Herbal Periodontal Patch (THPP) for Gingival Inflammation in Diabetics

Izun Pharma

Status and phase

Suspended

Phase 2

Conditions

Gingival Inflammation in Diabetic Patients

Treatments

Drug: Placebo Patch

Drug: Transmucosal Herbal Periodontal Patch (THPP)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00731432

C-3

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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