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Sponsored by: |
Ondine Research Laboratories |
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Information provided by: | Ondine Research Laboratories |
ClinicalTrials.gov Identifier: | NCT00297531 |
This study is to determine whether scaling and root planing (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.
Condition | Intervention | Phase |
---|---|---|
Periodontitis |
Device: PerioWave Procedure: Scaling and Root Planing |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Photodynamic Disinfection in Combination With Scaling and Root Planing in the Treatment of Chronic Periodontitis |
Estimated Enrollment: | 120 |
Study Start Date: | April 2006 |
Estimated Study Completion Date: | October 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Alberta | |
University of Alberta | |
Edmonton, Alberta, Canada, T6G 2N8 | |
Canada, Ontario | |
University of Western Ontario | |
London, Ontario, Canada, N6G 4L1 | |
North York Dental Center | |
Toronto, Ontario, Canada | |
Canada, Saskatchewan | |
University of Saskatchewan | |
Saskatoon, Saskatchewan, Canada |
Principal Investigator: | Sharon Compton, PhD | University of Alberta |
Principal Investigator: | Harinder Sandhu, DMD/PhD | University of Western Ontario, Canada |
Principal Investigator: | Jay Hoover, DDS | University of Saskatchewan |
Principal Investigator: | Cary Galler, DDS | North York Dental Center |
Study ID Numbers: | ORL-0605-4 |
Study First Received: | February 24, 2006 |
Last Updated: | May 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00297531 |
Health Authority: | Canada: Ethics Review Committee |
Chronic Periodontitis Periodontitis Photodynamic disinfection PDD |
PDT Periowave Scaling and Root Planing SRP |
Mouth Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases |