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

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dexcel Pharma Technologies Ltd.
• Treatments: Chlorhexidine; Chlorhexidine gluconate; Flurbiprofen

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.