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Herbal Periodontal Patch (THPP) for Gingival Inflammation in Diabetics

This study has suspended participant recruitment.
(Failure to recruit)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00731432
First Posted: August 11, 2008
Last Update Posted: July 20, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Izun Pharma Ltd
  Purpose
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 Intervention Phase
Gingival Inflammation in Diabetic Patients Drug: Transmucosal Herbal Periodontal Patch (THPP) Drug: Placebo Patch Phase 2

Study Type: Interventional
Study Design: 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

Further study details as provided by Izun Pharma Ltd:

Primary Outcome Measures:
  • 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:
  • frequency and severity of any adverse event [ Time Frame: 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. [ Time Frame: 5 days ]

Estimated Enrollment: 60
Study Start Date: August 2008
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
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


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

Responsible Party: Dr. Y. Caine, Herzog Hospital, Jerusalem, Israel
ClinicalTrials.gov Identifier: NCT00731432     History of Changes
Other Study ID Numbers: C-3
First Submitted: August 7, 2008
First Posted: August 11, 2008
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:
Inflammation
Gingivitis
Pathologic Processes
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases