SRP in Combination With PERIOWAVE in Comparison to SRP Alone in Chronic Periodontitis

Launched by ONDINE RESEARCH LABORATORIES · Feb 24, 2006

Keywords

ClinConnect Summary

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 associa...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. The subject is capable of giving informed consent
• • 2. Subject is willing to sign a consent form
• • 3. Adult male or female ≥ the age of 18
• • 4. Having been diagnosed with chronic periodontitis
• • 5. \>18 fully erupted teeth
• • 6. Has had no periodontal instrumentation in the four months prior to the initiation of study treatment
• • 7. Subject has at least 4 sites with pocket depth of 6-9 mm in at least two quadrants of the mouth.
• • 8. Subject is willing and able to return for treatment and evaluation procedures scheduled throughout the course of this clinical study
• Exclusion Criteria:
• • 1. Is pregnant or nursing or who plans to become pregnant in the next 4 months
• • 2. Having significant liver disease by subject report
• • 3. Having an active malignancy of any type by subject report
• • 4. Having chronic disease or diminished mental capacity that would mitigate the ability to comply with the protocol
• • 5. Having any significant chronic disease (either acute or chronic) with concomitant oral manifestations that in the opinion of the investigator would interfere with evaluation of safety or efficacy of PerioWave®
• • 6. Having an active periapical abscess or periodontal abscess
• • 7. Treatment with antibiotics with in the 1-month period prior to beginning the study or any systemic condition which requires antibiotic coverage for routine periodontal procedures (e.g. heart conditions, joint replacements, etc) by report of the subject
• • 8. History of acute necrotizing ulcerative gingivitis
• • 9. Known allergy to Methylene Blue
• • 10. Has glucose-6-phosphate dehydrogenase (G6PD) deficiency by subject report
• • 11. Currently uses anti-coagulant therapy at therapeutic doses
• • 12. Currently uses photosensitizing medications
• • 13. Participated in investigational treatment in the last 30 days or expectation for using a separate investigational treatment during the time of the study