| CTRI Number |
CTRI/2025/04/085477 [Registered on: 23/04/2025] Trial Registered Prospectively |
| Last Modified On: |
19/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
IN PURSUIT OF PRECISION DIGITAL AND CONVENTIONAL IMPRESSIONS IN PEDIATRIC DENTISTRY |
|
Scientific Title of Study
|
In Pursuit of Precision Digital vs Conventional Impressions in Pediatric Dentistry |
| Trial Acronym |
Randomised Clinical Trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shrusti Shah |
| Designation |
|
| Affiliation |
Narsinhbhai Patel Dental College Hospital |
| Address |
Department no 8 Pediatric and Preventive Dentistry, Narsinhbhai Patel Dental College and Hospital, SPU, Visnagar
Mahesana
GUJARAT
384315
India |
| Phone |
7990160037 |
| Fax |
|
| Email |
shrusti0699@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shoba Fernandes |
| Designation |
Professor and Head Of Department |
| Affiliation |
Narsinhbhai Patel Dental College Hospital |
| Address |
Department no 8 Department of Pediatric and Preventive Dentistry
Mahesana
GUJARAT
384315
India |
| Phone |
09429386118 |
| Fax |
|
| Email |
Vshobaf@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shoba Fernandes |
| Designation |
Professor and Head Of Department |
| Affiliation |
Narsinhbhai Patel Dental College Hospital |
| Address |
Department no 8 Department of Pediatric and Preventive Dentistry
Mahesana
GUJARAT
384315
India |
| Phone |
09429386118 |
| Fax |
|
| Email |
Vshobaf@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department no 8, Narsinhbhai Patel Dental College and Hospital, SPU, Visnagar, Mehsana, Gujarat |
|
|
Primary Sponsor
|
| Name |
Narsinhbhai Patel Dental College & Hospita |
| Address |
S. P. Sahakar Vidyadham Ambaji Gandhinagar Link Road Near Kamana Char Rasta Visnagar Gujarat 384315 |
| Type of Sponsor |
Private medical college |
|
|
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 Shoba Fernandes |
Department no. 8, Department of Pediatric & Preventive Dentistry |
NARSHIBHAI DENTAL COLLEGE AND HOPISTIAL Sankalchand Patel University Visnagar, Gujarat
Mahesana
GUJARAT |
7567622346
shrusti0699@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (|EC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K051||Chronic gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Alginate Impression |
Alginate is a flexible and irreversible hydrocolloid impression material that has been used in dentistry for many years. Alginate impression materials are easy to use, capture fine detail and are cost-effective compared to similar elastic impressions. Alginates are very hydrophilic and tend to absorb water or moisture, resulting in dimensional changes. However, their low viscosity can cause a vomiting reflex in patients |
| Intervention |
Intra Oral Scanners (IOSs) Impression |
Intra Oral Scanners (IOSs) are becoming increasingly popular as digital technology has become widely available in the field of dentistry. There are benefits to using intraoral scanners for digital impressions. They can help simplify laboratory procedures such as dental cast fabrication and improve communication between dentists and dental technicians/patients. Intraoral scanners have their own image acquisition technology. Digital impressions obtained using intraoral scanners are also being adapted in the field of Pediatric dentistry |
|
|
Inclusion Criteria
|
| Age From |
3.00 Day(s) |
| Age To |
10.00 Day(s) |
| Gender |
Both |
| Details |
Patients should be caries free. |
|
| ExclusionCriteria |
| Details |
Children with special health care conditions
Teeth with mobility
If any teeth are in active eruption phase
Malocclusion present in patient
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Digital Impression will have less chairside time and more accuracy when compared to conventional Alginate impression techqnique |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Likert scale may show more patient satisfaction with Digital impression technique |
6 months |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "25"
Final Enrollment numbers achieved (India)="25" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/05/2025 |
| Date of Study Completion (India) |
11/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Scope
Volume 15 Number 03 September 2025 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Impression are used to replicate the teeth and surrounding oral structures by creating a dental impression to fabricate a dental cast. This strategy gives a tri-dimensional and exact mouth copy, permitting dental work indeed within the nonappearance of the understanding. The use of dental models enables dentists to perform better and more distant tasks, as well as improve their determination Two techniques Digital and Conventional Alginate impression technique will be used to check patient satisfaction and accuracy of the same |