| CTRI Number |
CTRI/2024/07/070404 [Registered on: 10/07/2024] Trial Registered Prospectively |
| Last Modified On: |
27/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Occurrence of tooth defects and its relation with oral health related quality of life a study for children aged 6 to 13 years |
|
Scientific Title of Study
|
Prevalence of developmental defects of enamel and its association with oral health related quality of life in six to thirteen year old children 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 Pooja Gade |
| Designation |
Post Graduate Student (MDS) |
| Affiliation |
YMT Dental College And Hospital Kharghar Navi Mumbai |
| Address |
Department of Pediatric And Preventive Dentistry.
G .D Pol Foundation, YMT Dental College And Hospital Kharghar Navi Mumbai. 410210
G .D Pol Foundation YMT Dental College And Hospital Kharghar Navi Mumbai 410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
7219289545 |
| Fax |
|
| Email |
poojagade7198@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Indu Varkey |
| Designation |
Reader |
| Affiliation |
YMT Dental College And Hospital Kharghar Navi Mumbai |
| Address |
Department of Pediatric and Preventive Dentistry. G .D Pol Foundation YMT Dental College And Hospital Kharghar Navi Mumbai 410210
G .D Pol Foundation YMT Dental College And Hospital Kharghar Navi Mumbai 410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9619486124 |
| Fax |
|
| Email |
induvarkey08@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja Gade |
| Designation |
Post Graduate Student (MDS) |
| Affiliation |
YMT Dental College And Hospital Kharghar Navi Mumbai |
| Address |
Department of Pediatric and Preventive Dentistry, G .D Pol Foundation, YMT Dental College And Hospital Kharghar Navi Mumbai 410210
G .D Pol Foundation YMT Dental College And Hospital Kharghar Navi Mumbai 410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
7219289545 |
| Fax |
|
| Email |
poojagade7198@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatric and Preventive dentistry,
YMT Dental college and Hospital, Kharghar, Navi Mumbai, Raigarh, State- Maharashtra,
India, 410210
|
|
|
Primary Sponsor
|
| Name |
Dr Pooja Gade |
| Address |
At Malharwadi Post Baragaon Nandur Tal Rahuri Dist Ahmednagar 413705 |
| Type of Sponsor |
Other [Self Funded] |
|
|
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 Pooja Gade |
Y.M.T Dental College and Hospital |
Department of Pediatric
and Preventive Dentistry
Institutional Area, Sector
4,Kharghar, 410210
Raigarh
MAHARASHTRA
Raigarh
MAHARASHTRA
Raigarh
MAHARASHTRA |
7219289545
poojagade7198@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, YMT Dental College and Hospital, Navi Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
13.00 Year(s) |
| Gender |
Both |
| Details |
Healthy children in the age range of six to thirteen years. |
|
| ExclusionCriteria |
| Details |
a) Children with special health care needs who may hamper data collection.
b) Teeth with extracoronal restorations.
c) Patient undergoing or have previously undergone orthodontic treatment.
d) Parents who refuse to give consent.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To assess the prevalence of Developmental Defects of Enamel in permanent teeth in six to thirteen year old children.
2. To assess Oral health related quality of life ( OHRQoL) using child oral health impact profile (COHIP) scale in six to thirteen year old children.
3. To assess the association of Developmental Defects of Enamel in permanent teeth with Oral health related quality of life (OHRQoL) in six to thirteen year old children.
|
At baseline only, no further recall |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the association of Developmental Defects of Enamel in permanent teeth with Gestation period in six to thirteen year old children. |
At baseline only, no further recall |
|
|
Target Sample Size
|
Total Sample Size="225"
Sample Size from India="225"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="225" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2024 |
| Date of Study Completion (India) |
30/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/01/2026 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In our study we plan to assess and compare1. To assess the prevalence of Developmental Defects of Enamel in permanent teeth in six to thirteen year old children. 2. To assess Oral health related quality of life ( OHRQoL) using child oral health impact profile (COHIP) scale in six to thirteen year old children.
3. To assess the association of Developmental Defects of Enamel in permanent teeth with Oral health related quality of life (OHRQoL) in six to thirteen year old children. |