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CTRI Number  CTRI/2026/03/106814 [Registered on: 24/03/2026] Trial Registered Prospectively
Last Modified On: 23/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Comparing Childrens Anxiety, Comfort and Time in Dental Impressions: Digital Scanning vs Traditional Method 
Scientific Title of Study   Comparative Evaluation of Anxiety, Comfort and Time taken during Paediatric Dental Impression Techniques : Digital Scanning vs Conventional Method - A Crossover Randomised Controlled Trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  CHARULEKHA Y 
Designation  Post Graduate 
Affiliation  Adhiparasakthi Dental College and Hopital 
Address  Room no:6, first floor, Department of Pediatric and Preventive dentistry, Adhiparasakthi Dental College and Hospital, Melmaruvathur

Kancheepuram
TAMIL NADU
603319
India 
Phone  8148786630  
Fax    
Email  charulekha602@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nisha M 
Designation  Assistant Professor 
Affiliation  Adhiparasakthi Dental College and Hopital 
Address  Room no:6, first floor, Department of Pediatric and Preventive dentistry, Adhiparasakthi Dental College and Hospital, Melmaruvathur

Kancheepuram
TAMIL NADU
603319
India 
Phone  9791430737  
Fax    
Email  drnishpedo@gmail.com  
 
Details of Contact Person
Public Query
 
Name  CHARULEKHA Y 
Designation  Post Graduate 
Affiliation  Adhiparasakthi Dental College and Hopital 
Address  Room no:6, first floor, Department of Pediatric and Preventive dentistry, Adhiparasakthi Dental College and Hospital, Melmaruvathur

Kancheepuram
TAMIL NADU
603319
India 
Phone  8148786630  
Fax    
Email  charulekha602@gmail.com  
 
Source of Monetary or Material Support  
Dental OPD in Adhiparasakthi Dental College and Hospital Room no:6, first floor, Department of Pediatric and Preventive dentistry, Adhiparasakthi Dental College and Hospital, Melamruvathur-603319, Tamilnadu, India 
 
Primary Sponsor  
Name  Dr Charulekha Y 
Address  Adhiparasakthi Dental College and Hopital Room no:6, first floor, Department of Pediatric and Preventive dentistry, Adhiparasakthi Dental College and Hospital, Melmaruvathur Kancheepuram TAMIL NADU 603319 India 
Type of Sponsor  Other [self funded] 
 
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 
DR CHARULEKHA Y  Adhiparasakthi Dental College and Hospital  Room no:6, first floor, Department of Pediatric and Preventive dentistry, Room no:6, first floor, Department of Pediatric and Preventive dentistry, Adhiparasakthi Dental College and Hospital, Melmaruvathur Kancheepuram TAMIL NADU 603319 India
Kancheepuram
TAMIL NADU 
8148786630

charulekha602@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board - Adhiparasakthi Dental College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Alginate Impression.  Alginate Impression is used to take upper and lower jaw impression. 
Intervention  Digital Intra Oral Scanner  Digital Intra Oral Scanning is used to take the upper and lower jaw impression. 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  Cooperative children in the 6–10 years age group.
Children not in treatment with fixed orthodontic appliance.
Parent/guardian consent obtained.
 
 
ExclusionCriteria 
Details  Children with systemic illness
Patients with syndromes or systemic diseases
History of allergy to impression materials
Extremely uncooperative patients
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The anxiety levels will be monitored with a pulse oximeter.   Outcome will be assessed at baseline. 
 
Secondary Outcome  
Outcome  TimePoints 
Patient comfort & gag reflex will be recorded immediately after the procedure using a Visual Analog Scale (VAS) & closed question respectively. The total time taken for each impression is measured in seconds using a stopwatch.  Outcome will be assessed at the baseline 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   30/04/2026 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

This study is a Randomised Controlled Trial conducted for 30 participants in a single institution. In the first appointment Group A – 15 children will undergo digital impressions using an intraoral scanner, while Group B – 15 children will undergo conventional impressions with alginate material. In the second appointment crossover is performed and the sequence is reversed.

To ensure consistency and eliminate operator bias, all procedures will be performed by the same clinician. 

Patient comfort, and gag reflex will be recorded immediately after the procedure using a Visual Analog Scale (VAS) and closed question respectively. The anxiety levels will be monitored with a pulse oximeter. The total time taken for each impression is measured in seconds using a stopwatch.

All impressions and subsequent measurements will be performed by the principal investigator, while an independent reviewer will observe the procedures to ensure adherence to the study protocol and to validate the accuracy of the data collection. The data collected will be subjected to statistical analysis using appropriate tests.

 
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