The purpose of this study is to compare the Laser Assisted New Attachment Procedure (LANAP protocol) using the Free-running (FR) Pulsed Neodimium: Yttrium aluminium garnet (Nd:YAG) laser to Scaling and Root Planing (SRP) alone, Modified Widman Flap (MFF) surgery, and Coronal Debridement (CD) alone with respect to periodontal clinical attachment level gain.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
59
Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser
University of Colorado
Denver, Colorado, United States
Gain in Clinical Attachment Level of Periodontal Tissues
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
Change in Probing Depth (PD)
Positive numbers indicate average decrease in probing depth (improvement).
Time frame: Baseline, 6, 12 months
Change in Bleeding on Probing (BOP)
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
Change in Gingival Index
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
Discomfort
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 1-7 days