FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/03/083441 [Registered on: 26/03/2025] Trial Registered Prospectively
Last Modified On: 25/03/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   The influence of parental presence on childrens behaviour in dental operatory.  
Scientific Title of Study   Influence of parental presence on childrens behaviour in dental operatory.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Priya Gore 
Designation  Postgraduate student 
Affiliation  Padmashree Dr. D.Y. Patil Dental College and Hospital Navi Mumbai 
Address  oom No. 0 Department of Pediatric and Preventive Dentistry (Basement) D Y Patil University School of Dentistry D Y Patil Vidyanagar Sector 7 Nerul Navi Mumbai 400706 Maharashtra India

Mumbai
MAHARASHTRA
400706
India 
Phone  9764836190  
Fax    
Email  priyagore41@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jasmin Winnier 
Designation  Associate professor 
Affiliation  Padmashree Dr. D.Y. Patil Dental College and Hospital Navi Mumbai 
Address  Room No. 0 Department of Pediatric and Preventive Dentistry (Basement) D Y Patil University School of Dentistry D Y Patil Vidyanagar Sector 7 Nerul Navi Mumbai

Mumbai
MAHARASHTRA
400706
India 
Phone  9773284371  
Fax    
Email  jasmin.winnier@dypatil.edu  
 
Details of Contact Person
Public Query  
Name  Dr Jasmin Winnier 
Designation  Postgraduate student 
Affiliation  Padmashree Dr. D.Y. Patil Dental College and Hospital Navi Mumbai 
Address  Room No. 0 Department of Pediatric and Preventive Dentistry (Basement) D Y Patil University School of Dentistry D Y Patil Vidyanagar Sector 7 Nerul Navi Mumbai

Mumbai
MAHARASHTRA
400706
India 
Phone  9773284371  
Fax    
Email  jasmin.winnier@dypatil.edu  
 
Source of Monetary or Material Support  
D.Y.Patil university School of Dentistry,Navi Mumbai. 
 
Primary Sponsor  
Name  Department of Pediatric and Preventive dentistry 
Address  D.Y.Patil university School of Dentistry, Dr.D.Y.Patil Vidyanagar, Sector 7, nerul, Navi Mumbai. 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Priya Jayant Gore  D.Y.Patil University school of Dentistry  Room No. 0 Department of Pediatric and Preventive Dentistry (Basement) D Y Patil Vidyanagar Sector 7 Nerul Navi Mumbai Thane MAHARASHTRA 400706 India
Thane
MAHARASHTRA 		 9764836190

priyagore41@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional research and ethical board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Parents absent during the dental treatment   The dental treatment of children will be carried out without presence of parents in the operatory 
Intervention  parents present at the time of treatment procedure   Presence of any one parent during dental treatment of children for 30-60 mins 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  1. Children of age 4yrs to 6yrs requiring alike treatment sessions.
2. Children undergoing treatment with local anesthesia.
3. Lack of any systemic disease or any psychiatric disorder (ADHD, phobia, etc)
4. Children without any history of previous hospitalization.
5. Lack of any psycho-pathological familial history (including the addiction of a parent, divorce, familial violence, and child abuse).
 
 
ExclusionCriteria 
Details  1. Children with psychological development delays and learning disabilities.
2. Children who needed emergency dental treatments.
3. Children whose parents did not provide their consent for the study.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
anxiety and behaviour of children.
increased or decreased heart rate associated with dental anxiety. 		 baseline 
 
Secondary Outcome  
Outcome  TimePoints 
parental satisfaction
success of treatment  		 baseline 
 
Target Sample Size   Total Sample Size="74"
Sample Size from India="74" 
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)   07/04/2025 
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="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Aim and objective: Successfully managing the behavioural resistance of preschool children is an essential component of providing high-quality pediatric dental care. According to the literature, the presence of parents during treatment significantly impacts the behaviour of children. The current study aims to evaluate the impact of parental presence on children’s behaviour and anxiety in dental operatory.

Methodology: The study was conducted on 74 children of 4-6 years undergoing various dental procedures. Children were selected according to inclusion criteria and randomly divided into two subgroups. Group I included those whose parents were present; while Group II included children whose parents were absent during the treatment procedure. The behaviour of children was recorded using the Frankl behaviour rating scale and facial image scale (FIS) and the highest heartbeat was recorded using a finger pulse oximeter at the time of the procedure.

 
Close