Stevia Rebaudiana Bertoni on Levels of GCF Glucose and Bio-markers in Diabetics.

Study Overview
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Brief Summary
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With the increase in the incidence of diabetes and obesity, among other artificial sweeteners the need of natural non-caloric sweetener with acceptable taste and without any adverse effects is demanding.So,the use of stevia presents beneficial effects to general and oral health and its properties could result potentially effective in the treatment of periodontal diseases.

Detailed Description
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Stevia is considered as a novel molecule, because it is 100% natural and non caloric sweetener, with more sweetness than sucrose, without any adverse effects. It also demonstrates multiple benefits like anti-plaque effect, anti-diabetic effect, anti-periodontophatics properties, anti-hypertensive properties, anti-cariogenic properties etc. There are many studies conducted on stevia in humans, which justifies my study.

Official Title
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Efficacy of Stevia Rebaudiana Bertoni on Levels of GCF Glucose and Bio-markers in Diabetic Patients With Periodontitis-A Split Mouth Randomized Controlled Trial.

Conditions
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Periodontitis

Intervention / Treatment
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* Drug: stevia rebaudiana bertoni
* Other: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects that will be included in the study are in the age group ranging from 20-70 years -with established diabetes and under medication to maintain normal glycemic state i.e;Hb1Ac < 7％. Oral findings including the presence of minimum of 16 natural teeth with minimum of 4 nonadjacent sites showing pocket depths≥ 5 mm. Exclusion Criteria: Subjects will be excluded from the study if they are using any type of mouth-rinses or if they had underwent any periodontal therapy within the 3-months of the study or if they were under antibiotics within the 3-months of the study.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: one group of subjects receives intervention where as other group of subjects receive placebo.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: stevia rebaudiana bertoni<br>Randomly in all subjects one quadrant will be allotted as test site for placing stevia gel in the gingival sulcus having probing depth ≥ 5mm after performing thorough scaling and root planing. | Drug: stevia rebaudiana bertoni<br>* Stevia has an anti-plaque effect because of its ability in decreasing the formation of bacterial insoluble polymers.It significantly decreases the production of TNF-R and IL-1a and slightly decreases the production of NO in stimulated cells with LPS and THP-1 showing its anti-inflammatory properties.These characteristics in combination with anti-diabetic properties could results in the effective treatment of periodontal diseases.<br>* Other names: sweet tulasi;|
| Placebo Comparator: placebo<br>Other quadrant will be allotted as a control site for placing placebo in the gingival sulcus having PD≥ 5mm after performing thorough scaling and root planing. | Other: placebo<br>* A placebo without the active drug will be placed in the control sites.<br>* Other names: Control group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bio-marker (Ghrelin) levels in Gingival crevicular fluid. | GCF samples can be eluted from the strips by placing them in Eppendrof® tubes that contained 500 micro-litre of buffer and will be stored at -80℃ until analysis was done. The levels of GCF Ghrelin will be evaluated by using commercially available ELISA kit. | From baseline to 6-months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing depth | Probing depth (PD): Distance from the gingival margin to the bottom of gingival sulcus in mm. | From baseline to 6-months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biomarkers, Gingival crevicular fluid, Glucose, Diabetes