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Clinical Trials/CTRI/2025/03/082966
CTRI/2025/03/082966
Not yet recruiting
Phase 2/3

Clinical evaluation and comparison of 3D printed and milled indirect composite restoration a randomized clinical trial

Pallavi1 site in 1 country30 target enrollmentStarted: April 3, 2025Last updated:

Overview

Phase
Phase 2/3
Status
Not yet recruiting
Sponsor
Pallavi
Enrollment
30
Locations
1
Primary Endpoint
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.

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients who required post-endodontic restoration for molar teeth.
  • Presence of healthy natural antagonist tooth.
  • 3.Tooth with at least 3 wall intact.

Exclusion Criteria

  • Periodontally compromised teeth Patient with bruxism.

Outcomes

Primary Outcomes

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.

Time Frame: 6 month and 12 month

Secondary Outcomes

  • We will assess the patient satisfaction and durability of the crown(6 month and 12 month)

Investigators

Sponsor
Pallavi
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Pallavi

Yenepoya Dental College

Study Sites (1)

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