| CTRI Number |
CTRI/2025/08/092176 [Registered on: 01/08/2025] Trial Registered Prospectively |
| Last Modified On: |
01/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
oral health status among tribal school children. |
|
Scientific Title of Study
|
Oral health status and access to dental care in tribal school children , aged 6-12 years in Salem district- a mixed method approach |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vishnupriya G |
| Designation |
Postgraduate student |
| Affiliation |
KSR Institue of Dental Science and Research. |
| Address |
KSR Institute of Dental Science and Research, KSR Kalvi Nagar, Thokkavadi, Tiruchengode.
Namakkal
TAMIL NADU
637215
India |
| Phone |
09498412476 |
| Fax |
|
| Email |
vishnu089921@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sharath Asokan |
| Designation |
Principal and Professor in the department of Dental Science and Research |
| Affiliation |
KSR Institute of Dental Science and Research, |
| Address |
KSR Institute of Dental Science and Research, KSR Kalvi Nagar, Thokkavadi, Tiruchengode.
Namakkal
TAMIL NADU
637215
India |
| Phone |
9843194402 |
| Fax |
|
| Email |
asokansharath@ksridsr.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Vishnupriya G |
| Designation |
Postgraduate student |
| Affiliation |
KSR Institue of Dental Science and Research. |
| Address |
KSR Institute of Dental Science and Research, KSR Kalvi Nagar, Thokkavadi, Tiruchengode.
Namakkal
TAMIL NADU
637215
India |
| Phone |
09498412476 |
| Fax |
|
| Email |
vishnu089921@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Vishnupriya G |
| Address |
KSR Institute of Dental Science and Research, KSR Kalvi Nagar, Thokkavadi, Tiruchengode - 637215. |
| Type of Sponsor |
Other [Dental college 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 Vishnupriya G |
KSR Institue of Dental Science and Research. |
KSR Institute of Dental Science and Research, KSR Kalvi Nagar, Thokkavadi, Tiruchengode - 637215
Namakkal
TAMIL NADU |
09498412476
vishnu089921@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KSRIDSR INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 6-12 years belonging to the tribal regions of Salem district.
|
|
| ExclusionCriteria |
| Details |
Children with special health care needs.
Children who do not provide consent.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To estimate the prevalence of oral health problems among tribal children aged 6-12 years.
To determine the treatment needs of the tribal children using the dental treatment needs index.
|
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To find association between BMI & dental caries status
To evaluate their access to dental care. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="650"
Sample Size from India="650"
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)
|
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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Oral health status and access to dental care in tribal school children aged 6-12 years in Salem district - A mixed method approach
The purpose of this mixed-method study is to evaluate the oral health status, treatment requirements, and obstacles to dental care of 6–12-year-old tribal children. Both the Institutional Ethics Committee (IEC) and the Institutional Review Board (IRB) have approved the study. There are two stages to the research. Tribal children will undergo oral screening in Phase I (quantitative) following informed parental consent. Standardized indices, such as the DMFT Index, PUFA Index, and ICDAS I scores, will be used to evaluate the state of oral health. To ascertain the frequency and seriousness of oral health problems in this population, the gathered data will subsequently be statistically analyzed.A more thorough investigation of the obstacles to dental care is part of Phase II (qualitative). Making use of a stratified random sampling technique, Phase I participants will be chosen for additional evaluation. Parents of these children will be interviewed in-person using a semi-structured questionnaire. A thematic framework will be used to analyze the collected qualitative data in order to find recurring themes and insights regarding the obstacles people face when trying to access dental care.
The study’s findings will primarily address two issues: the frequency of oral health issues in children from tribal communities and the underlying obstacles to receiving essential dental care in these areas.
|