| CTRI Number |
CTRI/2024/01/061350 [Registered on: 11/01/2024] Trial Registered Prospectively |
| Last Modified On: |
02/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess the oral health status of working mothers who are teachers in Udupi Taluk, Karnataka |
|
Scientific Title of Study
|
Assessment of the Oral Health Status and Treatment Needs of Government Higher Primary School Teachers cum Mothers in Udupi Taluk, Karnataka: a cross-sectional 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. Ramprasad VP |
| Designation |
Head of Department, Public Health Dentistry |
| Affiliation |
Manipal College of Dental Sciences, Manipal, Manipal Academy of Higher Education |
| Address |
Room No. 8
Department of Public Heath Dentistry
Manipal College of Dental Sciences
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
vasthare.ram@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramprasad VP |
| Designation |
Head of Department, Public Health Dentistry, Manipal College of Dental Sciences, Manipal |
| Affiliation |
Manipal College of Dental Sciences, Manipal, Manipal Academy of Higher Education |
| Address |
Room No. 8
Department of Public Heath Dentistry
Manipal College of Dental Sciences
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845100424 |
| Fax |
|
| Email |
vasthareram@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramprasad VP |
| Designation |
Head of Department, Public Health Dentistry, Manipal College of Dental Sciences, Manipal |
| Affiliation |
Manipal College of Dental Sciences, Manipal, Manipal Academy of Higher Education |
| Address |
Room No. 8
Department of Public Heath Dentistry
Manipal College of Dental Sciences
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845100424 |
| Fax |
|
| Email |
vasthareram@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal College of Dental Sciences,
Manipal,
Manipal Academy of Higher Education |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
V. Ramalingaswami Bhawan, P.O. Box No. 4911
Ansari Nagar, New Delhi - 110029, India |
| Type of Sponsor |
Government funding agency |
|
|
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 Anushka Das |
Kasturba medical college and hospitals, Dental Department |
Madhav Nagar
Manipal
Karnataka
576104
Udupi
KARNATAKA |
8800961490
anushkadasofficial25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Oral health status |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
24.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Participant should be working as a government higher primary school teacher
Participant should be within the age group of 24 to 60 years
Participant should be a mother of 1 or 2 or 3 children
Participant should be a resident of Udupi Taluk of Udupi District, Karnataka state
Participant should be willing to give consent
Mothers with adopted children |
|
| ExclusionCriteria |
| Details |
Participants not willing to give consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Oral health status, treatment needs |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Awareness about oral health status |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="352"
Sample Size from India="352"
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)
|
16/01/2024 |
| 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) |
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
|
It is a cross-sectional study to assess the oral health status and treatment needs of Government Higher Primary School teachers cum mothers in Udupi Taluk, Karnataka. Data will be collected using structured questionnaire and oral health indices and inferences will be drawn accordingly. This study will help establish oral health awareness and determine the oral health status among working mothers. |