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

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ClinicalTrials.gov Identifier: NCT00425451
Recruitment Status : Completed
First Posted : January 23, 2007
Last Update Posted : June 14, 2011
Sponsor:
Information provided by:
Dexcel Pharma Technologies Ltd.

Study Description
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Brief Summary:
The purpose of this study is 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 or disease Intervention/treatment Phase
Periodontitis Drug: PerioChip Plus (Flurbiprofen +Chlorhexidine ), Flurbiprofen Chip, PerioChip (Chlorhexidine ) and Placebo Chip Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of PerioChip Plus (Flurbiprofen/Chlorhexidine) Formulation in the Therapy of Adult Periodontitis
Study Start Date : August 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : March 2009

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Arms and Interventions
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Arm Intervention/treatment
Experimental: PerioChip Plus Drug: PerioChip Plus (Flurbiprofen +Chlorhexidine ), Flurbiprofen Chip, PerioChip (Chlorhexidine ) and Placebo Chip
Experimental: Flurbiprofen Chip Drug: PerioChip Plus (Flurbiprofen +Chlorhexidine ), Flurbiprofen Chip, PerioChip (Chlorhexidine ) and Placebo Chip
Active Comparator: PerioChip Drug: PerioChip Plus (Flurbiprofen +Chlorhexidine ), Flurbiprofen Chip, PerioChip (Chlorhexidine ) and Placebo Chip
Placebo Comparator: Placebo Chip Drug: PerioChip Plus (Flurbiprofen +Chlorhexidine ), Flurbiprofen Chip, PerioChip (Chlorhexidine ) and Placebo Chip


Outcome Measures
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Primary Outcome Measures :
  1. 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 [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: 24 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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 ClinicalTrials.gov identifier (NCT number): NCT00425451


Locations
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Israel
Hadassah Medical Organization
Jerusalem, Israel, 91120
Sponsors and Collaborators
Dexcel Pharma Technologies Ltd.
Investigators
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Principal Investigator: Aubrey Soskolne, Professor Hadassah Medical Organization IRB
More Information
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Responsible Party: Dr. Avi Avramoof/ V.P R&D, Dexcel Pharma Technologies Ltd.
ClinicalTrials.gov Identifier: NCT00425451    
Other Study ID Numbers: CLI/006P
First Posted: January 23, 2007    Key Record Dates
Last Update Posted: June 14, 2011
Last Verified: June 2011
Keywords provided by Dexcel Pharma Technologies Ltd.:
Periodontitis
Dental Care
Efficacy
Safety
Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Chlorhexidine
Chlorhexidine gluconate
Flurbiprofen
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action