| CTRI Number |
CTRI/2026/03/105589 [Registered on: 06/03/2026] Trial Registered Prospectively |
| Last Modified On: |
06/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Improving oral health habits in patients with type 2 diabetes through a Health Belief Model–based program |
|
Scientific Title of Study
|
Effectiveness of an Educational Intervention Based on the Health Belief Model in Promoting Oral Health Behaviors among Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Trial |
| Trial Acronym |
HBM-Diabetes Oral Health Trial (HBM-DENT) |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amaranath Behera |
| Designation |
2nd year mds |
| Affiliation |
S.C.B. Dental College and Hospital, Cuttack District, Odisha. |
| Address |
Department of Public Health Dentistry
S.C.B. Dental College and Hospital
Cuttack
ORISSA
753007
India |
| Phone |
08093157708 |
| Fax |
|
| Email |
dramaranathbehera@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Hemamalini Rath |
| Designation |
Professor and Head |
| Affiliation |
S.C.B. Dental College and Hospital, Cuttack District, Odisha. |
| Address |
Department of Public Health Dentistry
S.C.B. Dental College and Hospital
Cuttack
ORISSA
753007
India |
| Phone |
7008305751 |
| Fax |
|
| Email |
hema.hr@rediff.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Hemamalini Rath |
| Designation |
Professor and Head |
| Affiliation |
S.C.B. Dental College and Hospital, Cuttack District, Odisha. |
| Address |
Department of Public Health Dentistry
S.C.B. Dental College and Hospital
Cuttack
ORISSA
753007
India |
| Phone |
7008305751 |
| Fax |
|
| Email |
hema.hr@rediff.com |
|
|
Source of Monetary or Material Support
|
| S.C.B. Dental College and Hospital, Cuttack District, Odisha.PIN: 753007 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Hemamalini Rath |
S.C.B. Dental College and Hospital, Cuttack, Orisha |
Department of Public Health Dentistry
Cuttack
ORISSA |
7008305751
hema.hr@rediff.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE (IEC) SCB DENTAL COLLEGE & HOSPITAL, CUTTACK, ODISHA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Health Education |
An educational program designed using the Health Belief Model and delivered through PowerPoint presentations. The program includes structured sessions, demonstrations, and motivational counseling, focusing on improving oral hygiene behavior among patients with type 2 diabetes. A six month follow up period is planned to assess the effectiveness of the intervention |
| Comparator Agent |
Oral Hygiene Instruction |
Participants in the control group will receive standard oral hygiene instructions, including guidance on toothbrushing techniques, use of interdental aids.No structured educational sessions or motivational counseling will be provided. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Those diagnosed with type 2 diabetes mellitus at least for 1 year firmly established by a medical officer.
Those attending the OPD on customary follow-up for at least three visits .
Those completed upper primary education.
|
|
| ExclusionCriteria |
| Details |
Patients with type 1 diabetes, gestational diabetes, and patients who are unable or unwilling to participate in the study will all excluded.
A history of psychological disorders such as mood or anxiety disorders that will prevent them from receiving the intervention
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Significant difference in the change in mean Oral health Behavior Index score between both experimental and control group.Significant difference between the change in mean scores of each construct of HBM between both experimental and control group. |
6 MONTH |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Significant difference between the change in mean scores of each construct of HBM between both experimental and control group. |
6 MONTH |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
25/03/2026 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
After permission of respective authorities, The required no of diabetic patients of NCD clinic will be selected based on inclusion and exclusion criteria .participants will be randomised into two group experimental and control group.The structured tool data (in regional language) will be filled.Intervention in the experimental group will conducted , to motivate behavior change among the diabetic patient with based on the HBM theory, in a small group of 4–5 persons . First the training program will be designed as four 30 -minute sessions spread over the course of one month.In the performance section, patients will be instructed on the following behaviors: proper tooth brushing, flossingthe control group will receive only routine care which with preventive advice about maintenance of oral hygiene.
Both the groups will be followed up after 6 month to fill the same HBM structured tool (in local language) and Oral hygiene index will be recorded. |