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

Primary Purpose

Periodontitis

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
PerioWave
Scaling and Root Planing
Sponsored by
Ondine Research Laboratories
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring Adult Periodontitis, Chronic Periodontitis, PDD, PDT, Photodynamic Disinfection, SRP, Scaling and Root Planing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The subject is capable of giving informed consent The subject is willing to sign a consent form The subject is an adult male or female > 18 The subject is diagnosed with chronic periodontitis The subject has >18 fully erupted teeth The subject has at least 4 measurement 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 Exclusion Criteria: The subject is pregnant or nursing or who plans to become pregnant in the next 4 months The subject has significant liver disease by subject report The subject has an active malignancy of any type by subject report The subject has chronic disease or diminished mental capacity that would mitigate the ability to comply with the protocol 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® The subject has an active periapical abscess or periodontal abscess or a history of acute necrotizing ulcerative gingivitis 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 The subject has a known allergy to Methylene Blue Has glucose-6-phosphate dehydrogenase (G6PD) deficiency by subject report The subject currently uses anti-coagulant therapy at therapeutic doses The subject is currently using any photosensitizing medications 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 The subject has smoked tobacco products in the last year

Sites / Locations

  • Office of Dr. Sonia Leziy
  • University of British Columbia School of Dentistry

Outcomes

Primary Outcome Measures

Increase in Clinical Attachment Level

Secondary Outcome Measures

Reduction in Periodontal Pocket Depth
Reduction in Bleeding on Probing

Full Information

First Posted
February 24, 2006
Last Updated
May 17, 2007
Sponsor
Ondine Research Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00297518
Brief Title
Study of Scaling and Root Planing (SRP) With PerioWave vs. SRP Alone in Chronic Periodontitis
Official Title
A Multicenter, Randomized, Examiner Blinded Study of Photoactivated Disinfection With Scaling and Root Planing in the Treatment of Chronic Periodontitis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ondine Research Laboratories

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
Keywords
Adult Periodontitis, Chronic Periodontitis, PDD, PDT, Photodynamic Disinfection, SRP, Scaling and Root Planing

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
PerioWave
Intervention Type
Procedure
Intervention Name(s)
Scaling and Root Planing
Primary Outcome Measure Information:
Title
Increase in Clinical Attachment Level
Time Frame
6, 12 weeks
Secondary Outcome Measure Information:
Title
Reduction in Periodontal Pocket Depth
Time Frame
6, 12 weeks
Title
Reduction in Bleeding on Probing
Time Frame
6, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The subject is capable of giving informed consent The subject is willing to sign a consent form The subject is an adult male or female > 18 The subject is diagnosed with chronic periodontitis The subject has >18 fully erupted teeth The subject has at least 4 measurement 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 Exclusion Criteria: The subject is pregnant or nursing or who plans to become pregnant in the next 4 months The subject has significant liver disease by subject report The subject has an active malignancy of any type by subject report The subject has chronic disease or diminished mental capacity that would mitigate the ability to comply with the protocol 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® The subject has an active periapical abscess or periodontal abscess or a history of acute necrotizing ulcerative gingivitis 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 The subject has a known allergy to Methylene Blue Has glucose-6-phosphate dehydrogenase (G6PD) deficiency by subject report The subject currently uses anti-coagulant therapy at therapeutic doses The subject is currently using any photosensitizing medications 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 The subject has smoked tobacco products in the last year
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward Putnins, DDS
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Office of Dr. Sonia Leziy
City
North Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
University of British Columbia School of Dentistry
City
Vancouver
State/Province
British Columbia
Country
Canada

12. IPD Sharing Statement

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

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