| CTRI Number |
CTRI/2025/07/091357 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
21/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A Study Comparing Digital and Conventional Dental Impressions in Children |
|
Scientific Title of Study
|
Comparative evaluation of digital and conventional impression methods in pediatric patients: A randomized crossover 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 |
Dr Saumya Jose |
| Designation |
Post Graduate Student |
| Affiliation |
Christian Dental College |
| Address |
Department of Pediatric and Preventive Dentistry,
Room No 8,
Christian Dental College,
Brown Rd, CMC Campus, Ludhiana
Ludhiana
PUNJAB
141008
India |
| Phone |
9075656707 |
| Fax |
|
| Email |
saumyajosecdc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ruchika Kundra |
| Designation |
Associate Professor |
| Affiliation |
Christian Dental College |
| Address |
Department of Pediatric and Preventive Dentistry,
Room No 8
Christian Dental College,
Brown Rd, CMC Campus, Ludhiana
Ludhiana
PUNJAB
141008
India |
| Phone |
9855966788 |
| Fax |
|
| Email |
rkundra4@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Mebin George Mathew |
| Designation |
Associate Professor |
| Affiliation |
Christian Dental College |
| Address |
Department of Pediatric and Preventive Dentistry
Room No 8,
Christian Dental College,
Brown Rd, CMC Campus,Ludhiana
Ludhiana
PUNJAB
141008
India |
| Phone |
8951748659 |
| Fax |
|
| Email |
mebingmathew@gmail.com |
|
|
Source of Monetary or Material Support
|
| Christian Dental College, Ludhiana |
|
|
Primary Sponsor
|
| Name |
Dr Saumya Jose |
| Address |
Christian Dental College,
Brown Rd, CMC Campus,Ludhiana- 141008, Punjab, India |
| Type of Sponsor |
Other [] |
|
|
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 Saumya Jose |
Christian Dental College |
Department of Pediatric and Preventive Dentistry, Room No 8, Brown Rd, CMC Campus, Ludhiana
Ludhiana
PUNJAB |
9075656707
saumyajosecdc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Biomedical and Health Research, Christian Medical College and Hospital, Ludhiana |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Malocclusion |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Alginate Impression |
Conventional impression will be taken using Impreceed Alginate (Impreceed,GC Corporation, Japan). Impression material according to the manufacturers instructions. The alginate is hand-mixed with water. The operator will hand- mixed the
alginate, take the upper impression and second operator will register the impression time. The impressions will be poured by type III gypsum. |
| Intervention |
Digital Impression |
The digital impression will be made with the intraoral
optical scanner (dfine intraorla scanner, Dentcare Lab, Kerala, India) following the procedure reported by the manufacturer. In the upper arch, the occlusal, buccal and palatal surfaces will be
scanned in sequence. Another operator will register the impression time. |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1. A healthy child with no significant medical history
2. Child aged 7-14 years
3. Patients with fully erupted maxillary permanent first molars and
presence of maxillary canines which are caries free, not restored and
without any anomalies.
4. Patients with no previous experience with digital intraoral scan or
alginate impression technique
5. Patients in need of treatment with removable orthodontic appliances
6. Patients in need of dental treatment, excluding fixed orthodontic appliance therapy
7. Children whose parents or guardians gave consent |
|
| ExclusionCriteria |
| Details |
1. Non-compliant patients
2. Patients with syndromes or systemic diseases
3. Patients suffering from cleft lip and palate
4. Patients with fixed appliance
5. Children whose parents or guardians did not give consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare comfort between conventional and digital impression in children |
At baseline and at 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare physiologic response between conventional & digital
impression in children |
1. At baseline
2. After 2 weeks |
| To compare accuracy in conventional & digital impression in children |
1. At baseline
2. After 2 weeks |
To compare time taken for conventional & digital impression in
children |
1. At baseline
2. After 2 weeks |
To compare preference between conventional & digital impression
in children |
1. At baseline
2. After 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 4 |
|
Date of First Enrollment (India)
|
18/08/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
In pediatric dentistry, dental impressions are fundamental for diagnostic
assessment and treatment planning, particularly in managing the
growing orthodontic needs of children. Conventional impressions often
cause discomfort, gagging, TMJ pain and anxiety, making cooperation
difficult. They also carry technical drawbacks such as distortion and long
setting times. Digital impressions using intraoral scanners offer an
alternative by generating 3D images of the dentition and reducing lab
work. However, in children aged 7–14, factors like smaller oral cavities,
mixed dentition, and limited access to posterior areas may affect their
accuracy. Stress during dental procedures can lead to increased heart
rate, rapid breathing, and reduced oxygen saturation—physiological
changes influenced by anxiety and fear. While previous studies have
focused on preferences and procedural time, few have assessed these
objective stress indicators This study aims to bridge these gaps by
comprehensively comparing digital and conventional providing clinically
relevant insights to enhance pediatric dental care
A randomized crossover study will be conducted on 40 participants,
each receiving both conventional and digital impressions, with a one
week washout period between procedures. Block randomization will
determine the order of procedures, with allocations concealed in sealed,
opaque envelopes which will be opened at the time of impression.
Conventional Alginate impressions of upper arch will be taken using
hand-mixed alginate and poured with type III gypsum. Digital
impressions of upper arch will be recorded using an intraoral scanner
following manufacturer guidelines. Chairside time will be recorded for
each method. Physiological responses—pulse rate and oxygen
saturation—will be recorded before, during, and after each procedure
using a wireless pulse oximeter. Maxillary arch distances will be
conducted using vernier calipers on the cast poured from the alginate
impression and digitally in the intraoral scanner via the software ruler,
with specific reference points. After both sessions, patient preference
will be recorded, and subjective feedback on pain, gag reflex, breathing
difficulty, and comfort will be assessed using the Wong-Baker FACES®
Scale. The results will be tabulated and statistically analysed |