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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by Ondine Research Laboratories.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Ondine Research Laboratories
ClinicalTrials.gov Identifier:
NCT00297531
First received: February 24, 2006
Last updated: May 17, 2007
Last verified: May 2007
  Purpose

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

Resource links provided by NLM:


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:
  • Decrease in periodontal pocket depth [ Time Frame: 6, 12 weeks ]
  • Reduction in bleeding on probing [ Time Frame: 6, 12 weeks ]

Estimated Enrollment: 120
Study Start Date: April 2006
Estimated Study Completion Date: October 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. 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00297531

Locations
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
Investigators
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
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00297531     History of Changes
Other Study ID Numbers: ORL-0605-4
Study First Received: February 24, 2006
Last Updated: May 17, 2007
Health Authority: Canada: Ethics Review Committee

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

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

ClinicalTrials.gov processed this record on July 20, 2014