Effect of Antioxidant Intake on Resistin Levels In Patients With Gum Disease and Diabetes

Study Overview
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Brief Summary
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To evaluate the effectiveness of non surgical periodontal therapy in addition to antioxidant(ALA) on resistin levels in patients with type 2 diabetes and periodontal disease

Detailed Description
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A total of 40 patients with diabetes and chronic periodontitis attending the department of periodontics will be recruited in the study. 40 subjects will be randomly divided into two groups(control group and test group with 20 subjects in each group). Clinical parameters such as gingival index, periodontal index, random blood sugar levels(RBS) and glycosylated hemoglobin levels (Hb1aC) will be recorded at baseline and after 3 months and 2ml of blood sample will be collected by venepuncture ( baseline and after 3 months) and stored in Ethylenediaminetetraacetic acid containing vials to identify the levels of resistin in the patients by Enzyme linked immunosorbent assay. Group A will receive Alpha lipoic acid at baseline for a period of 3 months. Both the groups will receive scaling and rootplaning at baseline.

Official Title
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Effect of Systemic Administration of ALA (Alpha Lipoic Acid) as an Adjunct to Scaling and Rootplaning on Serum Resistin Levels in Patients With Chronic Periodontitis and Type 2 Diabetes Mellitus

Conditions
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Diabetes Mellitus, Periodontitis

Intervention / Treatment
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* Other: Alpha lipoic acid
* Procedure: Scaling and Root planing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diabetic patients with Chronic periodontitis. - Exclusion Criteria: Smokers, Pregnant & lactating women, Prior periodontal therapy within 3 months.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 60 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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ALA + Scaling and Root planing<br>Systemic antioxidant Alpha lipoic acid 1800mg/day in 3 divided doses for a period of 3 months(group B) | Other: Alpha lipoic acid<br>* Scaling and root planing will be done at baseline and systemic antioxidant Alpha lipoic acid 1800mg/day in 3 divided doses for a period of 3 months.<br>Procedure: Scaling and Root planing<br>* Scaling and root planing will be done at baseline.<br>|
| Placebo Comparator: Scaling and root planing only<br>Patients will receive scaling and root planning at baseline and 3 months(group A) | Procedure: Scaling and Root planing<br>* Scaling and root planing will be done at baseline.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Resistin Levels and HBAIC Levels | 2ml of blood sample will be collected by venepuncture at baseline and after 3 months and will be assessed by ELISA stored in EDTA containing vials to identify the levels of resistin in the patients by ELISA. Glycosylated hemoglobin levels (Hb1aC) will be recorded at baseline and after 3 months and assessed by Spectrophotometer. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gingival Index | Gingival index was recorded with william's periodontal probe at baseline and after 3 months | 3 months | 
| Probing pocket depth | Were recorded with william's periodontal probe at baseline and after 3 months | 3 months | 
| Clinical Attachment levels | Were recorded with william's periodontal probe at baseline and after 3 months | 3 Months |