal Debridement alone each in one randomized quadrant of their mouth at Baseline.
Overall Number of Baseline Participants		57
Baseline Analysis Population Description		Data are for number of quadrants
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	57 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	51 89.5%
	>=65 years	6 10.5%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	57 participants
	Female	27 47.4%
	Male	30 52.6%
Average Probing Depth (PD); Mean (Standard Deviation); Unit of measure: Mm	Number Analyzed	57 participants
PD = 5-6mm (LANAP Quadrant)		5.364 (.553)
PD = 5-6mm ( Modified Widman Flap)		5.358 (.569)
PD = 5-6mm (Scaling and Root Planing)		5.358 (.570)
PD = 5-6mm (Coronal Debridement)		5.382 (.554)
PD >= 7mm (LANAP Quadrant)		7.606 (.867)
PD >= 7mm (Modified Widman Flap)		7.562 (.901)
PD >= 7mm (Scaling and Root Planing)		7.657 (.967)
PD >= 7mm (Coronal Debridement)		7.672 (1.069)
Average Clinical Attachment Level (CAL); Mean (Standard Deviation); Unit of measure: Mm	Number Analyzed	57 participants
PD = 5-6mm (LANAP Quadrant)		5.431 (1.301)
PD = 5-6mm ( Modified Widman Flap)		5.440 (1.349)
PD = 5-6mm (Scaling and Root Planing)		5.364 (1.244)
PD = 5-6mm (Coronal Debridement)		5.468 (1.486)
PD >= 7mm (LANAP Quadrant)		7.453 (1.594)
PD >= 7mm (Modified Widman Flap)		7.737 (1.586)
PD >= 7mm (Scaling and Root Planing)		7.528 (1.751)
PD >= 7mm (Coronal Debridement)		7.681 (1.659)
Bleeding on Probing (BOP) [1]; Mean (Standard Deviation); Unit of measure: Percentage of pockets	Number Analyzed	57 participants
LANAP Quadrant		49.4 (31.4)
Modified Widman Flap		46.5 (31.2)
Scaling and Root Planing		48.2 (30.6)
Coronal Debridement		47.5 (31.2)
		[1] Measure Description: Percent of pockets within a quadrant that bled on probing by time and treatment
Gingival Index (GI) [1]; Mean (Standard Deviation); Unit of measure: Units on a scale	Number Analyzed	57 participants
LANAP Quadrant		2.48 (0.95)
Modified Widman Flap		2.42 (0.95)
Scaling and Root Planing		2.44 (0.96)
Coronal Debridement		2.43 (0.95)
		[1] Measure Description: Modified Gingival Index of Lobene et al (1986). Inflammation rated 0 (none) to 4 (severe).

Outcome Measures

1. Primary Outcome

Title	Gain in Clinical Attachment Level of Periodontal Tissues
Description	Periodontitis causes loss of attachment of the tooth root to the surrounding bone. Change in Clinical Attachment Level (CAL) estimates the number of mm's of reattachment gained as a result of the treatment.
Time Frame	Baseline, 6, 12 months

Outcome Measure Data

Analysis Population Description

5-6 mm baseline PD partition had a different sample size than the 7+mm partition.

Arm/Group Title	LANAP Quadrant (5-6mm Pockets)	LANAP Quadrant (≥7mm Pockets)	Modified Widman Flap (5-6mm Pockets)	Modified Widman Flap (≥7mm Pockets)	Scaling and Root Planing (5-6mm Pockets)	Scaling and Root Planing (≥7mm Pockets)	Coronal Debridement (5-6mm Pockets)	Coronal Debridement (≥7mm Pockets)
Arm/Group Description:	Treated with LANAP LANAP: Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser	Treated with LANAP LANAP: Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser	Quadrant treated with Modified Widman Flap surgery	Quadrant treated with Modified Widman Flap surgery	Quadrant treated with scaling and root planing alone	Quadrant treated with scaling and root planing alone	Quadrant treated with coronal debridement	Quadrant treated with coronal debridement
Overall Number of Participants Analyzed	52	51	52	51	52	51	52	51
Overall Number of Units Analyzed; Type of Units Analyzed: Pockets	445	234	434	224	495	239	439	210
Mean (Standard Deviation); Unit of Measure: mm
Change in CAL @ 6 mo	1.361 (1.736)	2.387 (2.038)	1.180 (1.587)	2.329 (1.909)	1.347 (1.833)	2.061 (2.243)	0.796 (1.723)	1.573 (1.945)
Change in CAL @ 12 mo	1.498 (1.638)	2.458 (2.005)	1.229 (1.588)	2.120 (1.840)	1.425 (1.810)	2.330 (2.137)	1.033 (1.857)	1.762 (2.082)

2. Secondary Outcome

Title	Change in Probing Depth (PD)
Description	Positive numbers indicate average decrease in probing depth (improvement).
Time Frame	Baseline, 6, 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	LANAP Quadrant	Modified Widman Flap	Scaling and Root Planing	Coronal Debridement
Arm/Group Description:	Treated with LANAP LANAP: Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser	Quadrant treated with Modified Widman Flap surgery	Quadrant treated with scaling and root planing alone	Quadrant treated with coronal debridement
Overall Number of Participants Analyzed	57	57	57	57
Overall Number of Units Analyzed; Type of Units Analyzed: Pockets	487	459	527	476
Mean (Standard Deviation); Unit of Measure: mm
5-6mm @ 6 mo	1.674 (1.402)	1.834 (1.263)	1.550 (1.486)	1.084 (1.544)
5-6mm @ 12 mo	1.888 (1.446)	1.831 (1.305)	1.702 (1.556)	1.223 (1.749)
>=7mm @ 6 mo	2.716 (1.832)	3.117 (1.585)	2.525 (1.897)	1.976 (1.773)
>=7mm @ 12 mo	3.097 (1.766)	3.004 (1.581)	2.846 (2.001)	2.108 (1.959)

