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

Primary Purpose

Diabetes Mellitus, Periodontitis

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Alpha lipoic acid
Scaling and Root planing
Sponsored by
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes Mellitus

Eligibility Criteria

35 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diabetic patients with Chronic periodontitis.

-

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

Sites / Locations

  • Mohans Diabetic Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

ALA + Scaling and Root planing

Scaling and root planing only

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
May 5, 2016
Last Updated
March 10, 2017
Sponsor
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
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1. Study Identification

Unique Protocol Identification Number
NCT02775266
Brief Title
Effect of Antioxidant Intake on Resistin Levels In Patients With Gum Disease and Diabetes
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Periodontitis

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ALA + Scaling and Root planing
Arm Type
Active Comparator
Arm Description
Systemic antioxidant Alpha lipoic acid 1800mg/day in 3 divided doses for a period of 3 months(group B)
Arm Title
Scaling and root planing only
Arm Type
Placebo Comparator
Arm Description
Patients will receive scaling and root planning at baseline and 3 months(group A)
Intervention Type
Other
Intervention Name(s)
Alpha lipoic acid
Intervention Description
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
Procedure
Intervention Name(s)
Scaling and Root planing
Intervention Description
Scaling and root planing will be done at baseline.
Primary Outcome Measure Information:
Title
Serum Resistin Levels and HBAIC Levels
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Gingival Index
Description
Gingival index was recorded with william's periodontal probe at baseline and after 3 months
Time Frame
3 months
Title
Probing pocket depth
Description
Were recorded with william's periodontal probe at baseline and after 3 months
Time Frame
3 months
Title
Clinical Attachment levels
Description
Were recorded with william's periodontal probe at baseline and after 3 months
Time Frame
3 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diabetic patients with Chronic periodontitis. - Exclusion Criteria: Smokers, Pregnant & lactating women, Prior periodontal therapy within 3 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kinnera Surapaneni, [MDS]
Organizational Affiliation
PANINEEYA INSTITUTE OF DENTAL SCIENCES ROAD NO: 5, KAMALANAGAR DILSUKHNAGAR, HYDERABAD - 500060
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rekha R Koduganti, MDS Perio
Organizational Affiliation
Professor&HOD Dept.of.Periodontics,PMVIDS
Official's Role
Study Director
Facility Information:
Facility Name
Mohans Diabetic Centre
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
500029
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16881798
Citation
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.
Results Reference
background
PubMed Identifier
20142950
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.
Results Reference
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Effect of Antioxidant Intake on Resistin Levels In Patients With Gum Disease and Diabetes

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