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

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)

Study Overview

• Status: Completed
• Conditions: Periodontitis
• Intervention / Treatment: 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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel, 91120
    • Hadassah Medical Organization

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 23 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	24 weeks

Collaborators and Investigators

• Sponsor: Dexcel Pharma Technologies Ltd.
• Investigators: Principal Investigator: Aubrey Soskolne, Professor, Hadassah Medical Organization IRB

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: January 21, 2007
• First Submitted That Met QC Criteria: January 21, 2007
• First Posted (Estimate): January 23, 2007

Study Record Updates

• Last Update Posted (Estimate): June 14, 2011
• Last Update Submitted That Met QC Criteria: June 13, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: Safety; Efficacy; Periodontitis; Dental Care
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Dermatologic Agents; Disinfectants; Chlorhexidine; Chlorhexidine gluconate; Flurbiprofen
• Other Study ID Numbers: CLI/006P