| CTRI Number |
CTRI/2024/12/078510 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
18/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparative analysis of dental anxiety among children with communication difficulties and children with normal communication skills using doll placement test in miniature dental setup |
|
Scientific Title of Study
|
Assessment of Dental Anxiety Using Doll Placement Test in Miniature Dental Setup Among 3-7 years old Children with Verbal communication Challenges Compared to Children with Verbal communication skills |
| 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.D.Meera Fathima |
| Designation |
Postgraduate student |
| Affiliation |
The Tamilnadu Dr.MGR University |
| Address |
Department of Pediatrics and Preventive Dentistry,
Ragas Dental College and Hospital,
2/102,SH 49,
Uthandi
Chennai
Ragas Dental College and Hospital,
2/102,SH 49,Uthandi
Chennai
Chennai
TAMIL NADU
600119
India |
| Phone |
9790072295 |
| Fax |
|
| Email |
meeradivan2511@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.M.Jayanthi |
| Designation |
Head of the Department |
| Affiliation |
The Tamil Nadu Dr. M.G.R. Medical University |
| Address |
Department of Pediatrics and Preventive Dentistry,
Ragas Dental College and Hospital,
Uthandi
Chennai
69, Anna Salai, Little Mount, Guindy, Chennai, Tamil Nadu 600032
Chennai
TAMIL NADU
600119
India |
| Phone |
9840849850 |
| Fax |
|
| Email |
jayanthi_1963@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr.D.Meera Fathima |
| Designation |
PostGraduate student |
| Affiliation |
The Tamil Nadu Dr. M.G.R. Medical University |
| Address |
Department of Pediatrics and Preventive Dentistry,
Ragas Dental College and Hospital,
Uthandi
Chennai
69, Anna Salai, Little Mount, Guindy, Chennai, Tamil Nadu 600032
Chennai
TAMIL NADU
600119
India |
| Phone |
9790072295 |
| Fax |
|
| Email |
meeradivan2511@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatrics and Preventive Dentistry
Ragas Dental College and Hospital
2/102,SH 49, Uthandi
Chennai
Ragas dental college and hospital
Chennai-600119
Tamilnadu |
|
|
Primary Sponsor
|
| Name |
DMEERA FATHIMA |
| Address |
PostGraduate student
Ragas dental college and hospital,
2/102,SH 49, Uthandi
Chennai-600119
2/102,SH 49,uthandi |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrDMeera Fathima |
National Institute for Empowerment of Persons with Multiple Disabilities |
Room no:17
Department of Dental Clinic,
Kovalam, SH 49, Post, Muthukadu,603112
Tamilnadu
Chennai
TAMIL NADU |
9790072295
meeradivan2511@gmail.com |
| DrDMeera Fathima |
Ragas dental college and hospital |
Room no:5
Department of Pediatrics and Preventive Dentistry
Ragas dental college and hospital,
2-102 SH 49, Uthandi, Tamil Nadu 600119
Chennai
TAMIL NADU |
9790072295
meeradivan2511@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional review board,Ragas dental college and hospital |
Approved |
| National institute for Empowerment of Persons with Multiple Disabilities |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Screening for Dental caries in children of 3-7 years old |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
ack of communication skill children and normal communication children of 3-7 year old(group A,group B)
2. accompanying parent/guardian is one of the child’s primary caretaker and willing to participate in the study
3. the child accompany with the parent / guardian who can be a active communicator betwwn the child and the dentist |
|
| ExclusionCriteria |
| Details |
1. Children with discernable mental disorders
2. parents or children unwilling to participate in the study
3. children with dental emergencies
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Anxiety assessment with doll placement test |
Baseline assesment- same day (1 day) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Behaviour assessment with frankles behaviourrating scale |
Baseline behaviour assessment-same day(Same appointment) |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "82"
Final Enrollment numbers achieved (India)="82" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/01/2025 |
| Date of Study Completion (India) |
15/04/2025 |
| Date of First Enrollment (Global) |
14/01/2025 |
| Date of Study Completion (Global) |
15/04/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="3" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Fear and anxiety are the major obstacles in the management of Pediatric dental patients. The effective and efficient treatment depends on the alleviation of anxiety and fear of the child and developing trustworthy relationship with suggest the importance of pre-assessment of the fear and anxiety of the children, especially in children with lack of communication skill will become a major obstacle for a dentist during dental treatment. hence the present study was undertaken to compare and assess the anxiety among the children with lack of communicative skill compare to children with normal communicative skill using ‘DOLL PLACEMENT TEST’ in “MINIATURE DENTAL SETUP†|