NCT01282229

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Institute for Advanced Laser Dentistry · Academic / Other
• Sex: All
• Age: 25 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Chronic Periodontitis

Interventions

Type	Name	Description
DEVICE	LANAP	Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser

Timeline

• Start date: 2010-10-01
• Primary completion: 2014-03-01
• Completion: 2014-10-01
• First posted: 2011-01-24
• Last updated: 2015-10-14
• Results posted: 2015-10-14

Locations

1 site across 1 country: United States