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

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: NCT00296881
Recruitment Status : Unknown
Verified May 2007 by Ondine Research Laboratories.
Recruitment status was:  Active, not recruiting
First Posted : February 27, 2006
Last Update Posted : May 21, 2007
Information provided by:
Ondine Research Laboratories

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.

Condition or disease Intervention/treatment Phase
Periodontitis Device: PERIOWAVE Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
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 Start Date : April 2006
Estimated Study Completion Date : December 2007

Primary Outcome Measures :
  1. Decrease in Periodontal Pocket Depth [ Time Frame: 6, 12, 24, 36, 48 weeks ]

Secondary Outcome Measures :
  1. Reduction in Bleeding on Probing [ Time Frame: 6, 12, 24, 36, 48 weeks ]
  2. Increase in Clinical Attachment Level [ Time Frame: 6, 12, 24, 36, 48 weeks ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. The subject is capable of giving informed consent
  2. Subject is willing to sign a consent form
  3. Adult male or female ≥ the age of 18
  4. Having been diagnosed with chronic periodontitis
  5. >18 fully erupted teeth
  6. Has had no periodontal instrumentation in the four months prior to the initiation of study treatment
  7. Subject has at least 4 sites with pocket depth of 6-9 mm in at least two quadrants of the mouth.
  8. Subject is willing and able to return for treatment and evaluation procedures scheduled throughout the course of this clinical study

Exclusion Criteria:

  1. Is pregnant or nursing or who plans to become pregnant in the next 4 months
  2. Having significant liver disease by subject report
  3. Having an active malignancy of any type by subject report
  4. Having chronic disease or diminished mental capacity that would mitigate the ability to comply with the protocol
  5. 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®
  6. Having an active periapical abscess or periodontal abscess
  7. 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
  8. History of acute necrotizing ulcerative gingivitis
  9. Known allergy to Methylene Blue
  10. Has glucose-6-phosphate dehydrogenase (G6PD) deficiency by subject report
  11. Currently uses anti-coagulant therapy at therapeutic doses
  12. Currently uses photosensitizing medications
  13. Participated in investigational treatment in the last 30 days or 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): NCT00296881

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United Kingdom
UCL Eastman Dental Institute
London, United Kingdom, WC1X 8LD
Sponsors and Collaborators
Ondine Research Laboratories
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Principal Investigator: Nikos Donos, DDS, MS, PhD University College London, Eastman Dental Institute

Layout table for additonal information Identifier: NCT00296881    
Other Study ID Numbers: ORL-0605-3
First Posted: February 27, 2006    Key Record Dates
Last Update Posted: May 21, 2007
Last Verified: May 2007
Keywords provided by Ondine Research Laboratories:
Photodynamic Disinfection
Scaling and Root Planing
Additional relevant MeSH terms:
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Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases