Herbal Periodontal Patch (THPP) for Gingival Inflammation in Diabetics

NCT ID: NCT00731432

Last Updated: 2011-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Brief Summary

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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

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Conditions

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Gingival Inflammation in Diabetic Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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A

Transmucosal Herbal Periodontal Patch (THPP)

Group Type EXPERIMENTAL

Transmucosal Herbal Periodontal Patch (THPP)

Intervention Type DRUG

Patch applied to oral gingiva

B

Placebo Patch

Group Type PLACEBO_COMPARATOR

Placebo Patch

Intervention Type DRUG

Identical in shape and texture to treatment patch

Interventions

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Transmucosal Herbal Periodontal Patch (THPP)

Patch applied to oral gingiva

Intervention Type DRUG

Placebo Patch

Identical in shape and texture to treatment patch

Intervention Type DRUG

Other Intervention Names

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Day 1: 1 patch X 3/d Day 2-3: 1 patch X1/d Days 4-5: no patch Day 1: 1 patch X 3/d Day 2-3: 1 patch X1/d Days 4-5: no patch

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Izun Pharma Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Herzog Hospital, Jerusalem, Israel

Principal Investigators

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Oded Yaniv, DMD

Role: PRINCIPAL_INVESTIGATOR

Izun Pharma Limited

Locations

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Herzog Hospital

Jerusalem, , Israel

Site Status

Countries

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Israel

Other Identifiers

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C-3

Identifier Type: -

Identifier Source: org_study_id

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