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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00297518
Recruitment Status : Completed
First Posted : February 28, 2006
Last Update Posted : May 21, 2007
Information provided by:
Ondine Research Laboratories

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.

Condition or disease Intervention/treatment Phase
Periodontitis Device: PerioWave Procedure: Scaling and Root Planing Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
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
Study Start Date : March 2006
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00297518

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
Principal Investigator: Edward Putnins, DDS University of British Columbia

Publications: Identifier: NCT00297518     History of Changes
Other Study ID Numbers: ORL-0605-5
First Posted: February 28, 2006    Key Record Dates
Last Update Posted: May 21, 2007
Last Verified: May 2007

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

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