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.
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. Primary Endpoint 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 Secondary Endpoints 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
105
Shanghai Second Medical University
Shanghai, China
Wenzhou Hospital Department of Dentistry
Wenzhou, China
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
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