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Completed

NCT Number: NCT02775266

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

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

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Mouth Diseases Nutritional and Metabolic Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

35 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mohans Diabetic Centre

Hyderabad, Telangana, 500029, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Diabetic patients with Chronic periodontitis.

-

Exclusion criteria

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

Treatment and study plan

Alpha lipoic acid

Other

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.

Scaling and Root Planing

Procedure

Scaling and root planing will be done at baseline.

Primary outcomes

  1. 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 outcomes

  1. Gingival Index

    Time frame: 3 months

    Gingival index was recorded with william's periodontal probe at baseline and after 3 months

  2. Probing pocket depth

    Time frame: 3 months

    Were recorded with william's periodontal probe at baseline and after 3 months

  3. Clinical Attachment levels

    Time frame: 3 Months

    Were recorded with william's periodontal probe at baseline and after 3 months

Sponsors and collaborators

Lead sponsor

Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

Other

Registry information

Official study title

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

Acronym: EARGD

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 17, 2016
Registry last updated
Mar 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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