Herbal Periodontal Patch (THPP) for Gingival Inflammation in Diabetics

Study Overview
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Brief Summary
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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.

Official Title
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The Effect Of A Transmucosal Herbal Periodontal Patch (THPP) on Gingival Inflammation in Diabetic Patients

Conditions
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Gingival Inflammation in Diabetic Patients

Intervention / Treatment
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* Drug: Transmucosal Herbal Periodontal Patch (THPP)
* Drug: Placebo Patch


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Transmucosal Herbal Periodontal Patch (THPP) | Drug: Transmucosal Herbal Periodontal Patch (THPP)<br>* Patch applied to oral gingiva<br>* Other names: Days 4-5: no patch;|
| Placebo Comparator: B<br>Placebo Patch | Drug: Placebo Patch<br>* Identical in shape and texture to treatment patch<br>* Other names: Days 4-5: no patch;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency and severity of any adverse event |  | 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. |  | 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gingivitis, diabetes mellitus, herbal, oral inflammation