Gingival Inflammation in Diabetic Patients Clinical Trial
Official title:
The Effect Of A Transmucosal Herbal Periodontal Patch (THPP) on Gingival Inflammation in Diabetic Patients
| NCT number | NCT00731432 |
| Other study ID # | C-3 |
| Secondary ID | |
| Status | Suspended |
| Phase | Phase 2 |
| First received | August 7, 2008 |
| Last updated | July 19, 2011 |
| Start date | August 2008 |
Diabetes increases the incidence and severity of periodontal inflammation and disease, and periodontal disease causes an increase in the severity of diabetes by worsening glycemic control and increasing insulin resistance.The Transmucosal Herbal Periodontal Patch (THPP) is a transmucosal patch containing an herbal compound that has an anti-inflammatory effect on gingival tissue.The primary objective of this study is to determine the efficacy of the Transmucosal Herbal Periodontal Patch (THPP) compared with placebo patch (PP) in reducing gingival inflammation at the site of placement in diabetic patients. We also aim to determine if the THPP decreases gingival inflammation throughout the mouth and the safety of THPP compared with placebo patch when applied to the mucosa in the treatment of gingival inflammation in diabetic patients.
| Status | Suspended |
| Enrollment | 60 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 85 Years |
| Eligibility |
Inclusion Criteria: - Male and female patients between the ages of 18 and 85 years - Patients must have a minimum of 3 posterior teeth in all quadrants - A mean gingival index (GI) of >1.5 on the posterior teeth - Diagnosis of Diabetes type 1 or 2, adequately controlled by diet and/or medications, as determined by the patient's physician Exclusion Criteria: - Allergy to any herbal medications - Pregnancy or lactation - Periodontal treatment in the last three months |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Israel | Herzog Hospital | Jerusalem |
| Lead Sponsor | Collaborator |
|---|---|
| Izun Pharma Ltd |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The primary endpoint of the study will be the comparison between THPP and PP in reducing the gingival index (GI) at the site of patch placement | 5 days | No | |
| Secondary | frequency and severity of any adverse event | 5 days | Yes | |
| Secondary | Beta-glucuronidase enzyme found in gingival crevicular fluid (GCF) of the tested sites. The GCF will be collected from the second most posterior tooth in all four quadrants. | 5 days | No |