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Study of Scaling and Root Planing (SRP) With PerioWave vs. SRP Alone in Chronic Periodontitis

This study has been completed.
Sponsor:
Information provided by:
Ondine Research Laboratories
ClinicalTrials.gov Identifier:
NCT00297518
First received: February 24, 2006
Last updated: May 17, 2007
Last verified: May 2007
History of Changes
  Purpose

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
Periodontitis
 Device: PerioWave
Procedure: Scaling and Root Planing
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Examiner Blinded Study of Photoactivated Disinfection With Scaling and Root Planing in the Treatment of Chronic Periodontitis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ondine Research Laboratories:

Primary Outcome Measures:
  • Increase in Clinical Attachment Level [ Time Frame: 6, 12 weeks ]

Secondary Outcome Measures:
  • Reduction in Periodontal Pocket Depth [ Time Frame: 6, 12 weeks ]
  • Reduction in Bleeding on Probing [ Time Frame: 6, 12 weeks ]

Enrollment: 40
Study Start Date: March 2006
Study Completion Date: January 2007
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00297518

Locations
Canada, British Columbia
Office of Dr. Sonia Leziy
North Vancouver, British Columbia, Canada
University of British Columbia School of Dentistry
Vancouver, British Columbia, Canada
Sponsors and Collaborators
Ondine Research Laboratories
Investigators
Principal Investigator: Edward Putnins, DDS University of British Columbia
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00297518     History of Changes
Other Study ID Numbers: ORL-0605-5
Study First Received: February 24, 2006
Last Updated: May 17, 2007
Health Authority: Canada: Ethics Review Committee

Keywords provided by Ondine Research Laboratories:
Adult Periodontitis
Chronic Periodontitis
PDD
PDT
 Photodynamic Disinfection
SRP
Scaling and Root Planing

Additional relevant MeSH terms:
Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on May 23, 2013