| CTRI Number |
CTRI/2022/10/046308 [Registered on: 10/10/2022] Trial Registered Prospectively |
| Last Modified On: |
03/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
RELATIONSHIP BETWEEN PARENT REPORTED CHILDS GENERAL ANXIETY, CHILDS SELF REPORTED DENTAL ANXIETY AND DENTISTS ASSESMENT OF CHILDS DENTAL ANXIETY IN THREE TO SIX YEAR OLD CHILDREN |
|
Scientific Title of Study
|
CORRELATION BETWEEN PARENTAL PERCEPTION OF CHILD’S GENERAL ANXIETY, CHILD’S DENTAL ANXIETY AND OPERATOR’S RATING OF CHILD’S DENTAL ANXIETY IN THREE TO SIX 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 PRAJAKTA PARESH PATWARDHAN |
| Designation |
POSTGRADUATE STUDENT |
| Affiliation |
DR. G. D. POL FOUNDATIONS YMT DENTAL COLLEGE AND HOSPITAL, KHARGHAR, NAVI MUMBAI |
| Address |
DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY, ROOM NO. 21, SECOND FLOOR, YMT DENTAL COLLEGE, NAVI MUMBAI
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8007595207 |
| Fax |
|
| Email |
pppatwardhan86@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SUBHADRA H N |
| Designation |
PROFESSOR |
| Affiliation |
DR. G. D. POL FOUNDATIONS YMT DENTAL COLLEGE AND HOSPITAL, KHARGHAR, NAVI MUMBAI |
| Address |
DR G D POL FOUNDATIONS YMT DENTAL COLLEGE AND HOSPITAL, KHARGHAR, NAVI MUMBAI
Ratnagiri
MAHARASHTRA
410210
India |
| Phone |
9870818852 |
| Fax |
|
| Email |
drsubhadrahn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PRAJAKTA PARESH PATWARDHAN |
| Designation |
POSTGRADUATE STUDENT |
| Affiliation |
DR. G. D. POL FOUNDATIONS YMT DENTAL COLLEGE AND HOSPITAL, KHARGHAR, NAVI MUMBAI |
| Address |
DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY, ROOM NO. 21, SECOND FLOOR, YMT DENTAL COLLEGE AND HOSPITAL, NAVI MUMBAI.
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8007595207 |
| Fax |
|
| Email |
pppatwardhan86@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR PRAJAKTA PARESH PATWARDHAN |
| Address |
DR. G. D. POL FOUNDATIONS YMT 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 PRAJAKTA PARESH PATWARDHAN |
DR. G. D. POL FOUNDATIONS YMT DENTAL COLLEGE AND HOSPITAL |
DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY, ROOM NO. 21, SECOND FLOOR.
Raigarh
MAHARASHTRA |
8007595207
pppatwardhan86@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 |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
General and Dental anxiety |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy children between three to six years of age and their mothers. |
|
| ExclusionCriteria |
| Details |
1. Children who are physically or mentally challenged and/or medically compromised.
2. Children who have past dental history.
3. Children and their mothers whose general condition interferes with examination and data collection.
4. Children and their mothers who have experienced anything psychologically traumatic (e.g., severe accident, death of a family member/friend, assault, robbery, disaster)
5. Children whose parents refuse to give consent.
Dental |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Parental perception of child’s general anxiety (measured using Preschool anxiety scale)
2. Operator’s rating of child’s dental anxiety (measured using Venham’s clinical anxiety scale)
3. Child’s dental anxiety (measured using CFSS-DS scale) |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Socioeconomic status (recorded using modified Kuppuswamy scale)
2. Maternal education (recorded using subscale of modified Kuppuswamy scale) |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="733"
Sample Size from India="733"
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)
|
15/10/2022 |
| 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 correlation between parental perception of child’s general anxiety, child’s dental anxiety and operator’s rating of child’s dental anxiety in three to six year old children. Other hypothesis : 1. There is an effect of socioeconomic status on parental perception of child’s general anxiety and child’s dental anxiety. 2. There is an effect of maternal education on parental perception of child’s general anxiety and child’s dental anxiety. |