Status:
COMPLETED
The Efficacy and Safety of PerioChip Plus (Flurbiprofen/Chlorhexidine) Formulation in the Therapy of Adult Periodontitis
Lead Sponsor:
Dexcel Pharma Technologies Ltd.
Conditions:
Periodontitis
Eligibility:
All Genders
25+ years
Phase:
PHASE2
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 Flurbip...
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 Pla...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00425451
Start Date
August 1 2008
End Date
March 1 2009
Last Update
June 14 2011
Active Locations (1)
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1
Hadassah Medical Organization
Jerusalem, Israel, 91120