Herbal Periodontal Patch (THPP) for Gingival Inflammation in Diabetics

NCT00731432 | Suspended Phase 2

• 1 other identifier: C-3
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingival Inflammation in Diabetic Patients

Keywords

gingivitis, diabetes mellitus, herbal, oral inflammation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

A

EXPERIMENTAL

Transmucosal Herbal Periodontal Patch (THPP)

Drug: Transmucosal Herbal Periodontal Patch (THPP)

B

PLACEBO COMPARATOR

Placebo Patch

Drug: Placebo Patch

Interventions

Transmucosal Herbal Periodontal Patch (THPP) DRUG

Patch applied to oral gingiva

Also known as: Day 1: 1 patch X 3/d, Day 2-3: 1 patch X1/d, Days 4-5: no patch

A

Placebo Patch DRUG

Identical in shape and texture to treatment patch

Also known as: Day 1: 1 patch X 3/d, Day 2-3: 1 patch X1/d, Days 4-5: no patch

B

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Allergy to any herbal medications
• Pregnancy or lactation
• Periodontal treatment in the last three months

Sponsors & Collaborators

• Izun Pharma Ltd: lead

Study Sites (1)

Herzog Hospital

Jerusalem, 91035, Israel

Location

MeSH Terms

Conditions

Gingivitis; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Oded Yaniv, DMD

  Izun Pharma Limited

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 7, 2008
• First Posted: August 11, 2008
• Study Start: August 1, 2008
• Last Updated: July 20, 2011

Record last verified: 2008-08

Locations

IL (1)