NCT00554034

Effect of Herbal Extracts on Gingival Inflammation

The Effect of Herbal Extracts on Inflammatory Enzymes in the Gingiva: a Dose Finding Study.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Shaare Zedek Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the minimal number of patches needed to get an effective response. Patients enrolled in the study will be given 1, 2, 3 or 4 patches in a cycle by the order they enter the study. After the first 20 patients \[5 cycles\], the effect of the number of patches will be tested. If there is no distinct reduction of beta glucuronidase in the GCF or of gingival index at the tested sites, more patients will be enrolled. Patients will be added one cycle at a time with results being tested and analyzed. The enrollemnts of patients will stop when a dose response will be noticed or 15 cycles have been reached.

Conditions

• Gingivitis

Interventions

Type	Name	Description
DRUG	periopatch	Patients enrolled in the study will be given 1, 2, 3 or 4 patches in a cycle by the order they enter the study.

Timeline

• Start date: 2007-11-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2007-11-06
• Last updated: 2010-12-21

Locations

1 site across 1 country: Israel