| CTRI Number |
CTRI/2025/03/082966 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Compare tooth caps prepared using a 3D printer and milling machines for the quality of fit and fracture strength. |
|
Scientific Title of Study
|
Clinical evaluation and comparison of 3D printed and milled indirect composite restoration a randomized clinical 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 |
Pallavi |
| Designation |
1st Year Post Graduate Student |
| Affiliation |
Yenepoya Dental College |
| Address |
Door no 2/325 new house paneer road ,near barsa home deralakatte mangaluru
University Road Deralakatte, Mangaluru - 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7004369758 |
| Fax |
|
| Email |
ppmadhav728@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hasan Sarfaraz |
| Designation |
Professor |
| Affiliation |
Yenepoya dental college |
| Address |
Dept of Prosthodontics and crown and Bridge yenepoya dental college , yenepoya university , university road
Deralakatte, mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9845083778 |
| Fax |
|
| Email |
drhsarfaraz@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pallavi |
| Designation |
1st Year Post Graduate Student |
| Affiliation |
Yenepoya Dental College |
| Address |
Door no 2/325 new house paneer road ,near barsa home deralakatte mangaluru
university road deralakatte mangaluru - 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7004369758 |
| Fax |
|
| Email |
ppmadhav728@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of prosthodontics crown and bridge ,1st basement no -1 Yenepoya dental college, yenepoya university, university road,deralakatte,mangalore,Dakshina Kannada,Karnataka ,575018 |
|
|
Primary Sponsor
|
| Name |
Pallavi |
| Address |
Dept of Prosthodontics and crown and Bridge, yenepoya dental college, university road ,deralakatte mangaluru ,karnataka 575018 |
| Type of Sponsor |
Other [Self] |
|
|
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 Pallavi |
Yenepoya dental college |
Department of Prosthodontics and crown and Bridge 1st basement , No -1 yenepoya dental college, yenepoya university, university road, Deralakatte,mangalore -575018
Dakshina Kannada
KARNATAKA |
7004369758
ppmadhav728@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya University Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CAD milled crown |
This crown will be fabricated using a pre-cured resin composite block and milled with a 5-axis milling machine. The restorations will be evaluated over one year using the Revised FDI Criteria (2022). |
| Intervention |
CAD printed crown |
This crown will be fabricated using a composite resin in a 3D printer, and the resin will be cured using digital light processing. The restorations will be evaluated over one year using the Revised FDI Criteria (2022). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who required post-endodontic restoration for molar teeth.
2. Presence of healthy natural antagonist tooth.
3.Tooth with at least 3 wall intact. |
|
| ExclusionCriteria |
| Details |
Periodontally compromised teeth
Patient with bruxism
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| We will identify the ideal material and the fabrication process for producing CAD CAM indirect composite restoration that will provide optimum long term functional and esthetic results. |
6 month and 12 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| We will assess the patient satisfaction and durability of the crown |
6 month and 12 month |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
03/04/2025 |
| 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="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 - NO
|
|
Brief Summary
|
This study is designed to clinically evaluate the performance of CAD CAM composite resin indirect restorations fabricated using two different manufacturing techniques. A total of 30 endodontically treated 1st Molar teeth will be prepared to receive Indirect Composite Restorations and will be divided into 2 groups with 15 prepared molars in each group. Tooth preparation will be done based on the ideal & minimally invasive tooth preparation principles. Digital Impression of the prepared teeth will be made with an intra-oral scanner (3 shape TRIOS 3). The scans obtained will be exported to EXOCAD a designing software for designing and fabrication of crowns using composite resin, 15 composite crowns will be 3D printed and 15 milled. Based on the Randomized patient chart these crowns will be delivered to the operator and cemented using the standard bonding protocols, thus, the clinician and patient will be blinded about the process being used for the fabrication of the crown. Clinical Evaluation will be done by using Revised FDI (2022) criteria, where it will be clinically evaluated on the day of restoration delivered (baseline), 6month and 1 year. |