Trial Outcomes & Findings for Study to Compare Laser Assisted New Attachment Procedure (LANAP) to Traditional Treatments of Chronic Periodontitis (NCT NCT01282229)

Last Updated: 2015-10-14

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

59 participants

Primary outcome timeframe

Baseline, 6, 12 months

Results posted on

2015-10-14

Participant Flow

Participant milestones

Participant milestones
Measure	All Participants 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 Study STARTED	59
Overall Study COMPLETED	57
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	All Participants 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 Study Protocol Violation	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=57 Participants 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.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	51 Participants n=93 Participants
Age, Categorical >=65 years	6 Participants n=93 Participants
Sex: Female, Male Female	27 Participants n=93 Participants
Sex: Female, Male Male	30 Participants n=93 Participants
Average Probing Depth (PD) PD = 5-6mm (LANAP Quadrant)	5.364 mm STANDARD_DEVIATION .553 • n=93 Participants
Average Probing Depth (PD) PD = 5-6mm ( Modified Widman Flap)	5.358 mm STANDARD_DEVIATION .569 • n=93 Participants
Average Probing Depth (PD) PD = 5-6mm (Scaling and Root Planing)	5.358 mm STANDARD_DEVIATION .570 • n=93 Participants
Average Probing Depth (PD) PD = 5-6mm (Coronal Debridement)	5.382 mm STANDARD_DEVIATION .554 • n=93 Participants
Average Probing Depth (PD) PD >= 7mm (LANAP Quadrant)	7.606 mm STANDARD_DEVIATION .867 • n=93 Participants
Average Probing Depth (PD) PD >= 7mm (Modified Widman Flap)	7.562 mm STANDARD_DEVIATION .901 • n=93 Participants
Average Probing Depth (PD) PD >= 7mm (Scaling and Root Planing)	7.657 mm STANDARD_DEVIATION .967 • n=93 Participants
Average Probing Depth (PD) PD >= 7mm (Coronal Debridement)	7.672 mm STANDARD_DEVIATION 1.069 • n=93 Participants
Average Clinical Attachment Level (CAL) PD = 5-6mm (LANAP Quadrant)	5.431 mm STANDARD_DEVIATION 1.301 • n=93 Participants
Average Clinical Attachment Level (CAL) PD = 5-6mm ( Modified Widman Flap)	5.440 mm STANDARD_DEVIATION 1.349 • n=93 Participants
Average Clinical Attachment Level (CAL) PD = 5-6mm (Scaling and Root Planing)	5.364 mm STANDARD_DEVIATION 1.244 • n=93 Participants
Average Clinical Attachment Level (CAL) PD = 5-6mm (Coronal Debridement)	5.468 mm STANDARD_DEVIATION 1.486 • n=93 Participants
Average Clinical Attachment Level (CAL) PD >= 7mm (LANAP Quadrant)	7.453 mm STANDARD_DEVIATION 1.594 • n=93 Participants
Average Clinical Attachment Level (CAL) PD >= 7mm (Modified Widman Flap)	7.737 mm STANDARD_DEVIATION 1.586 • n=93 Participants
Average Clinical Attachment Level (CAL) PD >= 7mm (Scaling and Root Planing)	7.528 mm STANDARD_DEVIATION 1.751 • n=93 Participants
Average Clinical Attachment Level (CAL) PD >= 7mm (Coronal Debridement)	7.681 mm STANDARD_DEVIATION 1.659 • n=93 Participants
Bleeding on Probing (BOP) LANAP Quadrant	49.4 percentage of pockets STANDARD_DEVIATION 31.4 • n=93 Participants
Bleeding on Probing (BOP) Modified Widman Flap	46.5 percentage of pockets STANDARD_DEVIATION 31.2 • n=93 Participants
Bleeding on Probing (BOP) Scaling and Root Planing	48.2 percentage of pockets STANDARD_DEVIATION 30.6 • n=93 Participants
Bleeding on Probing (BOP) Coronal Debridement	47.5 percentage of pockets STANDARD_DEVIATION 31.2 • n=93 Participants
Gingival Index (GI) LANAP Quadrant	2.48 units on a scale STANDARD_DEVIATION 0.95 • n=93 Participants
Gingival Index (GI) Modified Widman Flap	2.42 units on a scale STANDARD_DEVIATION 0.95 • n=93 Participants
Gingival Index (GI) Scaling and Root Planing	2.44 units on a scale STANDARD_DEVIATION 0.96 • n=93 Participants
Gingival Index (GI) Coronal Debridement	2.43 units on a scale STANDARD_DEVIATION 0.95 • n=93 Participants

