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PerioWave Re-Treatment Protocol Compared to Scaling and Root Planing (SRP) and a Single Treatment With PerioWave

Primary Purpose

Periodontitis

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
PerioWave
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 Periodontitis, Chronic Periodontitis, Gingivitis, PERIOWAVE, Photodynamic Disinfection

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

Sites / Locations

  • Shanghai Second Medical University
  • Wenzhou Hospital Department of Dentistry

Outcomes

Primary Outcome Measures

Improvement in Clinical Attachment Level

Secondary Outcome Measures

Improvement in Periodontal Pocket Depth
Improvement in Bleeding on Probing

Full Information

First Posted
June 12, 2006
Last Updated
May 17, 2007
Sponsor
Ondine Research Laboratories
Collaborators
Loma Linda University
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1. Study Identification

Unique Protocol Identification Number
NCT00336661
Brief Title
PerioWave Re-Treatment Protocol Compared to Scaling and Root Planing (SRP) and a Single Treatment With PerioWave
Official Title
A Multicenter, Randomized, Blinded Study of Two Treatments of Photoactivated Disinfection With SRP Against One Treatment of Photoactivated Disinfection With SRP Against SRP Alone in the Treatment of Chronic Periodontitis
Study Type
Interventional

2. Study Status

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

3. Sponsor/Collaborators

Name of the Sponsor
Ondine Research Laboratories
Collaborators
Loma Linda University

4. Oversight

5. Study Description

Brief Summary
This is a pivotal, prospective, randomized, blinded, multicenter study to evaluate two treatments of photodynamic disinfection in adults with chronic periodontal disease. The study is expected to enroll a total of up to 105 subjects.
Detailed Description
The key question is whether scaling and root planing (SRP) followed by one or two doses of photodynamic disinfection using 0.01% MB result in improved outcomes that persist over time in adults with chronic periodontitis when compared with subjects with SRP alone. This study is meant to be pivotal in nature in the evaluation of photodynamic disinfection. Primary Endpoint The primary outcome of interest in this study is improvement in or stabilization of clinical attachment level. The clinical attachment level is the distance in mm from the cemento-enamel junction to the base of the sulcus or periodontal pocket as measured with a periodontal probe. In order to prevent study bias all endpoint measurements will be performed by a single examiner throughout the course of the study. A clinically significant difference will be considered as: 1) A measurement difference of 0.4 mm between treatment groups Secondary Endpoints The secondary objectives are to assess the effects of photodynamic disinfection on clinical symptoms including reductions in probing depth and decreases in bleeding on probing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
Keywords
Periodontitis, Chronic Periodontitis, Gingivitis, PERIOWAVE, Photodynamic Disinfection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
PerioWave
Primary Outcome Measure Information:
Title
Improvement in Clinical Attachment Level
Time Frame
12-weeks
Secondary Outcome Measure Information:
Title
Improvement in Periodontal Pocket Depth
Time Frame
12-weeks
Title
Improvement in Bleeding on Probing
Time Frame
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rong Shu
Organizational Affiliation
Shanghai Second Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hu Zhong
Organizational Affiliation
Wenzhou Hospital Department of Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Second Medical University
City
Shanghai
Country
China
Facility Name
Wenzhou Hospital Department of Dentistry
City
Wenzhou
Country
China

12. IPD Sharing Statement

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PerioWave Re-Treatment Protocol Compared to Scaling and Root Planing (SRP) and a Single Treatment With PerioWave

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