| CTRI Number |
CTRI/2026/03/106761 [Registered on: 23/03/2026] Trial Registered Prospectively |
| Last Modified On: |
23/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparision of mechanical and functional performance of 3D printed crowns for primary molars. |
|
Scientific Title of Study
|
Comparative evaluation of mechanical and functional efficacy of 3D printed polymethylmethacrylate (PMMA) crown with zirconia and silica nanoparticles for restoration of deciduous molars |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sujatha P |
| Designation |
PhD scholar |
| Affiliation |
Sharad Pawar Dental College,Datta Meghe Institute of Higher Education and Research. Wardha |
| Address |
Department of Pedodontics,Sharad Pawar Dental College,Datta Meghe Institute of Higher Education and Research,Sawangi(Meghe)
Wardha
MAHARASHTRA
442107
India |
| Phone |
7259215556 |
| Fax |
|
| Email |
drsuji912@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nilima Thosar |
| Designation |
Professor and Head, PhD guide |
| Affiliation |
Sharad Pawar Dental College,Datta Meghe Institute of Higher Education and Research. Wardha |
| Address |
Department of Pedodontics,Sharad Pawar Dental College,Datta Meghe Institute of Higher Education and Research,Sawangi(Meghe)
Wardha
MAHARASHTRA
442107
India |
| Phone |
|
| Fax |
|
| Email |
drnthosar@rediffnail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sujatha P |
| Designation |
PhD scholar |
| Affiliation |
Sharad Pawar Dental College,Datta Meghe Institute of Higher Education and Research. Wardha |
| Address |
Department of Pedodontics,Sharad Pawar Dental College,Datta Meghe Institute of Higher Education and Research,Sawangi(Meghe)
Wardha
MAHARASHTRA
442107
India |
| Phone |
7259215556 |
| Fax |
|
| Email |
drsuji912@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pedodontics
Sharad Pawar Dental Colege and Hopsital, Datta Meghe Institute of Higher Education and Research, Sawangi,
Wardha 442107, Maharashtra
|
|
|
Primary Sponsor
|
| Name |
Department of Pediatric and Preventive Dentistry |
| Address |
Sharad Pawar Dental College and Hospital, Datta Meghe Institute of Higher Education and Research, Sawangi, Wardha 442207, Maharashtra |
| 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 |
| Dr Sujatha P |
Department of Pediatric and Preventive Dentistry,Sharad Pawar Dental College and Hospital |
Department of Pediatric and Preventive Dentistry, Sharad Pawar Dental College and Hospital, Datta Meghe Institute of Higher Education and Research,Sawangi,Wardha, 442107, Maharashtra, India
Wardha
MAHARASHTRA |
8618557518
drsuji912@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Dental Caries |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
3D printed Polymethylmethacrylate crown with zirconia nanoparticles |
3D printed Polymethylmethacrylate crown with zirconia nanoparticles will be evaluated for functional and mechanical efficacy of the crown at one ,three and six months frequency.Duration of intervention is six months. |
| Comparator Agent |
3D printed Polymethylmethacylate crown with silica nanoparticles |
3D printed Polymethylmethacylate crown with silica nanoparticles will be compared with 3D printed PMMA crown with ziconia nanoparticles for functional and mechanical efficacy at one ,three and six months frequency.Duration of intervention is six months. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
Requiring crown on the deciduous teeth
Pulpectomy treated tooth
Pulpotomy treated tooth |
|
| ExclusionCriteria |
| Details |
Grossly decayed tooth
Tooth near to exfoliation
Tooth with patholigical root resorption |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Gingival health of tooth
wear resistance of opposing tooth |
Development of 3d printed PMMA crown for deciduous tooth |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
N/A |
|
Date of First Enrollment (India)
|
09/04/2026 |
| 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
|
Background: Stainless steel crown is successfully used to treat the deciduous teeth. Zirconia crowns are esthetic but are expensive, more tooth preparation and technique sensitive. The recent technology has lead to 3D printing of polmethylmethacrylate (PMMA). Hence, the purpose is to develop and compare the mechanical and functional efficacy of 3D print PMMA crown with zirconia and silica nanoparticles. Novelty: The 3D print PMMA crown is printed with newer technology. An economical esthetic crown for treatment of deciduous teeth. Objectives: To evaluate and compare the mechanical and functional efficacy of 3D print PMMA crown with zirconia and silica nanoparticles. Methods: In Vivo study After obtaining informed consent, twenty patients will be randomly allocated into two groups with 10 each group. After tooth preparation and cementation, the performance of the crown will be evaluated for retentivity, gingival response and wear of opposing tooth at one, three and six month follow-up. Appropriate statistical analysis will be applied. |