PRIMARY outcome

Timeframe: Baseline, 6, 12 months

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

Outcome measures

Outcome measures
Measure	LANAP Quadrant (5-6mm Pockets) n=445 pockets Treated with LANAP LANAP: Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser	LANAP Quadrant (≥7mm Pockets) n=234 pockets Treated with LANAP LANAP: Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser	Modified Widman Flap (5-6mm Pockets) n=434 pockets Quadrant treated with Modified Widman Flap surgery	Modified Widman Flap (≥7mm Pockets) n=224 pockets Quadrant treated with Modified Widman Flap surgery	Scaling and Root Planing (5-6mm Pockets) n=495 pockets Quadrant treated with scaling and root planing alone	Scaling and Root Planing (≥7mm Pockets) n=239 pockets Quadrant treated with scaling and root planing alone	Coronal Debridement (5-6mm Pockets) n=439 pockets Quadrant treated with coronal debridement	Coronal Debridement (≥7mm Pockets) n=210 pockets Quadrant treated with coronal debridement
Gain in Clinical Attachment Level of Periodontal Tissues Change in CAL @ 6 mo	1.361 mm Standard Deviation 1.736	2.387 mm Standard Deviation 2.038	1.180 mm Standard Deviation 1.587	2.329 mm Standard Deviation 1.909	1.347 mm Standard Deviation 1.833	2.061 mm Standard Deviation 2.243	0.796 mm Standard Deviation 1.723	1.573 mm Standard Deviation 1.945
Gain in Clinical Attachment Level of Periodontal Tissues Change in CAL @ 12 mo	1.498 mm Standard Deviation 1.638	2.458 mm Standard Deviation 2.005	1.229 mm Standard Deviation 1.588	2.120 mm Standard Deviation 1.840	1.425 mm Standard Deviation 1.810	2.330 mm Standard Deviation 2.137	1.033 mm Standard Deviation 1.857	1.762 mm Standard Deviation 2.082

SECONDARY outcome

Timeframe: Baseline, 6, 12 months

Positive numbers indicate average decrease in probing depth (improvement).

Outcome measures

Outcome measures
Measure	LANAP Quadrant (5-6mm Pockets) n=487 pockets Treated with LANAP LANAP: Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser	LANAP Quadrant (≥7mm Pockets) n=459 pockets Treated with LANAP LANAP: Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser	Modified Widman Flap (5-6mm Pockets) n=527 pockets Quadrant treated with Modified Widman Flap surgery	Modified Widman Flap (≥7mm Pockets) n=476 pockets Quadrant treated with Modified Widman Flap surgery	Scaling and Root Planing (5-6mm Pockets) Quadrant treated with scaling and root planing alone	Scaling and Root Planing (≥7mm Pockets) Quadrant treated with scaling and root planing alone	Coronal Debridement (5-6mm Pockets) Quadrant treated with coronal debridement	Coronal Debridement (≥7mm Pockets) Quadrant treated with coronal debridement
Change in Probing Depth (PD) 5-6mm @ 6 mo	1.674 mm Standard Deviation 1.402	1.834 mm Standard Deviation 1.263	1.550 mm Standard Deviation 1.486	1.084 mm Standard Deviation 1.544	—	—	—	—
Change in Probing Depth (PD) 5-6mm @ 12 mo	1.888 mm Standard Deviation 1.446	1.831 mm Standard Deviation 1.305	1.702 mm Standard Deviation 1.556	1.223 mm Standard Deviation 1.749	—	—	—	—
Change in Probing Depth (PD) >=7mm @ 6 mo	2.716 mm Standard Deviation 1.832	3.117 mm Standard Deviation 1.585	2.525 mm Standard Deviation 1.897	1.976 mm Standard Deviation 1.773	—	—	—	—
Change in Probing Depth (PD) >=7mm @ 12 mo	3.097 mm Standard Deviation 1.766	3.004 mm Standard Deviation 1.581	2.846 mm Standard Deviation 2.001	2.108 mm Standard Deviation 1.959	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, 6, 12 months

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.

