| 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
|
|
|
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
|
|
|
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. |