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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: Single (Participant)
  • Study Primary Completion Date: September 2016

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.

Interventions

  • Other: Alpha lipoic acid
    • 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.
  • Procedure: Scaling and Root planing
    • Scaling and root planing will be done at baseline.

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Serum Resistin Levels and HBAIC Levels
    • Time Frame: 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 Measures

  • Gingival Index
    • Time Frame: 3 months
    • Gingival index was recorded with william’s periodontal probe at baseline and after 3 months
  • Probing pocket depth
    • Time Frame: 3 months
    • Were recorded with william’s periodontal probe at baseline and after 3 months
  • Clinical Attachment levels
    • Time Frame: 3 Months
    • Were recorded with william’s periodontal probe at baseline and after 3 months

Participating in This Clinical Trial

Inclusion Criteria

Diabetic patients with Chronic periodontitis. - Exclusion Criteria:

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

Gender Eligibility: All

Minimum Age: 35 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
  • Provider of Information About this Clinical Study
    • Principal Investigator: kinnera surapaneni, PG student – Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
  • Overall Official(s)
    • Kinnera Surapaneni, [MDS], Principal Investigator, PANINEEYA INSTITUTE OF DENTAL SCIENCES ROAD NO: 5, KAMALANAGAR DILSUKHNAGAR, HYDERABAD – 500060
    • Rekha R Koduganti, MDS Perio, Study Director, Professor&HOD Dept.of.Periodontics,PMVIDS

References

Mealey BL, Oates TW; American Academy of Periodontology. Diabetes mellitus and periodontal diseases. J Periodontol. 2006 Aug;77(8):1289-303. doi: 10.1902/jop.2006.050459.

Pendyala G, Thomas B, Kumari S. The challenge of antioxidants to free radicals in periodontitis. J Indian Soc Periodontol. 2008 Sep;12(3):79-83. doi: 10.4103/0972-124X.44100.

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