The Efficacy and Safety of PerioChip Plus (Flurbiprofen/Chlorhexidine) Formulation in the Therapy of Adult Periodontitis
Information source: Dexcel Pharma Technologies Ltd.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Periodontitis
Intervention: PerioChip Plus (Flurbiprofen +Chlorhexidine ), Flurbiprofen Chip, PerioChip (Chlorhexidine ) and Placebo Chip (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Dexcel Pharma Technologies Ltd. Official(s) and/or principal investigator(s): Aubrey Soskolne, Professor, Principal Investigator, Affiliation: Hadassah Medical Organization IRB
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)
Clinical Details
Official title: The Efficacy and Safety of PerioChip Plus (Flurbiprofen/Chlorhexidine) Formulation in the Therapy of Adult Periodontitis
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: 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
Secondary outcome: 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.
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
Minimum age: 25 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Hadassah Medical Organization, Jerusalem 91120, Israel
Additional Information
Starting date: August 2008
Last updated: June 13, 2011
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