Study of Scaling and Root Planing With PerioWave Versus Scaling and Root Planing Alone in Chronic Periodontitis

May 17, 2007 updated by: Ondine Research Laboratories

Photodynamic Disinfection in Combination With Scaling and Root Planing in the Treatment of Chronic Periodontitis

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2N8
        • University of Alberta
    • Ontario
      • London, Ontario, Canada, N6G 4L1
        • University of Western Ontario
      • Toronto, Ontario, Canada
        • North York Dental Center
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
        • University of Saskatchewan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Increase in clinical attachment level
Time Frame: 6, 12 weeks
6, 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Decrease in periodontal pocket depth
Time Frame: 6, 12 weeks
6, 12 weeks
Reduction in bleeding on probing
Time Frame: 6, 12 weeks
6, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ondine Research Laboratories

Investigators

  • Principal Investigator: Sharon Compton, PhD, University of Alberta
  • Principal Investigator: Harinder Sandhu, DMD/PhD, Western University, Canada
  • Principal Investigator: Jay Hoover, DDS, University of Saskatchewan
  • Principal Investigator: Cary Galler, DDS, North York Dental Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Study Completion (Anticipated)

October 1, 2007

Study Registration Dates

First Submitted

February 24, 2006

First Submitted That Met QC Criteria

February 24, 2006

First Posted (Estimate)

February 28, 2006

Study Record Updates

Last Update Posted (Estimate)

May 21, 2007

Last Update Submitted That Met QC Criteria

May 17, 2007

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORL-0605-4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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