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Study of Scaling and Root Planing With PerioWave Versus Scaling and Root Planing 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: NCT00297531
Recruitment Status : Unknown
Verified May 2007 by Ondine Research Laboratories.
Recruitment status was:  Active, not recruiting
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 planing (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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Photodynamic Disinfection in Combination With Scaling and Root Planing in the Treatment of Chronic Periodontitis
Study Start Date : April 2006
Estimated Study Completion Date : October 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. Decrease 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

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

Inclusion Criteria:

  1. Adult male or female over the age of 18
  2. Having been diagnosed with chronic periodontitis
  3. >18 fully erupted teeth
  4. Has had no periodontal instrumentation in the four months prior to initiation of study treatment
  5. Subject has at least 4 sites with pocket depth of 6-9 mm in at least two quadrants of the mouth.
  6. Subject is willing and able to return for treatment and evaluation procedures scheduled throughout the course of this clinical study
  7. The subject is capable of giving informed consent
  8. Subject is willing to sign a consent form

Exclusion Criteria:

  1. Is pregnant or nursing or who plans to become pregnant in the next 4 months
  2. Having significant liver disease by subject report
  3. Having an active malignancy of any type by subject report
  4. Having chronic disease or diminished mental capacity that would mitigate the ability to comply with the protocol
  5. Having any significant disease (either acute or chronic) or who is taking medication with concomitant oral manifestations that in the opinion of the investigator would interfere with evaluation of safety or efficacy of PerioWave®
  6. Having an active periapical abscess or periodontal abscess or a history of acute necrotizing ulcerative gingivitis
  7. Treatment 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. Known allergy to methylene blue
  9. Has glucose-6-phosphate dehydrogenase (G6PD) deficiency by subject report
  10. Currently uses anti-coagulant therapy at therapeutic doses
  11. Currently uses photosensitizing medications
  12. Participated in investigational treatment in the last 30 days or expectation for using a separate investigational treatment during the time of the study

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): NCT00297531

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Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2N8
Canada, Ontario
University of Western Ontario
London, Ontario, Canada, N6G 4L1
North York Dental Center
Toronto, Ontario, Canada
Canada, Saskatchewan
University of Saskatchewan
Saskatoon, Saskatchewan, Canada
Sponsors and Collaborators
Ondine Research Laboratories
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Principal Investigator: Sharon Compton, PhD University of Alberta
Principal Investigator: Harinder Sandhu, DMD/PhD University of Western Ontario, Canada
Principal Investigator: Jay Hoover, DDS University of Saskatchewan
Principal Investigator: Cary Galler, DDS North York Dental Center


Layout table for additonal information Identifier: NCT00297531     History of Changes
Other Study ID Numbers: ORL-0605-4
First Posted: February 28, 2006    Key Record Dates
Last Update Posted: May 21, 2007
Last Verified: May 2007
Keywords provided by Ondine Research Laboratories:
Chronic Periodontitis
Photodynamic disinfection
Scaling and Root Planing
Additional relevant MeSH terms:
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Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases