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NCT00554034

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

Completed Phase 2 Last updated 19 December 2010
What this trial tests

Phase 2 trial testing periopatch in Gingivitis in 60 participants. Completed in 1 March 2009.

Timeline
1 November 2007
Primary endpoint
1 March 2009
1 March 2009

Quick facts

Lead sponsorShaare Zedek Medical Center
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment60
Start date1 November 2007
Primary completion1 March 2009
Estimated completion1 March 2009
Sites1 location across Israel

Drugs / interventions tested

Conditions studied

Sponsor

Shaare Zedek Medical Center

Who can join

Adults 18 to 75, any sex, with Gingivitis. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Gingivitis

Currently open trials in the same condition.

Other Shaare Zedek Medical Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00554034.

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