| CTRI Number |
CTRI/2021/06/033940 [Registered on: 01/06/2021] Trial Registered Prospectively |
| Last Modified On: |
01/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
ASSOCIATION OF DENTAL ANXIETY AND ORAL HEALTH RELATED
QUALITY OF LIFE, IN SIX TO TWELVE YEAR OLD CHILDREN. |
|
Scientific Title of Study
|
ASSOCIATION OF DENTAL ANXIETY AND ORAL HEALTH RELATED
QUALITY OF LIFE, IN SIX TO TWELVE YEAR OLD CHILDREN: A CROSS SECTIONAL STUDY |
| Trial Acronym |
DA & OHRQoL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SEJAL BHUTADA |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
Y.M.T DENTAL COLLEGE AND HOSPITAL |
| Address |
ROOM NUMBER 21,SECOND FLOOR DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY, Y.M.T DENTAL COLLEGE AND HOSPITAL , SECTOR-04,KHARGHAR,NAVI MUMBAI
Raigarh
MAHARASHTRA
410210
India |
| Phone |
7038297838 |
| Fax |
|
| Email |
bhutadasejal496@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR AMAR KATRE |
| Designation |
PROFESSOR AND HEAD OF THE DEPARTMENT |
| Affiliation |
Y.M.T DENTAL COLLEGE AND HOSPITAL |
| Address |
ROOM NUMBER 21,SECOND FLOOR DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY, Y.M.T DENTAL COLLEGE AND HOSPITAL , SECTOR-04,KHARGHAR,NAVI MUMBAI
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9821540186 |
| Fax |
|
| Email |
amar_katre@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SEJAL BHUTADA |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
Y.M.T DENTAL COLLEGE AND HOSPITAL |
| Address |
ROOM NUMBER 21,SECOND FLOOR DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY, Y.M.T DENTAL COLLEGE AND HOSPITAL , SECTOR-04,KHARGHAR,NAVI MUMBAI
Raigarh
MAHARASHTRA
410210
India |
| Phone |
7038297838 |
| Fax |
|
| Email |
bhutadasejal496@gmail.com |
|
|
Source of Monetary or Material Support
|
| MONETARY SUPPORT SELF SUPPORT BY DR SEJAL BHUTADA AND INFRASTRUCTURAL SUPPORT BY ROOM NUMBER 21, SECOND FLOOR DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY,Y.M.T DENTAL COLLEGE AND HOSPITAL , SECTOR -04 KHARGHAR, NAVI MUMBAI |
|
|
Primary Sponsor
|
| Name |
DR SEJAL BHUTADA |
| Address |
ROOM NUMBER 21,SECOND FLOOR DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY, Y.M.T DENTAL COLLEGE AND HOSPITAL , SECTOR-04, KHARGHAR NAVI MUMBAI, RAIGARH, MAHARASHTRA-410210 INDIA |
| Type of Sponsor |
Other [SELF SUPPORT] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DR AMAR KATRE |
ROOM NUMBER 21,SECOND FLOOR DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY, Y.M.T DENTAL COLLEGE AND HOSPITAL , SECTOR-04, KHARGHAR NAVI MUMBAI, RAIGARH, MAHARASHTRA-410210 INDIA |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR SEJAL BHUTADA |
Y.M.T DENTAL COLLEGE AND HOSPITAL |
ROOM NUMBER 21,SECOND FLOOR DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY,Y.M.T. DENTAL COLLEGE AND HOSPITAL,SECTOR -04,KHARGHAR, NAVI MUMBAI
Raigarh
MAHARASHTRA |
7038297838
bhutadasejal496@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: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
HEALTHY CHILDREN BETWEEN SIX TO TWELVE YEARS OF AGE |
|
| ExclusionCriteria |
| Details |
1. CHILDREN WHO ARE PHYSICALLY OR MENTALLY HANDICAPPED AND/OR MEDICALLY COMPROMISED.
2. CHILDREN WHO HAD PAST DENTAL HISTORY.
3. CHILDREN WHOSE GENERAL CONDITIOND INTERFERES WITH EXAMINATION AND DATA COLLECTION.
4. CHILDREN WHOSE PARENTS REFUSE 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 RELATED QUALITY OF LIFE |
AT BASELINE |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| CARIES AND CARIES STATUS |
AT BASELINE |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
01/06/2021 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
DENTAL FEAR AND ANXIETY IN CHILDREN HAS BEEN REPORTED AS ONE OF MOST IMPORTANT REASONS FOR AVOIDANCE AND NEGLIGENCE OF REGULAR DENTAL CARE WHICH OVER TIME RESULTS IN DETERIORATED ORAL HEALTH.AND THEIR BY HAVE AN IMPACT ON OHRQoL.IN THIS STUDY 200 CHILDREN WILL BE RECRUITED FOR ASSESSING DENTAL ANXIETY AND OHRQoL BY EXAMINATION AND THROUGH QUESTIONNAIRE . THERE BY ASSOCIATION BETWEEN DENTAL ANXIETY AND OHRQoL WILL BE ASSESSED.
|