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

Not Applicable

Completed

• Conditions: Diabetes Mellitus; Periodontitis
• Interventions: Procedure: Scaling and Root planing; Other: Alpha lipoic acid

• Registration Number: NCT02775266
• Lead Sponsor: Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-05-05
• Study First Submitted QC: 2016-05-12
• Study First Posted: 2016-05-17
• Primary Completion: 2016-09
• Study Completion: 2016-10
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-10
• Last Update Posted: 2017-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Diabetic patients with Chronic periodontitis.

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Exclusion Criteria

Smokers, Pregnant & lactating women, Prior periodontal therapy within 3 months.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Scaling and root planing only	Scaling and Root planing	Patients will receive scaling and root planning at baseline and 3 months(group A)
ALA + Scaling and Root planing	Alpha lipoic acid	Systemic antioxidant Alpha lipoic acid 1800mg/day in 3 divided doses for a period of 3 months(group B)
ALA + Scaling and Root planing	Scaling and Root planing	Systemic antioxidant Alpha lipoic acid 1800mg/day in 3 divided doses for a period of 3 months(group B)

Primary Outcome Measures

Name	Time	Method
Serum Resistin Levels and HBAIC Levels	3 months	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.

Secondary Outcome Measures

Name	Time	Method
Clinical Attachment levels	3 Months	Were recorded with william's periodontal probe at baseline and after 3 months
Probing pocket depth	3 months	Were recorded with william's periodontal probe at baseline and after 3 months
Gingival Index	3 months	Gingival index was recorded with william's periodontal probe at baseline and after 3 months

Trial Locations

Locations (1)

Mohans Diabetic Centre; 🇮🇳 Hyderabad, Telangana, India