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Sponsored by: |
Ondine Research Laboratories |
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Information provided by: | Ondine Research Laboratories |
ClinicalTrials.gov Identifier: | NCT00296881 |
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.
Condition | Intervention | Phase |
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Periodontitis |
Device: PERIOWAVE |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Enrollment: | 80 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United Kingdom | |
UCL Eastman Dental Institute | |
London, United Kingdom, WC1X 8LD |
Principal Investigator: | Nikos Donos, DDS, MS, PhD | University College London, Eastman Dental Institute |
Study ID Numbers: | ORL-0605-3 |
Study First Received: | February 23, 2006 |
Last Updated: | May 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00296881 |
Health Authority: | United Kingdom: Research Ethics Committee |
Periodontitis Photodynamic Disinfection PERIOWAVE Scaling and Root Planing SRP |
Mouth Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases |