Back to resultsHerbal Periodontal Patch (THPP) for Gingival Inflammation in Diabetics
Primary Purpose
Gingival Inflammation in Diabetic Patients
Status
Suspended
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Transmucosal Herbal Periodontal Patch (THPP)
Placebo Patch
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Inflammation in Diabetic Patients focused on measuring gingivitis, diabetes mellitus, herbal, oral inflammation
Eligibility 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
Sites / Locations
- Herzog Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
A
B
Arm Description
Transmucosal Herbal Periodontal Patch (THPP)
Placebo Patch
Outcomes
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
Secondary Outcome Measures
frequency and severity of any adverse event
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00731432
Brief Title
Herbal Periodontal Patch (THPP) for Gingival Inflammation in Diabetics
Official Title
The Effect Of A Transmucosal Herbal Periodontal Patch (THPP) on Gingival Inflammation in Diabetic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Suspended
Why Stopped
Failure to recruit
Study Start Date
August 2008 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Izun Pharma Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Inflammation in Diabetic Patients
Keywords
gingivitis, diabetes mellitus, herbal, oral inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Transmucosal Herbal Periodontal Patch (THPP)
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Placebo Patch
Intervention Type
Drug
Intervention Name(s)
Transmucosal Herbal Periodontal Patch (THPP)
Other Intervention Name(s)
Day 1: 1 patch X 3/d, Day 2-3: 1 patch X1/d, Days 4-5: no patch
Intervention Description
Patch applied to oral gingiva
Intervention Type
Drug
Intervention Name(s)
Placebo Patch
Other Intervention Name(s)
Day 1: 1 patch X 3/d, Day 2-3: 1 patch X1/d, Days 4-5: no patch
Intervention Description
Identical in shape and texture to treatment patch
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
frequency and severity of any adverse event
Time Frame
5 days
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oded Yaniv, DMD
Organizational Affiliation
Izun Pharma Limited
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herzog Hospital
City
Jerusalem
ZIP/Postal Code
91035
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Herbal Periodontal Patch (THPP) for Gingival Inflammation in Diabetics
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