| CTRI Number |
CTRI/2025/04/084979 [Registered on: 16/04/2025] Trial Registered Prospectively |
| Last Modified On: |
13/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening
Dentistry
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Evaluating oral health program in Irungattukottai |
|
Scientific Title of Study
|
Qualitative and Quantitative evaluation of a comprehensive oral health care program in Irungattukottai village, Kanchipuram district -A community trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jennifer Buela P |
| Designation |
MDS II- Post Graduate Resident |
| Affiliation |
Saveetha Dental College, Saveetha Institute of Medical and Technical Sciences [SIMATS], Saveetha University, |
| Address |
Room no .22, Public Health Dentistry Department, Saveetha Dental College, Saveetha Institute of Medical and Technical Sciences [SIMATS], Saveetha University, Chennai -77
Chennai
TAMIL NADU
600077
India |
| Phone |
8610647365 |
| Fax |
|
| Email |
152212003.sdc@saveetha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Srisakthi D |
| Designation |
Professor |
| Affiliation |
Saveetha Dental College, Saveetha Institute of Medical and Technical Sciences [SIMATS], Saveetha University |
| Address |
Room no .22, Public Health Dentistry Department, Saveetha Dental College, Saveetha Institute of Medical and Technical Sciences [SIMATS], Saveetha University, Chennai -77 .
Chennai
TAMIL NADU
600077
India |
| Phone |
8122399966 |
| Fax |
|
| Email |
srisakthi@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Jennifer Buela P |
| Designation |
MDS II- Post Graduate Resident |
| Affiliation |
Saveetha Dental College,Saveetha Institute of Medical and Technical Sciences [SIMATS], Saveetha University |
| Address |
Room no .22,Public Health Dentistry Department,Saveetha Dental College, Saveetha Institute of Medical and Technical Sciences [SIMATS], Saveetha University, Chennai -77
Chennai
TAMIL NADU
600077
India |
| Phone |
8610647365 |
| Fax |
|
| Email |
152212003.sdc@saveetha.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental College, Saveetha University |
|
|
Primary Sponsor
|
| Name |
Jennifer Buela P |
| Address |
Saveetha Dental College, Saveetha Institute of Medical and Technical Sciences [SIMATS], Saveetha University, Chennai -77 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| JENNIFER BUELA P |
Irungattukottai village, Kanchipuram district |
Irungattukottai village, Kanchipuram district-602117
Chennai
TAMIL NADU |
8610647365
152212003.sdc@saveetha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Saveetha Dental College - Institutional Human Ethical Committee (SDC-IHEC) |
Approved |
| Saveetha Dental College - Institutional Human Ethical Committee (SDC-IHEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Individuals with dental problems |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1. Preventive interventions 2.
Curative interventions 3.
Referral services 4.
Behavioural interventions 5.
Community based
interventions 6. Digital and technological interventions 7.
Policy and infrastructure interventions |
1. Oral health education, fluoride application and pit and fissure sealants. 2. Dental check up camps: periodic screening for dental caries, gingival diseases and other oral conditions, basic dental treatment: providing restorations, scaling, and extractions as needed. 3. cases requiring advanced treatment (eg: root canals, orthodontic care) are referred to nearby hospitals or dental colleges. 4. tobacco cessation programs and nutritional counselling. 5. training community health workers and social based oral health programs. 6. sending reminders for dental check ups, follow ups, and oral hygiene tips. 7. setting up rural dental clinic |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Permanent residents of Irungattukottai village.
|
|
| ExclusionCriteria |
| Details |
1.Terminally ill patients
2.Residents who are not willing
3.Residents who are not available even after 3 consecutive visits . |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Dental caries experience
2.Periodontal health
3.Oral health literacy
4.Oral mucosal lesions
5.Tobacco dependency
6.Dental Fluorosis
7. Unmet treatment needs. |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Oral Health Related Quality of Life for Children,Adults & Geriatrics
1.C-OIDP
2.OHIP 14
3.GOHAI |
2 years |
|
|
Target Sample Size
|
Total Sample Size="430"
Sample Size from India="430"
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)
|
25/04/2025 |
| 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="3"
Days="10" |
|
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
|
The study evaluates the effectiveness of a comprehensive oral health care program in Irungattukottai village, Kanchipuram district, through both qualitative and quantitative assessments. The community trial measures improvements in oral health status, awareness, and hygiene practices among residents before and after the program’s implementation. Quantitative data includes clinical examinations and statistical analysis of oral health indicators, while qualitative insights are gathered through surveys, interviews, and community feedback. The findings highlight the program’s impact on reducing oral diseases, increasing awareness, and improving oral hygiene behaviors, demonstrating the need for sustained community-based dental health initiatives. |