Outcome measures

Outcome measures
Measure	LANAP Quadrant (5-6mm Pockets) n=57 quadrants Treated with LANAP LANAP: Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser	LANAP Quadrant (≥7mm Pockets) n=57 Participants Treated with LANAP LANAP: Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser	Modified Widman Flap (5-6mm Pockets) n=57 Participants Quadrant treated with Modified Widman Flap surgery	Modified Widman Flap (≥7mm Pockets) n=57 Participants Quadrant treated with Modified Widman Flap surgery	Scaling and Root Planing (5-6mm Pockets) Quadrant treated with scaling and root planing alone	Scaling and Root Planing (≥7mm Pockets) Quadrant treated with scaling and root planing alone	Coronal Debridement (5-6mm Pockets) Quadrant treated with coronal debridement	Coronal Debridement (≥7mm Pockets) Quadrant treated with coronal debridement
Change in Bleeding on Probing (BOP) change @ 12mo	-23.0 percentage of pockets that bled Standard Deviation 29.7	-20.4 percentage of pockets that bled Standard Deviation 28.2	-20.1 percentage of pockets that bled Standard Deviation 27.7	-15.7 percentage of pockets that bled Standard Deviation 28.4	—	—	—	—
Change in Bleeding on Probing (BOP) change @ 6 mo	-24.9 percentage of pockets that bled Standard Deviation 32.7	-22.9 percentage of pockets that bled Standard Deviation 30.7	-23.7 percentage of pockets that bled Standard Deviation 28.0	-18.0 percentage of pockets that bled Standard Deviation 31.2	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, 6, 12 months

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.

Outcome measures

Outcome measures
Measure	LANAP Quadrant (5-6mm Pockets) n=832 locations Treated with LANAP LANAP: Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser	LANAP Quadrant (≥7mm Pockets) n=819 locations Treated with LANAP LANAP: Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser	Modified Widman Flap (5-6mm Pockets) n=823 locations Quadrant treated with Modified Widman Flap surgery	Modified Widman Flap (≥7mm Pockets) n=810 locations Quadrant treated with Modified Widman Flap surgery	Scaling and Root Planing (5-6mm Pockets) Quadrant treated with scaling and root planing alone	Scaling and Root Planing (≥7mm Pockets) Quadrant treated with scaling and root planing alone	Coronal Debridement (5-6mm Pockets) Quadrant treated with coronal debridement	Coronal Debridement (≥7mm Pockets) Quadrant treated with coronal debridement
Change in Gingival Index 6 months	-1.28 units on a scale from 0-4 Standard Deviation 1.28	-1.30 units on a scale from 0-4 Standard Deviation 1.31	-1.28 units on a scale from 0-4 Standard Deviation 1.27	-1.14 units on a scale from 0-4 Standard Deviation 1.28	—	—	—	—
Change in Gingival Index 12 months	-1.29 units on a scale from 0-4 Standard Deviation 1.19	-1.27 units on a scale from 0-4 Standard Deviation 1.22	-1.26 units on a scale from 0-4 Standard Deviation 1.20	-1.14 units on a scale from 0-4 Standard Deviation 1.22	—	—	—	—

SECONDARY outcome

Timeframe: 1-7 days

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

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.

Outcome measures

Outcome measures
Measure	LANAP Quadrant (5-6mm Pockets) n=54 quadrants Treated with LANAP LANAP: Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser	LANAP Quadrant (≥7mm Pockets) n=53 quadrants Treated with LANAP LANAP: Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser	Modified Widman Flap (5-6mm Pockets) n=54 quadrants Quadrant treated with Modified Widman Flap surgery	Modified Widman Flap (≥7mm Pockets) n=53 quadrants Quadrant treated with Modified Widman Flap surgery	Scaling and Root Planing (5-6mm Pockets) Quadrant treated with scaling and root planing alone	Scaling and Root Planing (≥7mm Pockets) Quadrant treated with scaling and root planing alone	Coronal Debridement (5-6mm Pockets) Quadrant treated with coronal debridement	Coronal Debridement (≥7mm Pockets) Quadrant treated with coronal debridement
Discomfort	10 sum of units on a scale Interval 0.0 to 60.5	19 sum of units on a scale Interval 0.0 to 56.0	4.4 sum of units on a scale Interval 0.0 to 61.5	3.5 sum of units on a scale Interval 0.0 to 68.5	—	—	—	—

Adverse Events

LANAP Quadrant

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Modified Widman Flap

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Scaling and Root Planing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Coronal Debridement

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. David Harris

Millenium Dental Technologies, Inc

Phone: 510-502-3345

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place