SRP in Combination With PERIOWAVE in Comparison to SRP Alone in Chronic Periodontitis
Recruitment status was Active, not recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
|Official Title:||Clinical Outcomes Following Non-Surgical Treatment of Chronic Periodontitis, Using Scaling and Root Planing (SRP) in Conjunction With PerioWave, Compared to SRP Alone|
- Decrease in Periodontal Pocket Depth [ Time Frame: 6, 12, 24, 36, 48 weeks ]
- Reduction in Bleeding on Probing [ Time Frame: 6, 12, 24, 36, 48 weeks ]
- Increase in Clinical Attachment Level [ Time Frame: 6, 12, 24, 36, 48 weeks ]
|Study Start Date:||April 2006|
|Estimated Study Completion Date:||December 2007|
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.
|UCL Eastman Dental Institute|
|London, United Kingdom, WC1X 8LD|
|Principal Investigator:||Nikos Donos, DDS, MS, PhD||University College London, Eastman Dental Institute|