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

NCT ID: NCT02775266

Last Updated: 2017-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-10-31

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.

Conditions

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Diabetes Mellitus Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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ALA + Scaling and Root planing

Systemic antioxidant Alpha lipoic acid 1800mg/day in 3 divided doses for a period of 3 months(group B)

Group Type ACTIVE_COMPARATOR

Alpha lipoic acid

Intervention Type 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

Intervention Type PROCEDURE

Scaling and root planing will be done at baseline.

Scaling and root planing only

Patients will receive scaling and root planning at baseline and 3 months(group A)

Group Type PLACEBO_COMPARATOR

Scaling and Root planing

Intervention Type PROCEDURE

Scaling and root planing will be done at baseline.

Interventions

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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.

Intervention Type OTHER

Scaling and Root planing

Scaling and root planing will be done at baseline.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

\-
Minimum Eligible Age

35 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

OTHER

Sponsor Role lead

Responsible Party

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kinnera surapaneni

PG student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kinnera Surapaneni, [MDS]

Role: PRINCIPAL_INVESTIGATOR

PANINEEYA INSTITUTE OF DENTAL SCIENCES ROAD NO: 5, KAMALANAGAR DILSUKHNAGAR, HYDERABAD - 500060

Rekha R Koduganti, MDS Perio

Role: STUDY_DIRECTOR

Professor&HOD Dept.of.Periodontics,PMVIDS

Locations

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Mohans Diabetic Centre

Hyderabad, Telangana, India

Site Status

Countries

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India

References

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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.

Reference Type BACKGROUND
PMID: 16881798 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20142950 (View on PubMed)

Other Identifiers

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00159

Identifier Type: -

Identifier Source: org_study_id

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