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The Efficacy and Safety of PerioChip Plus (Flurbiprofen/Chlorhexidine) Formulation in the Therapy of Adult Periodontitis

This study is not yet open for participant recruitment.
Verified by Dexcel Pharma Technologies Ltd., January 2007

Sponsored by: Dexcel Pharma Technologies Ltd.
Information provided by: Dexcel Pharma Technologies Ltd.
ClinicalTrials.gov Identifier: NCT00425451
  Purpose

To determine the effect of the placement of a PerioChip Plus (flurbiprofen/chlorhexidine - FBP/CHX) formulation versus PerioChip (chlorhexidine) formulation versus Flurbiprofen Chip formulation versus Placebo Chip formulation on probing pocket depth (PPD)


Condition Intervention Phase
Periodontitis
Drug: flurbiprofen/chlorhexidine
Phase II

ChemIDplus related topics:   Chlorhexidine    Chlorhexidine digluconate    Flurbiprofen    Flurbiprofen sodium   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title:   The Efficacy and Safety of PerioChip Plus (Flurbiprofen/Chlorhexidine) Formulation in the Therapy of Adult Periodontitis

Further study details as provided by Dexcel Pharma Technologies Ltd.:

Primary Outcome Measures:
  • At 24 weeks, relative to baseline, the mean reductions in probing pocket depth (PPD) will be used as primary efficacy endpoint. Additional primary endpoints are clinical attachment levels (CAL) and bleeding on probing (BOP) in the target pockets selected

Secondary Outcome Measures:
  • PPD measurements at 6, 12 and 18 weeks will be used as secondary endpoints. Additional secondary endpoints are clinical attachment levels (CAL) and bleeding on probing (BOP) in the target pockets selected at screening, measured at weeks 6, 12 and 18.

Estimated Enrollment:   80

Detailed Description:

This is an 80 subjects, single-center, randomized, double-blinded, parallel, 4-arm clinical study (25 subjects in the PerioChip Plus and PerioChip arms and 15 subjects in the Flurbiprofen Chip and Placebo Chip arms).

At 24 weeks, relative to baseline, the mean reductions in probing pocket depth (PPD) will be used as primary efficacy endpoint. Additional primary endpoints are clinical attachment levels (CAL) and bleeding on probing (BOP) in the target pockets selected at screening, measured at weeks 24.

PPD measurements at 6, 12 and 18 weeks will be used as secondary endpoints. Additional secondary endpoints are clinical attachment levels (CAL) and bleeding on probing (BOP) in the target pockets selected at screening, measured at weeks 6, 12 and 18.

  Eligibility
Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Signed informed consent form
  • Good general health
  • Male or female subjects aged >25 years old
  • Minimum of 8 natural teeth
  • Availability for the 25 weeks duration of the study
  • Periodontal disease on a natural teeth characterized by the presence of at least 2 teeth with periodontal pockets of 6-9 mm in depth (target teeth) in order to reach baseline (day 1) with periodontal pockets of 5-8 mm in depth, without involving the apex of the tooth.
  • Females of childbearing potential must be non pregnant at entry and agree to use an adequate method of birth control during the study.
  • Demonstrate bleeding on probing to the base of the pocket at the pockets (sites) selected at the time of screening.

Exclusion Criteria:

  • Presence of oral local mechanical factors that could (in the opinion of the investigator) influences the outcome of the study.
  • Presence of orthodontic appliances or any removable appliance that impinges on the tissues being assessed.
  • Soft or hard tissue tumours of the oral cavity.
  • Presence of dental implant adjacent to target tooth.
  • Periodontal pockets of more than 9 mm in depth.
  • General systemic antibiotics therapy or periodontal/mechanical/local delivery therapy within 6 weeks prior to study entry and through out the study duration.
  • History of allergy to chlorhexidine, flurbiprofen or to other non-steroidal anti-inflammatory drugs (NSAIDs).
  • Subjects taking diphenylhydantoin, nifedepine and/or cyclosporine, which might influence the pattern of tissue response.
  • Subject treated with non-steroidal anti-inflammatory drugs (NSAIDs) within 14 days prior to entry into the study and through out the study duration.
  • Pregnant women or those planning to become pregnant or lactating women.
  • Presence of the following conditions: Type 1 diabetes, major recurrent aphtae, stomatitis and related oral pathologies.
  • The presence of any medical or psychiatric condition or any other condition that in the opinion of the investigator could affect the successful participation of the subject in the study.
  • Subject participates in any other clinical study 30 days prior to the start of the study and through out the study duration.
  • Subject uses chlorhexidine oral rinses/ mouthwashes on a regular basis.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00425451

Contacts
Contact: Aubrey Soskolne, Professor     972-2-6777826     sosko@cc.huji.ac.il    
Contact: Avi Avramoff, M.Ph     972-4-6364003     Avi.Avramoff@dexxon.co.il    

Locations
Israel
Hadassah Medical Organization     Not yet recruiting
      Jerusalem, Israel, 91120
      Principal Investigator: Aubrey Soskolne, Professor            

Sponsors and Collaborators
Dexcel Pharma Technologies Ltd.

Investigators
Principal Investigator:     Aubrey Soskolne, Professor     Hadassah Medical Organization IRB    
  More Information


Study ID Numbers:   CLI/006P
First Received:   January 21, 2007
Last Updated:   January 21, 2007
ClinicalTrials.gov Identifier:   NCT00425451
Health Authority:   Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Dexcel Pharma Technologies Ltd.:
Periodontitis  
Dental Care  
Efficacy  
Safety  

Study placed in the following topic categories:
Mouth Diseases
Periodontal Diseases
Chlorhexidine
Flurbiprofen
Chlorhexidine gluconate
Periodontitis
Stomatognathic Diseases

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Enzyme Inhibitors
Pharmacologic Actions
Anti-Infective Agents, Local
Disinfectants
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on October 03, 2008




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