| CTRI Number |
CTRI/2025/08/092840 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
15/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of training Community Health Officers and ASHA Workers in increasing detection and referral of oral precancerous and cancerous cases from rural areas of Rohtak District,Haryana.
|
|
Scientific Title of Study
|
Effectiveness of training and utilization of primary health professionals in early detection of oral cancer and potentially malignant disorder among rural population of Rohtak district: A quasi experimental study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Kalpana Sangwan |
| Designation |
PG Student |
| Affiliation |
PGIDS,Rohtak |
| Address |
Department of Public Health Dentistry,PGIDS,Rohtak,Haryana
A-57,Suncity sec-36
Rohtak,Haryana
Rohtak
HARYANA
124001
India |
| Phone |
9115868789 |
| Fax |
|
| Email |
drkalapnasangwan12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Manjunath B.C. |
| Designation |
Sr. Prfessor and head |
| Affiliation |
PGIDS,ROHTAK |
| Address |
Department Of Public Health
Dentistry, PGIDS,Rohtak Haryana
Rohtak
HARYANA
124001
India |
| Phone |
9968083725 |
| Fax |
|
| Email |
bcmanju10@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
KALPANA |
| Designation |
PG STUDENT FINAL YEAR |
| Affiliation |
PGIDS,ROHTAK |
| Address |
DEPARTMENT OF PUBLIC HEALTH DENTISTRY PGIDS,RPHTAK HARYANA
INDIA
A-57,SUNCITY SECTOR 36
ROHTAK,HARYANA
Rohtak
HARYANA
124001
India |
| Phone |
9115868789 |
| Fax |
|
| Email |
drkalapnasangwan12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Kalpana Sangwan
A-57,Suncity sec-36
Rohtak,Haryana
Pin code-124001 |
|
|
Primary Sponsor
|
| Name |
Department of Public Health Dentistry |
| Address |
Room no 14,PGIDS,Rohtak,Haryana
India,Pincode-124001 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Kalpana |
Rural areas of Rohtak District,Haryana |
Department of Public Health Dentistry,PGIDS,Rohtak,Haryana
Rohtak
HARYANA |
09115868789
1262-283876
drkalapnasangwan12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BIOMEDICAL RESEARCH ETHICS COMMITTEE PGIMS ROHTAK |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, (2) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NO ORAL HEALTH TRAINING |
NO ORAL HEALTH TRAINING |
| Intervention |
ORAL HEALTH TRAINING |
participants will be educated through brochures having colored clinical photographs of oral lesions, power point presentations, step wise clinical live demonstrations of oral self-examination and details of toluidine blue staining hands- on procedure. One session will last for 40-45 minutes approximately. The participants will be given the opportunity to ask and clarify the doubts. The screening procedure will be demonstrated by five participants selected randomly to ensure comprehension and understandability.It will also include Brochure, Power Point Presentations and lectures providing adequate information to generate awareness about the concept behind formulation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Community Health Officers (CHOs) who are willing to participate and who give their consent for training and participation in the study
2. Accredited Social Health Activists (ASHAs) who are willing to participate and who give their consent for training and participation in the study. |
|
| ExclusionCriteria |
| Details |
Community Health Officers (CHOs) who are not willing to participate and who give their consent for training and participation in the study
2. Accredited Social Health Activists (ASHAs) who are not willing to participate and who give their consent for training and participation in the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in detection rate of oral potentially malignant disorders and malignancy. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Knowledge, attitude & practices of Community Health Officers & ASHA Workers. |
At baseline & after 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="114"
Sample Size from India="114"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/08/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
It will be a Quasi experimental design of study in which Community Health Officers (CHO’s), Accredited Social Health Activists (ASHA’s) will be recruited from PHCs of Rohtak district.The study will be conducted in three phases.A pre-designed structured questionnaire was administered to collect data regarding socio-demographic data, knowledge, attitude, and practices before and after oral health training from the health professionals. The ASHA workers will distribute brochures among smokers in their areas and will invite them for oral screening camps conducted by the CHOs.Suspected cases will be referred by CHOS after toluidine blue staining to Dentist at PHCs who further refer them to PGIDS for comprehensive evaluation.This can reduce overall mortality and morbidity due to oral cancer. |