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

This study is ongoing, but not recruiting participants.
Information provided by Ondine Research Laboratories

This Tabular View shows the required WHO registration data elements as marked by

Descriptive Information Fields
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
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.

Study Phase Phase IV
Study Type  Interventional
Study Design  Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure  Decrease in Periodontal Pocket Depth [ Time Frame: 6, 12, 24, 36, 48 weeks ]
Secondary Outcome Measure  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 ]
Condition  Periodontitis
Intervention  Device: PERIOWAVE
MEDLINE PMIDs 10052767,   12102710,   10052768,   11324049,   9673160,   9673164,   9118258,   9118283,   9126183,   11128918,   11327066,   9673166,   8393109,   12472990,   6384275,   8473536,   1452806,   6957591,   2204636,   2213468,   9350562,   12436823,   12787214,   11895543,   1369193,   2115912,   3522156,   1334649,   8233573,   2276829,   8388448,   9747591,   1159805,   1322699,   8373789,   7899497,   7506775,   9745730,   8884652,   10738296,   14704501,   12962360,   9700525,   3327061,   11391471
Links
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment  80
Start Date  April 2006
Completion Date December 2007
Eligibility 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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United Kingdom
Administrative Information Fields
NCT ID  NCT00296881
Organization ID ORL-0605-3
Secondary IDs ††
Study Sponsor  Ondine Research Laboratories
Collaborators ††
Investigators 
Principal Investigator:     Nikos Donos, DDS, MS, PhD     University College London, Eastman Dental Institute    
Information Provided By Ondine Research Laboratories
Verification Date May 2007
First Received Date  February 23, 2006
Last Updated Date May 17, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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