Effect of Herbal Extracts on Gingival Inflammation

Shaare Zedek Medical Center

Status and phase: Completed; Phase 2

Conditions: Gingivitis

Treatments: Drug: periopatch

Study type: Interventional

Funder types: Other

Identifiers

NCT00554034

Protocol C-4

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age 18 -75.
2. Severe localized gingival inflammation [GI index 2 or greater

Exclusion criteria

1. Pregnancy or a wish to become pregnant during the study.
2. History of periodontal treatment within the last month.
3. Antibiotic treatment within the last month
4. Use of any antimicrobial mouthrinse within the last month.
5. Participation in another trial one month prior to the study.
6. Inability to behave compliant to the trial protocol by not placing all the patches given, or attending scheduled appointments.
7. Systemic Disease.
8. Patients using salicylate

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)