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

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

Purpose

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	Intervention	Phase
Periodontitis	Drug: PerioChip Plus (Flurbiprofen +Chlorhexidine ), Flurbiprofen Chip, PerioChip (Chlorhexidine ) and Placebo Chip	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	The Efficacy and Safety of PerioChip Plus (Flurbiprofen/Chlorhexidine) Formulation in the Therapy of Adult Periodontitis

Resource links provided by NLM:

Drug Information available for: Chlorhexidine Flurbiprofen Chlorhexidine gluconate Flurbiprofen sodium Hibiclens

U.S. FDA Resources

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 [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

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. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	80
Study Start Date:	August 2008
Study Completion Date:	March 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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

Locations

Israel
Hadassah Medical Organization
Jerusalem, Israel, 91120

Sponsors and Collaborators

Dexcel Pharma Technologies Ltd.

Investigators

Principal Investigator:

Aubrey Soskolne, Professor

Hadassah Medical Organization IRB

More Information

No publications provided

Responsible Party:	Dr. Avi Avramoof/ V.P R&D, Dexcel Pharma Technologies Ltd.
ClinicalTrials.gov Identifier:	NCT00425451 History of Changes
Other Study ID Numbers:	CLI/006P
Study First Received:	January 21, 2007
Last Updated:	June 13, 2011
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Dexcel Pharma Technologies Ltd.:

Periodontitis
Dental Care
Efficacy
Safety

Additional relevant MeSH terms:

Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Chlorhexidine
Chlorhexidine gluconate
Flurbiprofen
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants

Dermatologic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 22, 2012