Herbal Periodontal Patch (THPP) for Gingival Inflammation in Diabetics

Phase 2

Suspended

• Conditions: Gingival Inflammation in Diabetic Patients
• Interventions: Drug: Placebo Patch; Drug: Transmucosal Herbal Periodontal Patch (THPP)

• Registration Number: NCT00731432
• Lead Sponsor: Izun Pharma Ltd

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-08
• Study Start: 2008-08
• Study First Submitted: 2008-08-07
• Study First Submitted QC: 2008-08-08
• Study First Posted: 2008-08-11
• Last Update Submitted: 2011-07-19
• Last Update Posted: 2011-07-20

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Placebo Patch	Placebo Patch
A	Transmucosal Herbal Periodontal Patch (THPP)	Transmucosal Herbal Periodontal Patch (THPP)

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
frequency and severity of any adverse event	5 days
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

Trial Locations

Locations (1)

Herzog Hospital; 🇮🇱 Jerusalem, Israel