3. Secondary Outcome

Title	Change in Bleeding on Probing (BOP)
Description	Percent of pockets within a quadrant that changed from baseline to 6 or 12 months. Negative numbers are a decrease in bleeding on probing which represents clinical improvement. Each quadrant within the patient represents one of four treatments, the unit of analysis. Pockets are replications within treatments and vary in number among quadrants.
Time Frame	Baseline, 6, 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	LANAP Quadrant	Modified Widman Flap	Scaling and Root Planing	Coronal Debridement
Arm/Group Description:	Treated with LANAP LANAP: Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser	Quadrant treated with Modified Widman Flap surgery	Quadrant treated with scaling and root planing alone	Quadrant treated with coronal debridement
Overall Number of Participants Analyzed	57	57	57	57
Overall Number of Units Analyzed; Type of Units Analyzed: Quadrants	57	57	57	57
Mean (Standard Deviation); Unit of Measure: percentage of pockets that bled
change @ 6 mo	-24.9 (32.7)	-22.9 (30.7)	-23.7 (28.0)	-18.0 (31.2)
change @ 12mo	-23.0 (29.7)	-20.4 (28.2)	-20.1 (27.7)	-15.7 (28.4)

4. Secondary Outcome

Title	Change in Gingival Index
Description	The gingival index is a 0-4 unit scale that the examiner uses to estimate the amount of edema and erythema at 2 locations (lingual and buccal) for every tooth in the quadrant. Zero (0) represents no redness and swelling and four (4) represents severe redness and swelling. Negative numbers are a decrease in in examiner estimate of erythema and edema and represent an improvement in clinical outcome.
Time Frame	Baseline, 6, 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	LANAP Quadrant	Modified Widman Flap	Scaling and Root Planing	Coronal Debridement
Arm/Group Description:	Treated with LANAP LANAP: Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser	Quadrant treated with Modified Widman Flap surgery	Quadrant treated with scaling and root planing alone	Quadrant treated with coronal debridement
Overall Number of Participants Analyzed	57	57	57	57
Overall Number of Units Analyzed; Type of Units Analyzed: Locations	832	819	823	810
Mean (Standard Deviation); Unit of Measure: units on a scale from 0-4
6 months	-1.28 (1.28)	-1.30 (1.31)	-1.28 (1.27)	-1.14 (1.28)
12 months	-1.29 (1.19)	-1.27 (1.22)	-1.26 (1.20)	-1.14 (1.22)

5. Secondary Outcome

Title	Discomfort
Description	Subjects recorded in a diary discomfort on a 10 point visual analog scale daily for the week following treatment. Subjects provided an estimate for each of the four treated quadrants. Zero (0) represents no pain or discomfort and ten (10) represents severe pain and/or discomfort. For each subject discomfort scores on each day from Day 1 to Day 7 were summed. Medians and ranges for each treatment are recorded. The total score could range from 0 to 70.
Time Frame	1-7 days

Outcome Measure Data

Analysis Population Description

Subjects with missing data (e.g., missing diary entries) are not included in the analysis.

Arm/Group Title	LANAP Quadrant	Modified Widman Flap	Scaling and Root Planing	Coronal Debridement
Arm/Group Description:	Treated with LANAP LANAP: Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser	Quadrant treated with Modified Widman Flap surgery	Quadrant treated with scaling and root planing alone	Quadrant treated with coronal debridement
Overall Number of Participants Analyzed	54	53	54	53
Overall Number of Units Analyzed; Type of Units Analyzed: Quadrants	54	53	54	53
Median (Full Range); Unit of Measure: sum of units on a scale
	10; (0 to 60.5)	19; (0 to 56)	4.4; (0 to 61.5)	3.5; (0 to 68.5)

Adverse Events

Time Frame	1 year
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	LANAP Quadrant	Modified Widman Flap	Scaling and Root Planing	Coronal Debridement
Arm/Group Description	Treated with LANAP LANAP: Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser	Quadrant treated with Modified Widman Flap surgery	Quadrant treated with scaling and root planing alone	Quadrant treated with coronal debridement
All-Cause Mortality
	LANAP Quadrant	Modified Widman Flap	Scaling and Root Planing	Coronal Debridement
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--	--/--	--/--
Serious Adverse Events
	LANAP Quadrant	Modified Widman Flap	Scaling and Root Planing	Coronal Debridement
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	LANAP Quadrant	Modified Widman Flap	Scaling and Root Planing	Coronal Debridement
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)

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. David Harris
• Organization: Millenium Dental Technologies, Inc
• Phone: 510-502-3345
• EMail: dharris@LANAP.com

• Responsible Party: Institute for Advanced Laser Dentistry
• ClinicalTrials.gov Identifier: NCT01282229
• Other Study ID Numbers: MDT MC 06-001
• First Submitted: January 13, 2011
• First Posted: January 24, 2011
• Results First Submitted: June 18, 2015
• Results First Posted: October 14, 2015
• Last Update Posted: October 14, 2015