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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | January 21, 2007 | ||||
| Last Updated Date | December 28, 2009 | ||||
| Start Date ICMJE | August 2008 | ||||
| Primary Completion Date | January 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00425451 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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. | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Efficacy and Safety of PerioChip Plus (Flurbiprofen/Chlorhexidine) Formulation in the Therapy of Adult Periodontitis | ||||
| Official Title ICMJE | The Efficacy and Safety of PerioChip Plus (Flurbiprofen/Chlorhexidine) Formulation in the Therapy of Adult Periodontitis | ||||
| 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 Flurbiprofen Chip formulation versus Placebo Chip formulation on probing pocket depth (PPD) |
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| 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. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Allocation: Randomized Control: Active Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Periodontitis | ||||
| Intervention ICMJE | Drug: flurbiprofen/chlorhexidine | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 80 | ||||
| Completion Date | March 2009 | ||||
| Primary Completion Date | January 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 25 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00425451 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CLI/006P | ||||
| Study Sponsor ICMJE | Dexcel Pharma Technologies Ltd. | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Dexcel Pharma Technologies Ltd. | ||||
| Verification Date | August 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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