Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00425451
Status:
COMPLETED
Last Update Posted:
2011-06-14
First Post:
2007-01-21
Brief Title:
The Efficacy and Safety of PerioChip Plus FlurbiprofenChlorhexidine Formulation in the Therapy of Adult Periodontitis
Sponsor:
Dexcel Pharma Technologies Ltd
Organization:
Dexcel Pharma Technologies Ltd
Study Overview
Official Title:
The Efficacy and Safety of PerioChip Plus FlurbiprofenChlorhexidine Formulation in the Therapy of Adult Periodontitis
Status:
COMPLETED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the effect of the placement of a PerioChip Plus flurbiprofenchlorhexidine - FBPCHX formulation versus PerioChip chlorhexidine formulation versus Flurbiprofen Chip formulation versus Placebo Chip formulation on probing pocket depth PPD
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None