Herbal Periodontal Patch (THPP) for Gingival Inflammation in Diabetics

• Status: Suspended
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Izun Pharma Ltd

Criteria

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