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Herbal Periodontal Patch (THPP) for Gingival Inflammation in Diabetics

NCT00731432 · Status: SUSPENDED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2011-07-20

No results posted yet for this study

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

DRUG

Transmucosal Herbal Periodontal Patch (THPP)

Patch applied to oral gingiva

DRUG

Placebo Patch

Identical in shape and texture to treatment patch

Sponsors & Collaborators

  • Izun Pharma Ltd

    lead INDUSTRY

Principal Investigators

  • Oded Yaniv, DMD · Izun Pharma Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00731432 on ClinicalTrials.gov