Study to Compare Laser Assisted New Attachment Procedure (LANAP) to Traditional Treatments of Chronic Periodontitis (LANAP)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Multi-Center Single Blind Study of the Laser Assisted New Attachment Procedure Compared to Scaling and Root Planing Alone, Modified Widman Flap Surgery, and Coronal Debridement Alone in the Treatment of Chronic Periodontitis|
- Gain in Clinical Attachment Level of Periodontal Tissues [ Time Frame: Baseline, 6, 12 months ] [ Designated as safety issue: No ]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.
- Change in Probing Depth (PD) [ Time Frame: Baseline, 6, 12 months ] [ Designated as safety issue: No ]Positive numbers indicate average decrease in probing depth (improvement).
- Change in Bleeding on Probing (BOP) [ Time Frame: Baseline, 6, 12 months ] [ Designated as safety issue: No ]
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.
- Change in Gingival Index [ Time Frame: Baseline, 6, 12 months ] [ Designated as safety issue: No ]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.
- Discomfort [ Time Frame: 1-7 days ] [ Designated as safety issue: No ]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.
|Study Start Date:||October 2010|
|Study Completion Date:||October 2014|
|Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Active Comparator: LANAP Quadrant
Treated with LANAP
Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser
Other Name: Periolase MVP 7
No Intervention: Modified Widman Flap
Quadrant treated with Modified Widman Flap surgery
No Intervention: Scaling and Root Planing
Quadrant treated with scaling and root planing alone
No Intervention: Coronal Debridement
Quadrant treated with coronal debridement
This multi-center study of the Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser compared to Scaling and Root Planing alone, Modified Widman Flap (MWF) surgery, and Coronal Debridement (CD) alone will utilize a single-blind, four-quadrant split-mouth design with MWF as the positive control, CD as a weak positive control and SRP as the standard treatment control. The study will be conducted at three (3) to five (5) investigational centers. 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 quadrant of their mouth at Baseline. Treatment modalities are randomly assigned to quadrants at the time of treatment.
Efficacy evaluations, including clinical attachment level (CAL), probing depth (PD), and bleeding on probing (BOP) will be performed at Baseline, month 6, and month 12 using a Florida Electronic Probe. Radiographs will be taken at Screening/Baseline and at month 6 and month 12.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01282229
|United States, Colorado|
|University of Colorado|
|Denver, Colorado, United States, 80045|
|Study Director:||Raymund A Yukna, DMD, MS||University of Colorado Scholl of Dentistry|
|Principal Investigator:||Henry Greenwell, DMD. MSD||University of Louisville, School of Dentistry|
|Principal Investigator:||Mark Reynolds, DDS, PhD||University of Maryland, School of Dentistry|
|Principal Investigator:||James Finley, DMD||Finley Periodontics|
|Principal Investigator:||Thomas McCawley, DDS||McCawly & DeTure|