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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00336661
Recruitment Status : Completed
First Posted : June 14, 2006
Last Update Posted : May 21, 2007
Loma Linda University
Information provided by:
Ondine Research Laboratories

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.

Condition or disease Intervention/treatment Phase
Periodontitis Device: PerioWave Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
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 Start Date : January 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Improvement in Clinical Attachment Level [ Time Frame: 12-weeks ]

Secondary Outcome Measures :
  1. Improvement in Periodontal Pocket Depth [ Time Frame: 12-weeks ]
  2. Improvement in Bleeding on Probing [ Time Frame: 12-weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. The subject is capable of giving informed consent
  2. The subject is willing to sign a consent form
  3. The subject is an adult male or female > 18
  4. The subject is diagnosed with chronic periodontitis
  5. The subject has >18 fully erupted teeth
  6. The subject has at least 4 measurement sites with pocket depth of 6-9 mm in at least two quadrants of the mouth.
  7. Subject is willing and able to return for treatment and evaluation procedures scheduled throughout the course of this clinical study

Exclusion Criteria:

  1. The subject is pregnant or nursing or who plans to become pregnant in the next 4 months
  2. The subject has significant liver disease by subject report
  3. The subject has an active malignancy of any type by subject report
  4. The subject has chronic disease or diminished mental capacity that would mitigate the ability to comply with the protocol
  5. 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®
  6. The subject has an active periapical abscess or periodontal abscess or a history of acute necrotizing ulcerative gingivitis
  7. 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
  8. The subject has a known allergy to Methylene Blue
  9. Has glucose-6-phosphate dehydrogenase (G6PD) deficiency by subject report
  10. The subject currently uses anti-coagulant therapy at therapeutic doses
  11. The subject is currently using any photosensitizing medications
  12. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00336661

Shanghai Second Medical University
Shanghai, China
Wenzhou Hospital Department of Dentistry
Wenzhou, China
Sponsors and Collaborators
Ondine Research Laboratories
Loma Linda University
Principal Investigator: Rong Shu Shanghai Second Medical University
Principal Investigator: Hu Zhong Wenzhou Hospital Department of Dentistry

Publications: Identifier: NCT00336661     History of Changes
Other Study ID Numbers: ORL-0605-2
First Posted: June 14, 2006    Key Record Dates
Last Update Posted: May 21, 2007
Last Verified: May 2007

Keywords provided by Ondine Research Laboratories:
Chronic Periodontitis
Photodynamic Disinfection

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