Herbal Periodontal Patch (THPP) for Gingival Inflammation in Diabetics

This study has suspended participant recruitment.
(Failure to recruit)
Sponsor:
Information provided by:
Izun Pharma Ltd
ClinicalTrials.gov Identifier:
NCT00731432
First received: August 7, 2008
Last updated: July 19, 2011
Last verified: August 2008
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • frequency and severity of any adverse event [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. Y. Caine, Herzog Hospital, Jerusalem, Israel
ClinicalTrials.gov Identifier: NCT00731432     History of Changes
Other Study ID Numbers: C-3
Study First Received: August 7, 2008
Last Updated: July 19, 2011
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

ClinicalTrials.gov processed this record on September 18, 2014