NCT00731432

Herbal Periodontal Patch (THPP) for Gingival Inflammation in Diabetics

The Effect Of A Transmucosal Herbal Periodontal Patch (THPP) on Gingival Inflammation in Diabetic Patients

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Izun Pharma Ltd · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gingival Inflammation in Diabetic Patients

Interventions

Type	Name	Description
DRUG	Transmucosal Herbal Periodontal Patch (THPP)	Patch applied to oral gingiva
DRUG	Placebo Patch	Identical in shape and texture to treatment patch

Timeline

• Start date: 2008-08-01
• First posted: 2008-08-11
• Last updated: 2011-07-20

Locations

1 site across 1 country: Israel