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

Diabetes Mellitus Clinical Trial

— EARGD  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02775266
• Other study ID #: 00159
• Status: Completed
• Phase: N/A
• First received: May 5, 2016
• Last updated: March 10, 2017
• Start date: February 2016
• Est. completion date: October 2016

Study information

• Verified date: March 2017
• Source: Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 60 Years

Eligibility

Inclusion Criteria: Diabetic patients with Chronic periodontitis.

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Periodontitis

Intervention

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.

Locations

Country	Name	City	State
India	Mohans Diabetic Centre	Hyderabad	Telangana

Sponsors (1)

Lead Sponsor	Collaborator
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

Country where clinical trial is conducted

India, 

References & Publications (2)

Mealey BL, Oates TW; American Academy of Periodontology.. Diabetes mellitus and periodontal diseases. J Periodontol. 2006 Aug;77(8):1289-303. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Gingival Index	Gingival index was recorded with william's periodontal probe at baseline and after 3 months	3 months
Secondary	Probing pocket depth	Were recorded with william's periodontal probe at baseline and after 3 months	3 months
Secondary	Clinical Attachment levels	Were recorded with william's periodontal probe at baseline and after 3 months	3 Months