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SRP in Combination With PERIOWAVE in Comparison to SRP Alone in Chronic Periodontitis

Primary Purpose

Periodontitis

Status
Unknown status
Phase
Phase 4
Locations
United Kingdom
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, Photodynamic Disinfection, PERIOWAVE, Scaling and Root Planing, SRP

Eligibility Criteria

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

Inclusion Criteria: The subject is capable of giving informed consent Subject is willing to sign a consent form Adult male or female ≥ 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 the 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 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 chronic disease (either acute or chronic) 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 Treatment with antibiotics with in 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 History of acute necrotizing ulcerative gingivitis 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

Sites / Locations

  • UCL Eastman Dental Institute

Outcomes

Primary Outcome Measures

Decrease in Periodontal Pocket Depth

Secondary Outcome Measures

Reduction in Bleeding on Probing
Increase in Clinical Attachment Level

Full Information

First Posted
February 23, 2006
Last Updated
May 17, 2007
Sponsor
Ondine Research Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00296881
Brief Title
SRP in Combination With PERIOWAVE in Comparison to SRP Alone in Chronic Periodontitis
Official Title
Clinical Outcomes Following Non-Surgical Treatment of Chronic Periodontitis, Using Scaling and Root Planing (SRP) in Conjunction With PerioWave, Compared to SRP Alone
Study Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Unknown status
Study Start Date
April 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (Anticipated)

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
Periodontitis, Photodynamic Disinfection, PERIOWAVE, Scaling and Root Planing, SRP

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
PERIOWAVE
Primary Outcome Measure Information:
Title
Decrease in Periodontal Pocket Depth
Time Frame
6, 12, 24, 36, 48 weeks
Secondary Outcome Measure Information:
Title
Reduction in Bleeding on Probing
Time Frame
6, 12, 24, 36, 48 weeks
Title
Increase in Clinical Attachment Level
Time Frame
6, 12, 24, 36, 48 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 Subject is willing to sign a consent form Adult male or female ≥ 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 the 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 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 chronic disease (either acute or chronic) 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 Treatment with antibiotics with in 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 History of acute necrotizing ulcerative gingivitis 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nikos Donos, DDS, MS, PhD
Organizational Affiliation
University College London, Eastman Dental Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCL Eastman Dental Institute
City
London
ZIP/Postal Code
WC1X 8LD
Country
United Kingdom

12. IPD Sharing Statement

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SRP in Combination With PERIOWAVE in Comparison to SRP Alone in Chronic Periodontitis

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