Status:
COMPLETED
Study of Scaling and Root Planing (SRP) With PerioWave vs. SRP Alone in Chronic Periodontitis
Lead Sponsor:
Ondine Research Laboratories
Conditions:
Periodontitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 c...
Detailed Description
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 alo...
Eligibility Criteria
Inclusion
- 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
- 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
- The subject has smoked tobacco products in the last year
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00297518
Start Date
March 1 2006
End Date
January 1 2007
Last Update
May 21 2007
Active Locations (2)
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1
Office of Dr. Sonia Leziy
North Vancouver, British Columbia, Canada
2
University of British Columbia School of Dentistry
Vancouver, British Columbia, Canada