| CTRI Number |
CTRI/2022/10/046939 [Registered on: 31/10/2022] Trial Registered Prospectively |
| Last Modified On: |
28/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
TOOTH DECAY AND ITS RELATION WITH MENTAL DEPRESSION IN CHILDREN |
|
Scientific Title of Study
|
ASSESSMENT OF DENTAL CARIES STATUS AND ITS ASSOCIATION WITH MENTAL DEPRESSION IN TWELVE TO EIGHTEEN YEAR-OLD CHILDREN: 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 VIDYA DADA BAGUL |
| Designation |
POSTGRADUATE STUDENT |
| Affiliation |
Dr. G.D.POL FOUNDATIONS Y.M.T. DENTAL COLLEGE AND HOSPITAL,KHARGHAR,NAVI MUMBAI |
| Address |
DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY, SECOND FLOOR, DEPARTMENT NO. 21
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9833200449 |
| Fax |
|
| Email |
bagul.vidya08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR AMAR KATRE |
| Designation |
HEAD OF DEPARTMENT |
| Affiliation |
Dr. G.D.POL FOUNDATIONS Y.M.T. DENTAL COLLEGE AND HOSPITAL,KHARGHAR,NAVI MUMBAI |
| Address |
Dr. G.D.POL FOUNDATIONS Y.M.T. DENTAL COLLEGE AND HOSPITAL, KHARGHAR, NAVI MUMBAI
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9821540186 |
| Fax |
|
| Email |
amar_katre@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR VIDYA DADA BAGUL |
| Designation |
POSTGRADUATE STUDENT |
| Affiliation |
Dr. G.D.POL FOUNDATIONS Y.M.T. DENTAL COLLEGE AND HOSPITAL,KHARGHAR,NAVI MUMBAI |
| Address |
DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY, SECOND FLOOR, DEPARTMENT NO. 21
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9833200449 |
| Fax |
|
| Email |
bagul.vidya08@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR VIDYA DADA BAGUL |
| Address |
DR. G.D. POL FOUNDATIONS Y.M.T. DENTAL COLLEGE AND HOSPITAL,SECTOR-4,KHARGHAR, NAVI MUMBAI |
| 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 VIDYA DADA BAGUL |
DR. G.D. POL FOUNDATIONS Y.M.T. DENTAL COLLEGE AND HOSPITAL |
DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY, ROOM NO.21, SECOND FLOOR.
Raigarh
MAHARASHTRA |
9833200449
bagul.vidya08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Y. M. T. Dental College And Hospital, Kharghar |
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 |
12.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Healthy children between twelve to eighteen years of age. |
|
| ExclusionCriteria |
| Details |
1. Children with uncontrolled systemic illness.
2. Children who are physically challenged and/or medically compromised.
3. Children whose general condition 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 |
1. Depression (measured using PHQ-9 Scale)
2. Dental Caries (measured using DMFT)
|
BASELINE |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Frequency of free sugar consumption |
BASELINE |
|
|
Target Sample Size
|
Total Sample Size="420"
Sample Size from India="420"
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)
|
01/11/2022 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Primary Hypothesis : There is a positive association of dental caries status with mental depression in twelve to eighteen year old children. Other Hypothesis : Frequency of free sugar consumption has an effect on the association of dental caries status with mental depression in twelve to eighteen year old children. |