Herbal Periodontal Patch (THPP) for Gingival Inflammation in Diabetics
Herbal Periodontal Patch (THPP) for Gingival Inflammation in Diabetics
ClinicalTrials.gov
This study is currently recruiting participants.
Verified by Izun Pharma Ltd, August 2008
Sponsored by: Izun Pharma Ltd
Information provided by: Izun Pharma Ltd
ClinicalTrials.gov Identifier: NCT00731432
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: Gingival Inflammation in Diabetic Patients
Intervention: Drug: Transmucosal Herbal Periodontal Patch (THPP)
Drug: Placebo Patch
Phase: Phase II
Study Type: Interventional
Study Design: Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Placebo Control, Randomized, Safety/Efficacy Study, 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
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
A: Experimental - Transmucosal Herbal Periodontal Patch (THPP)
Drug: Transmucosal Herbal Periodontal Patch (THPP)
Patch applied to oral gingiva
B: Placebo Comparator - Placebo Patch
Drug: Placebo Patch
Identical in shape and texture to treatment 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00731432
Contacts
Contact: Aron Saffer, DDS
972-2-5860780 ext 101
Locations: Israel
Herzog Hospital
Jerusalem, Israel, 91035
Sponsors and Collaborators:
Izun Pharma Ltd
Investigators:
Principal Investigator: Oded Yaniv, DMD (Izun Pharma Limited)
Responsible Party: Herzog Hospital, Jerusalem, Israel ( Dr. Y. Caine )
Study ID Numbers: C-3
Study First Received: August 7, 2008
Last Updated: August 8, 2008
ClinicalTrials.gov Identifier: NCT00731432
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration
ClinicalTrials.gov processed this record on March 06, 2009
