| CTRI Number |
CTRI/2026/04/109028 [Registered on: 21/04/2026] Trial Registered Prospectively |
| Last Modified On: |
10/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing two tooth-colored crowns for restoring decayed front baby teeth in children aged 3–5 years based on gum health, deposits around the crowns, stability and roughness |
|
Scientific Title of Study
|
Comparative assessment of two Aesthetic Full-Coverage Crowns for carious primary anterior teeth in children: A Randomized 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 |
Nikhitha C V |
| Designation |
Postgratuate studeny |
| Affiliation |
SRM Kattankulathur Dental College |
| Address |
SRM Kattankulathur Dental College, Potheri, SRM Nagar, Kattankulathur, Tamil Nadu 603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7305883096 |
| Fax |
|
| Email |
nikhi.2608@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kavitha Ramar |
| Designation |
Professor and head of department of pediatric and preventive dentistry |
| Affiliation |
SRM Kattankulathur Dental College |
| Address |
SRM Kattankulathur Dental College, Potheri, SRM Nagar, Kattankulathur, Tamil Nadu 603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9884837586 |
| Fax |
|
| Email |
kavithar2@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Nikhitha C V |
| Designation |
Postgraduate student |
| Affiliation |
SRM Kattankulathur Dental College |
| Address |
SRM Kattankulathur Dental College, Potheri, SRM Nagar, Kattankulathur, Tamil Nadu 603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7305883096 |
| Fax |
|
| Email |
nikhi.2608@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM Kattankulathur Dental College, SRM Nagar, Kattankulathur Chengalpettu district, Tamil Nadu 603203 |
|
|
Primary Sponsor
|
| Name |
SRM Kattankulathur Dental College |
| Address |
Department of Pediatric and Preventive Dentistry, SRM Kattankulathur Dental College, SRM Nagar, Kattankulathur Chengalpettu district, Tamil Nadu 603203 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Nikhitha CV |
SRM Kattankulathur Dental College |
Room no 109, Department of Pediatric and Preventive Dentistry, SRM Kattankulathur Dental College, SRM Nagar, Kattankulathur, Tamil Nadu 603203
Kancheepuram
TAMIL NADU |
7305883096
nikhi.2608@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Institutional ethics committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K02||Dental caries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Celluloid crowns |
Celluloid crowns are transparent, preformed, resin-filled shells used in pediatric dentistry for aesthetics and full coronal restoration of primary anterior teeth. |
| Intervention |
Composite crowns |
A composite crowns are tooth-colored dental restoration made from a mixture of acrylic resin and glass particles |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
1. Children aged 3 to 5 years old.
2. No history of systemic illness.
3. Patient with early childhood caries as defined by AAPD,2016. |
|
| ExclusionCriteria |
| Details |
1. Teeth with proximity to exfoliation and resorption of root passed its half.
2. Presence of single surface caries not involving the proximal surfaces.
3. Children with special health needs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the gingival health, plaque accumulation, retention, and surface roughness of
carious primary anterior teeth restored with two Aesthetic Full-Coverage Crowns. |
Time point 1 - baseline
Time point 2 - 1st month
Time point 3 - 3rd month
Time point 4 - 6th month
Time point 5 - 12th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the gingival health, plaque accumulation, retention, and surface roughness of
carious primary anterior teeth restored with two Aesthetic Full-Coverage Crowns. |
Time point 1 - baseline
Time point 2 - 1st month
Time point 3 - 3rd month
Time point 4 - 6th month
Time point 5 - 12th month |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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 2 |
|
Date of First Enrollment (India)
|
01/05/2026 |
| 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="1"
Months="8"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Data are available indefinitely at (Link to be included nikhi.2608@gmail.com).
- For how long will this data be available start date provided 01-04-2026 and end date provided 01-11-2027?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This randomized controlled trial aims to compare the clinical performance of two aesthetic full-coverage crowns - celluloid crowns and prefabricated composite crowns, in the management of carious primary maxillary anterior teeth in children aged 3–5 years with Early Childhood Caries. The primary outcomes assessed will include gingival health, plaque accumulation, retention, and surface roughness using established clinical indices. While celluloid crowns are considered the gold standard, they are technique-sensitive, whereas composite crowns offer easier handling and standardized morphology; however, comparative evidence is limited. This study hypothesizes that there may be a significant difference in clinical performance between the two crown types and aims to identify the most effective, esthetic, and child-friendly restorative option for primary anterior teeth. A total of 34 primary maxillary anterior teeth will be randomly allocated into two groups (n=17 each) using simple randomization with allocation concealment. Standardized tooth preparation and crown placement procedures will be carried out, followed by evaluations at baseline,1, 3, 6, and 12 months. |