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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by Ondine Research Laboratories.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Ondine Research Laboratories
ClinicalTrials.gov Identifier:
NCT00296881
First received: February 23, 2006
Last updated: May 17, 2007
Last verified: May 2007
History of Changes
  Purpose

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 Intervention Phase
Periodontitis
 Device: PERIOWAVE
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ondine Research Laboratories:

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

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

Enrollment: 80
Study Start Date: April 2006
Estimated Study Completion Date: December 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00296881

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

Publications:

ClinicalTrials.gov Identifier: NCT00296881     History of Changes
Other Study ID Numbers: ORL-0605-3
Study First Received: February 23, 2006
Last Updated: May 17, 2007
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Ondine Research Laboratories:
Periodontitis
Photodynamic Disinfection
PERIOWAVE
Scaling and Root Planing
SRP

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

ClinicalTrials.gov processed this record on June 18, 2013