Effect of Antioxidant Intake on Resistin Levels In Patients With Gum Disease and Diabetes
EARGD
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
1 other identifier
interventional
40
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes-mellitus
Started Feb 2016
Shorter than P25 for not_applicable diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 5, 2016
CompletedFirst Posted
Study publicly available on registry
May 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedMarch 13, 2017
March 1, 2017
7 months
May 5, 2016
March 10, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Gingival Index
3 months
Probing pocket depth
3 months
Clinical Attachment levels
3 Months
Study Arms (2)
ALA + Scaling and Root planing
ACTIVE COMPARATORSystemic antioxidant Alpha lipoic acid 1800mg/day in 3 divided doses for a period of 3 months(group B)
Scaling and root planing only
PLACEBO COMPARATORPatients will receive scaling and root planning at baseline and 3 months(group A)
Interventions
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 will be done at baseline.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mohans Diabetic Centre
Hyderabad, Telangana, 500029, India
Related Publications (2)
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.
PMID: 16881798BACKGROUNDPendyala 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.
PMID: 20142950BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kinnera Surapaneni, [MDS]
PANINEEYA INSTITUTE OF DENTAL SCIENCES ROAD NO: 5, KAMALANAGAR DILSUKHNAGAR, HYDERABAD - 500060
- STUDY DIRECTOR
Rekha R Koduganti, MDS Perio
Professor&HOD Dept.of.Periodontics,PMVIDS
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PG student
Study Record Dates
First Submitted
May 5, 2016
First Posted
May 17, 2016
Study Start
February 1, 2016
Primary Completion
September 1, 2016
Study Completion
October 1, 2016
Last Updated
March 13, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share