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Clinical Evaluation of Additive and Subtractive Onlay Restorations

NCT07195201 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2025-09-26

No results posted yet for this study

Summary

The goal of this clinical trial is to learn whether onlay restorations produced by additive manufacturing \[three-dimensional (3D) printing\] and subtractive manufacturing \[Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM) milling\] perform equally well in vital posterior teeth. The main questions it aims to answer are:

* Do 3D printed onlay restorations show similar marginal adaptation and clinical performance compared to CAD/CAM milled onlays?
* Are there any differences in biological compatibility, surface properties, or postoperative sensitivity between the two techniques over time? Researchers will compare onlay restorations fabricated with 3D printing and CAD/CAM milling using a split-mouth study design.

Participants will:

* Receive one onlay restoration produced by 3D printing and another produced by CAD/CAM milling, placed on opposite sides of the mouth
* Have checkups at baseline (1st week), 6 months, 12 months, and 18 months after treatment
* Be evaluated using the Fédération Dentaire Internationale (FDI) criteria for marginal adaptation, surface quality, anatomical form, and biological compatibility

Conditions

  • CAD-CAM
  • Prospective Study
  • 3D Printing
  • Clinical Assessment

Interventions

DEVICE

3D Printed Onlay Restoration

Onlay restorations will be fabricated using a 3D printer and a biocompatible permanent resin (Bego VarseoSmile TriniQ). Digital intraoral scans will be used for design. Restorations will be placed in vital posterior teeth and evaluated at (1 week), 6 months, 12 months, and 18 months according to FDI criteria.

DEVICE

CAD/CAM Onlay Restoration

Onlay restorations will be fabricated using a CAD/CAM milling unit and hybrid ceramic blocks (GC Cerasmart 270). Digital intraoral scans will be used for design. Restorations will be placed in vital posterior teeth and evaluated at (1 week), 6 months, 12 months, and 18 months according to FDI criteria.

Sponsors & Collaborators

  • