PerioWave Re-Treatment Protocol Compared to Scaling and Root Planing (SRP) and a Single Treatment With PerioWave
Periodontitis
About this trial
This is an interventional treatment trial for Periodontitis focused on measuring Periodontitis, Chronic Periodontitis, Gingivitis, PERIOWAVE, Photodynamic Disinfection
Eligibility Criteria
Inclusion Criteria: The subject is capable of giving informed consent The subject is willing to sign a consent form The subject is an adult male or female > 18 The subject is diagnosed with chronic periodontitis The subject has >18 fully erupted teeth The subject has at least 4 measurement sites with pocket depth of 6-9 mm in at least two quadrants of the mouth. Subject is willing and able to return for treatment and evaluation procedures scheduled throughout the course of this clinical study Exclusion Criteria: The subject is pregnant or nursing or who plans to become pregnant in the next 4 months The subject has significant liver disease by subject report The subject has an active malignancy of any type by subject report The subject has chronic disease or diminished mental capacity that would mitigate the ability to comply with the protocol The subject has any significant disease (either acute or chronic) or who is taking a medication with concomitant oral manifestations that in the opinion of the investigator would interfere with evaluation of safety or efficacy of PERIOWAVE® The subject has an active periapical abscess or periodontal abscess or a history of acute necrotizing ulcerative gingivitis The subject has been treated with antibiotics within 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 The subject has a known allergy to Methylene Blue Has glucose-6-phosphate dehydrogenase (G6PD) deficiency by subject report The subject currently uses anti-coagulant therapy at therapeutic doses The subject is currently using any photosensitizing medications The subject has participated in investigational treatment in the last 30 days or has the expectation for using a separate investigational treatment during the time of the study
Sites / Locations
- Shanghai Second Medical University
- Wenzhou Hospital Department of Dentistry