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

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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:
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Participants
Hide 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)
Arm/Group Title All Participants
Hide 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
Hide 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).
1.Primary Outcome
Title Gain in Clinical Attachment Level of Periodontal Tissues
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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)
Hide Description Positive numbers indicate average decrease in probing depth (improvement).
Time Frame Baseline, 6, 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LANAP Quadrant Modified Widman Flap Scaling and Root Planing Coronal Debridement
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LANAP Quadrant Modified Widman Flap Scaling and Root Planing Coronal Debridement
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LANAP Quadrant Modified Widman Flap Scaling and Root Planing Coronal Debridement
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LANAP Quadrant Modified Widman Flap Scaling and Root Planing Coronal Debridement
Hide 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   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide 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%) 
Show Other (Not Including Serious) Adverse Events Hide 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%) 
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
Responsible Party: Institute for Advanced Laser Dentistry
ClinicalTrials.gov Identifier: NCT01282229     History of Changes
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