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Herbal Periodontal Patch (THPP) for Gingival Inflammation in Diabetics

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ClinicalTrials.gov Identifier: NCT00731432
Recruitment Status : Suspended (Failure to recruit)
First Posted : August 11, 2008
Last Update Posted : July 20, 2011
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Gingival Inflammation in Diabetic Patients Drug: Transmucosal Herbal Periodontal Patch (THPP) Drug: Placebo Patch Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Effect Of A Transmucosal Herbal Periodontal Patch (THPP) on Gingival Inflammation in Diabetic Patients
Study Start Date : August 2008

Arm Intervention/treatment
Experimental: A
Transmucosal Herbal Periodontal Patch (THPP)
Drug: Transmucosal Herbal Periodontal Patch (THPP)
Patch applied to oral gingiva
Other Names:
  • Day 1: 1 patch X 3/d
  • Day 2-3: 1 patch X1/d
  • Days 4-5: no patch
Placebo Comparator: B
Placebo Patch
Drug: Placebo Patch
Identical in shape and texture to treatment patch
Other Names:
  • Day 1: 1 patch X 3/d
  • Day 2-3: 1 patch X1/d
  • Days 4-5: no patch

Primary Outcome Measures :
  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 [ Time Frame: 5 days ]

Secondary Outcome Measures :
  1. frequency and severity of any adverse event [ Time Frame: 5 days ]
  2. 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. [ Time Frame: 5 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00731432

Herzog Hospital
Jerusalem, Israel, 91035
Sponsors and Collaborators
Izun Pharma Ltd
Principal Investigator: Oded Yaniv, DMD Izun Pharma Limited

Responsible Party: Dr. Y. Caine, Herzog Hospital, Jerusalem, Israel
ClinicalTrials.gov Identifier: NCT00731432     History of Changes
Other Study ID Numbers: C-3
First Posted: August 11, 2008    Key Record Dates
Last Update Posted: July 20, 2011
Last Verified: August 2008

Keywords provided by Izun Pharma Ltd:
gingivitis, diabetes mellitus, herbal, oral inflammation

Additional relevant MeSH terms:
Pathologic Processes
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases