PerioWave Re-Treatment Protocol Compared to Scaling and Root Planing (SRP) and a Single Treatment With PerioWave
This is a pivotal, prospective, randomized, blinded, multicenter study to evaluate two treatments of photodynamic disinfection in adults with chronic periodontal disease. The study is expected to enroll a total of up to 105 subjects.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
|Official Title:||A Multicenter, Randomized, Blinded Study of Two Treatments of Photoactivated Disinfection With SRP Against One Treatment of Photoactivated Disinfection With SRP Against SRP Alone in the Treatment of Chronic Periodontitis|
- Improvement in Clinical Attachment Level [ Time Frame: 12-weeks ]
- Improvement in Periodontal Pocket Depth [ Time Frame: 12-weeks ]
- Improvement in Bleeding on Probing [ Time Frame: 12-weeks ]
|Study Start Date:||January 2006|
|Study Completion Date:||December 2006|
The key question is whether scaling and root planing (SRP) followed by one or two doses of photodynamic disinfection using 0.01% MB result in improved outcomes that persist over time in adults with chronic periodontitis when compared with subjects with SRP alone. This study is meant to be pivotal in nature in the evaluation of photodynamic disinfection.
The primary outcome of interest in this study is improvement in or stabilization of clinical attachment level. The clinical attachment level is the distance in mm from the cemento-enamel junction to the base of the sulcus or periodontal pocket as measured with a periodontal probe. In order to prevent study bias all endpoint measurements will be performed by a single examiner throughout the course of the study. A clinically significant difference will be considered as:
1) A measurement difference of 0.4 mm between treatment groups
The secondary objectives are to assess the effects of photodynamic disinfection on clinical symptoms including reductions in probing depth and decreases in bleeding on probing.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00336661
|Shanghai Second Medical University|
|Wenzhou Hospital Department of Dentistry|
|Principal Investigator:||Rong Shu||Shanghai Second Medical University|
|Principal Investigator:||Hu Zhong||Wenzhou Hospital Department of Dentistry|