Determining the Epidemiologic Association between Periodontal Disease with Type 2 Diabetes and the Impact of Behavioural Change Intervention in Improving Periodontal Health and Glycemic Control in the urban slum population of New Delhi.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 286
- Locations
- 2
- Primary Endpoint
- Verification of the hypothesis regarding the comparable prevalence and severity of periodontal disease and Type 2 Diabetes mellitus within the urban slum population of New Delhi.
Study Overview
Brief Summary
This study aims to determine the epidemiologic association between periodontal disease and type 2 diabetes mellitus and to evaluate the impact of a behavioural change intervention on improving periodontal health and glycemic control among adults in urban slums of New Delhi. A randomized controlled trial will be conducted among diabetic individuals using the COM-B-based Susan Michie model for intervention. Participants will be assessed at baseline, 6, and 12 months for oral health (CPI, LOA), glycaemic markers (FBG, HbA1c), and lifestyle behaviours. The study addresses a critical public health gap and aims to inform integrated strategies for managing diabetes and oral health in underserved populations.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Diabetic participants from the GHRU Cohort (CTRI/2022/02/040650) with Community Periodontal Index (CPI) scores between 1 and 4 and Loss of Attachment (LOA) scores between 0 and 4 on oral examination will be included in the study.
Exclusion Criteria
- •Participants without diabetes will be excluded from the study.
- •Participants with a CPI score of 0 (Healthy), CPI Score of X (edentulous) and LOA score of X (edentulous) will be excluded from the study.
- •Pregnant and lactating females will be excluded Patients with terminal illness will be excluded.
Outcomes
Primary Outcomes
Verification of the hypothesis regarding the comparable prevalence and severity of periodontal disease and Type 2 Diabetes mellitus within the urban slum population of New Delhi.
Time Frame: Baseline, 6 months and 12 months
Confirmation of the anticipated significant improvement in oral health outcomes and glycemic control among participants following the behavioural change intervention, highlighting the effectiveness of the intervention in addressing health disparities in this vulnerable population.
Time Frame: Baseline, 6 months and 12 months
Secondary Outcomes
- Identification of specific risk factors, including dietary habits, socio-economic status, tobacco and alcohol use, and oral hygiene practices, contributing significantly to the association between periodontal disease and Type 2 Diabetes in the urban slum context, informing targeted interventions and preventive strategies.
Investigators
Menka
MSMAIR, MAX-MIME and AcSIR