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Sponsored by: |
Dexcel Pharma Technologies Ltd. |
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Information provided by: | Dexcel Pharma Technologies Ltd. |
ClinicalTrials.gov Identifier: | NCT00425451 |
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 |
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Periodontitis |
Drug: flurbiprofen/chlorhexidine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | The Efficacy and Safety of PerioChip Plus (Flurbiprofen/Chlorhexidine) Formulation in the Therapy of Adult Periodontitis |
Estimated Enrollment: | 80 |
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.
Ages Eligible for Study: | 25 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Aubrey Soskolne, Professor | 972-2-6777826 | sosko@cc.huji.ac.il |
Contact: Avi Avramoff, M.Ph | 972-4-6364003 | Avi.Avramoff@dexxon.co.il |
Israel | |
Hadassah Medical Organization | |
Jerusalem, Israel, 91120 |
Principal Investigator: | Aubrey Soskolne, Professor | Hadassah Medical Organization IRB |
Study ID Numbers: | CLI/006P |
Study First Received: | January 21, 2007 |
Last Updated: | January 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00425451 |
Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Periodontitis Dental Care Efficacy Safety |
Mouth Diseases Periodontal Diseases Chlorhexidine Flurbiprofen |
Chlorhexidine gluconate Periodontitis Stomatognathic Diseases |
Anti-Inflammatory Agents Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Cyclooxygenase Inhibitors Physiological Effects of Drugs Enzyme Inhibitors Pharmacologic Actions Anti-Infective Agents, Local Disinfectants |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents Dermatologic Agents |