Periodontitis Clinical Trial
Official title:
A Multicenter, Randomized, Examiner Blinded Study of Photoactivated Disinfection With Scaling and Root Planing in the Treatment of Chronic Periodontitis
This study is to determine whether scaling and root planning (SRP) followed by photodynamic disinfection results in improved outcomes that persist over time in adults with chronic periodontitis when compared with subjects with SRP alone.
Extensive research has shown that lethal photosensitization with low levels of laser light
is an effective method of killing numerous types of organisms. This therapy avoids the use
of antibiotics along with their potential side effects. The initial application of this
therapy to the oral cavity is particularly appropriate since the therapy can be applied
topically either in a specific or general fashion, killing is immediate and resistance is
unlikely as it is free radical-mediated. In addition, the disease states being treated
(gingivitis & periodontitis) are highly prevalent and associated with significant morbidity.
The equipment and costs of this therapy are simple, easily applied and relatively
inexpensive compared with current therapies. Based on the scientific data to date this
therapy has the potential of significantly improving the oral health of those affected.
This is a pivotal, prospective, randomized, examiner blinded, multicenter study to evaluate
the effect of a single treatment of photodynamic disinfection in adults with chronic
periodontal disease.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
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