Clinical trial NCT00297518: Study of Scaling and Root Planing (SRP) With PerioWave vs. SRP Alone in Chronic Periodontitis
Official title: A Multicenter, Randomized, Examiner Blinded Study of Photoactivated Disinfection With Scaling and Root Planing in the Treatment of Chronic Periodontitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Periodontitis
Keywords: Adult Periodontitis
Chronic Periodontitis
PDD
PDT
Photodynamic Disinfection
SRP
Scaling and Root Planing
Lead sponsor: Ondine Research Laboratories
Sponsor class: INDUSTRY
First posted: 2006-02-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 compared with subjects with SRP alone.

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 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.

Eligibility criteria: Inclusion Criteria:

1. The subject is capable of giving informed consent
2. The subject is willing to sign a consent form
3. The subject is an adult male or female \> 18
4. The subject is diagnosed with chronic periodontitis
5. The subject has \>18 fully erupted teeth
6. The subject has at least 4 measurement sites with pocket depth of 6-9 mm in at least two quadrants of the mouth.
7. Subject is willing and able to return for treatment and evaluation procedures scheduled throughout the course of this clinical study

Exclusion Criteria:

1. The subject is pregnant or nursing or who plans to become pregnant in the next 4 months
2. The subject has significant liver disease by subject report
3. The subject has an active malignancy of any type by subject report
4. The subject has chronic disease or diminished mental capacity that would mitigate the ability to comply with the protocol
5. 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®
6. The subject has an active periapical abscess or periodontal abscess or a history of acute necrotizing ulcerative gingivitis
7. 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
8. The subject has a known allergy to Methylene Blue
9. Has glucose-6-phosphate dehydrogenase (G6PD) deficiency by subject report
10. The subject currently uses anti-coagulant therapy at therapeutic doses
11. The subject is currently using any photosensitizing medications
12. 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
13. The subject has smoked tobacco products in the last year

Primary outcomes:
measure: Increase in Clinical Attachment Level
timeFrame: 6, 12 weeks
Secondary outcomes:
measure: Reduction in Periodontal Pocket Depth
timeFrame: 6, 12 weeks
measure: Reduction in Bleeding on Probing
timeFrame: 6, 12 weeks
Other outcomes:
Locations:
city: North Vancouver
country: Canada
facility: Office of Dr. Sonia Leziy
state: British Columbia
city: Vancouver
country: Canada
facility: University of British Columbia School of Dentistry
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Edward Putnins, DDS
role: PRINCIPAL_INVESTIGATOR
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