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

First Received on February 24, 2006. Last Updated on May 17, 2007 History of Changes

Sponsor:	Ondine Research Laboratories
Information provided by:	Ondine Research Laboratories
ClinicalTrials.gov Identifier:	NCT00297531

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 IV

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

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:

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

Exclusion Criteria:

Is pregnant or nursing or who plans to become pregnant in the next 4 months
Having significant liver disease by subject report
Having an active malignancy of any type by subject report
Having chronic disease or diminished mental capacity that would mitigate the ability to comply with the protocol
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®
Having an active periapical abscess or periodontal abscess or a history of acute necrotizing ulcerative gingivitis
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
Known allergy to methylene blue
Has glucose-6-phosphate dehydrogenase (G6PD) deficiency by subject report
Currently uses anti-coagulant therapy at therapeutic doses
Currently uses photosensitizing medications
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

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

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