| CTRI Number |
CTRI/2025/09/094196 [Registered on: 03/09/2025] Trial Registered Prospectively |
| Last Modified On: |
02/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Improving Gum Health and Blood Sugar with Behaviour Change in People with Type 2 Diabetes Living in Urban Slums of New Delhi |
|
Scientific Title of Study
|
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 Acronym |
PERIDIAB |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Menka |
| Designation |
PhD Scholar |
| Affiliation |
MSMAIR, MAX-MIME and AcSIR |
| Address |
Max Society of Medical Academics Innovation and Research
26 Community Centre Behind PVR Anupam Goldy Traders Building
Saket New Delhi 110017
South
DELHI
110017
India |
| Phone |
8360629951 |
| Fax |
|
| Email |
Menka@maxhealthcare.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Budhiraja |
| Designation |
Group Medical Director and PhD Guide |
| Affiliation |
Max Healthcare |
| Address |
Max Super Specialty Hospital, 2 Press Enclave Road, Saket, New Delhi
South
DELHI
110017
India |
| Phone |
9810262954 |
| Fax |
|
| Email |
sbudhiraja@maxhealthcare.com |
|
Details of Contact Person
Public Query
|
| Name |
Menka |
| Designation |
PhD Scholar |
| Affiliation |
MSMAIR, MAX-MIME and AcSIR |
| Address |
Max Society of Medical Academics Innovation and Research
26 Community Centre Behind PVR Anupam Goldy Traders Building
Saket New Delhi 110017
South
DELHI
110017
India |
| Phone |
8360629951 |
| Fax |
|
| Email |
Menka@maxhealthcare.com |
|
|
Source of Monetary or Material Support
|
| MSMAIR (Max Society of Medical Academics Innovation and Research and Devki Devi Foundation), Imperial College London and National Institute of Health and Care Research NIHR |
|
|
Primary Sponsor
|
| Name |
MSMAIR- Max Society of Medical Academics Innovation and Research |
| Address |
MSMAIR, 26, Community Centre, Behind PVR Anupam, Goldy Traders Building,
Saket, New Delhi – 110017 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Imperial College London and National Institute of Health and Care Research NIHR |
Department of Epidemiology and Biostatistics
School of Public Health
Imperial College London
Faculty of Medicine
St Mary’s Campus
Norfolk Place, Paddington
London W2 1PG |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sandeep Budhiraja |
Devki Devi Foundation |
2, Press Enclave Road, Saket, New Delhi, 110017
South
DELHI |
9810262954
sbudhiraja@maxhealthcare.com |
| Menka |
Max Society of Medical Academics Innovation and Research |
26, Community Centre, Behind PVR Anupam, Goldy Traders Building,
Saket, New Delhi – 110017
South
DELHI |
08360629951
Menka@maxhealthcare.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMIITEE, DEVKI DEVI FOUNDATION |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Behaviour change intervention based on the Susan Michie Model-COM-B |
Participants will receive targeted interventions based on the Susan Michie Model, designed to improve periodontal health and include structured behaviour change modifications. The intervention model for periodontal health improvement will use the COM-B system, where capability, opportunity, and motivation interact to influence behaviour. Capability refers to psychological and physical capacity, including knowledge and skills. Motivation encompasses various brain processes that drive behaviour, including habitual, emotional, and analytical aspects. The opportunity comprises external factors enabling or prompting behaviour. This model emphasises that changing one component or more can influence behaviour. It allows for individual, group, or environmental perspectives and identifies necessary transformations based on the context. Further subdivisions within the components distinguish physical and psychological capability, physical and social opportunity, and reflective and automatic motivation. Targeting specific components facilitates achieving behavioural goals efficiently. Total duration of intervention is 12 months. |
| Comparator Agent |
Standard Oral Health and Lifestyle advice |
Control arm participants will receive Standard Oral Health and lifestyle advise to maintain diabetes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
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.
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.
|
Baseline, 6 months and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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.
Validation of the hypothesis regarding sustained improvements in oral health and glycemic control among study participants during the follow-up assessment post-behavioural change intervention, indicating the long-term impact and effectiveness of the intervention
|
6 months and 12 months |
|
|
Target Sample Size
|
Total Sample Size="286"
Sample Size from India="286"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |