| CTRI Number |
CTRI/2021/11/037817 [Registered on: 03/11/2021] Trial Registered Prospectively |
| Last Modified On: |
06/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relationship of caries prevalence in special Children as Day Scholars and Boarders in Delhi Region |
|
Scientific Title of Study
|
Assessment of Dental Caries in Children with Special Health Care Needs amongst Day Scholars and Boarders in Delhi Region
- A Cross Sectional Study
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M Piraveen |
| Designation |
PG STUDENT |
| Affiliation |
Manav Rachna Dental College, Faculty of Dental Sciences,MRIIRS |
| Address |
Manav Rachna Dental College, Faculty of Dental Sciences, MRIIRS. Sector-43, Delhi-Surajkund Road,
Manav Rachna Dental College, Faculty of Dental Sciences, MRIIRS. Sector-43, Delhi-Surajkund Road,
Faridabad
HARYANA
121004
India |
| Phone |
8675484433 |
| Fax |
|
| Email |
piraveenganesh.pg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naresh Sharma |
| Designation |
Professor |
| Affiliation |
Manav Rachna Dental College, Faculty of Dental Sciences,MRIIRS |
| Address |
Manav Rachna Dental College, Faculty of Dental Sciences, MRIIRS. Sector-43, Delhi-Surajkund Road,
Manav Rachna Dental College, Faculty of Dental Sciences, MRIIRS. Sector-43, Delhi-Surajkund Road,
Faridabad
HARYANA
121004
India |
| Phone |
9871649627 |
| Fax |
|
| Email |
naresh.mrdc@mrei.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Piraveen |
| Designation |
PG STUDENT |
| Affiliation |
Manav Rachna Dental College, Faculty of Dental Sciences,MRIIRS |
| Address |
Manav Rachna Dental College, Faculty of Dental Sciences, MRIIRS. Sector-43, Delhi-Surajkund Road,
Manav Rachna Dental College, Faculty of Dental Sciences, MRIIRS. Sector-43, Delhi-Surajkund Road,
Faridabad
HARYANA
121004
India |
| Phone |
8675484433 |
| Fax |
|
| Email |
piraveenganesh.pg@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manav Rachna Dental College,Faculty of Dental Sciences,MRIIRS |
|
|
Primary Sponsor
|
| Name |
Dr M Piraveen |
| Address |
Manav Rachna Dental College,Faculty of Dental Sciences,MRIIRS,Manav Rachna Camous Road,Gadakhor Basti Village,Sector43,Faridabad |
| 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 |
| Dr M Piraveen |
Schools of Specially aided Children |
Nishtha special school, dilshad garden, Delhi.
Abhyaas Learning centre and special school, Derawal nagar, Delhi.
New Delhi
DELHI |
8675484433
piraveenganesh.pg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Manav Rachna Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Dental caries |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Children aged between 5 to 14 years.
The Children should be a Boarders or Day scholars.
The participants must be student in School for Special Children.
|
|
| ExclusionCriteria |
| Details |
Uncooperative during clinical oral examinations (definetly negative on Frankle behaviour rating scale).
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There is no difference between prevalence of dental caries among day scholars and boarders. |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Evaluate Prevalence Dental Caries in Boarders of a School for Special Children. |
baseline |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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)
|
20/02/2022 |
| 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="0"
Months="5"
Days="20" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To Evaluate and compare the Prevalence of Dental Caries in Children with Special Care Health Care Needs amongst Day Scholars and Boarders. To Evaluate Prevalence Dental Caries in Boarders of a School for Special Children. To Evaluate of Prevalence Dental Caries in Day Scholars of a School for Special Children. Demographic data including Age, Sex, Address, Name of the school will be noted. Written informed consent will be taken from the Institution/parents or guardian after explaining the design of the study. Clinical Oral examination will be done with mouth mirror and explorer. Data will be recorded as per WHO dmft proforma (2013). |