| CTRI Number |
CTRI/2024/07/069814 [Registered on: 02/07/2024] Trial Registered Prospectively |
| Last Modified On: |
27/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relation of tooth decay with oral health related quality of life in six to thirteen year old children a cross sectional study |
|
Scientific Title of Study
|
Association of dental caries status 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 Krinal Pistolwala |
| Designation |
PG student |
| Affiliation |
Y.M.T Dental college and hospital Kharghar , Navi Mumbai |
| Address |
Room no 21 department of Pediatric and Preventive dentistry, Y.M.T Dental college and Hospital, sector 4
Kharghar
Raigarh
MAHARASHTRA
410210
India |
| Phone |
7021244517 |
| Fax |
|
| Email |
krinaz.ndk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amar Katre |
| Designation |
Professor |
| Affiliation |
Y.M.T Dental college and hospital Kharghar , Navi Mumbai |
| Address |
Room no. 21, Department of Pediatric
and Preventive Dentistry, YMT Dental College and Hospital, sector 4,Kharghar
Raigarh
MAHARASHTRA
410210
India |
| Phone |
|
| Fax |
|
| Email |
amar_katre@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krinal Pistolwala |
| Designation |
PG student |
| Affiliation |
Y.M.T Dental college and hospital Kharghar , Navi Mumbai |
| Address |
Room no.21 department of pediatric and preventive dentistry, Y.M.T Dental college and hospital, Sector 4, Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
7021244517 |
| Fax |
|
| Email |
krinaz.ndk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Krinal Pistolwala
702,Namra Heights, Plot no. 89, Sector 19, Kharghar, Navi Mumbai, Maharashtra , India- 410210 |
|
|
Primary Sponsor
|
| Name |
Dr Krinal Pistolwala |
| Address |
702, Namra Heights, Plot no - 89, Sec-19, Kharghar, Navi Mumbai, Maharashtra, India-410210 |
| 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 Krinal Pistolwala |
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 |
7021244517
krinaz.ndk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, YMT Dental College And Hospital, Kharghar 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 between six to thirteen years of age with mixed dentition and their parents. |
|
| ExclusionCriteria |
| Details |
1.Children who are physically or mentally challenged and/or medically compromised and those having developmental anomalies.
2.Children whose general condition interferes with examination and data collection.
3.Children whose parents refuse to give consent.
4. Children who have completed orthodontic treatment.
5. Children who have acute infection in oro dental region on the day of examination. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To assess dental caries prevalence using DMFT index in six- to thirteen-year-old children
2. To assess the OHRQoL using COHIP in six- to thirteen-year-old children.
3. To assess the association between caries status with OHRQoL in six- to thirteen-year-old children. |
At baseline only, no further recall |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the chewing performance using Karaduman Chewing Performance Scale in six- to thirteen-year-old children.
2. To assess the association between dental caries status and chewing performance in six- to thirteen-year-old children.
|
At baseline only, no further recall |
|
|
Target Sample Size
|
Total Sample Size="295"
Sample Size from India="295"
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)
|
01/08/2024 |
| 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 Yet Recruiting |
| 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
|
Dental caries is a multi- factorial disease that primarily results due to
the alteration in physiological equilibrium between tooth minerals and
oral microbial biofilms. Oral Health Related Quality of Life (OHRQoL) is an integral part of
general health and wellbeing and has been recognized by WHO as an
important segment of Global Oral Health Programme. Dental caries has been associated with a negative impact on OHRQol
however, research in this field, especially the Indian subcontinent is
scanty, hence the need of this investigation. In our study we plan to assess dental caries prevalence using DMFT index in six- to thirteen-year-old children. To assess the OHRQoL using COHIP in six- to thirteen-year-old children. To assess the association between dental caries status with OHRQoL in six- to thirteen-year-old children. |