Effect of Herbal Extracts on Gingival Inflammation
Phase 2
Completed
- Conditions
- Gingivitis
- Registration Number
- NCT00554034
- Lead Sponsor
- Shaare Zedek Medical Center
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- Age 18 -75.
- Severe localized gingival inflammation [GI index 2 or greater
Exclusion Criteria
- Pregnancy or a wish to become pregnant during the study.
- History of periodontal treatment within the last month.
- Antibiotic treatment within the last month
- Use of any antimicrobial mouthrinse within the last month.
- Participation in another trial one month prior to the study.
- Inability to behave compliant to the trial protocol by not placing all the patches given, or attending scheduled appointments.
- Systemic Disease.
- Patients using salicylate
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To determine the correct dosing of the herbal Patch [THPP] 3 months
- Secondary Outcome Measures
Name Time Method To demonstarte the safety of THPP on the gingival tissue and in the oral cavity 3 months
Trial Locations
- Locations (1)
Jerusalem Perio Center
🇮🇱Jerusalem, Israel