drugset / Trial / NCT00554034

Effect of Herbal Extracts on Gingival Inflammation

NCT00554034 ↗

Phase 2 Completed 60 enrolled Shaare Zedek Medical Center
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2007-11
Primary completion
2009-03
Completion
2009-03

Drugs

EvaluationDrugModalityDoseRoute
Subject periopatch Unknown 1 unknown —
Subject periopatch Unknown 2 unknown —
Subject periopatch Unknown 3 unknown —
Subject periopatch Unknown 4 unknown —

Indications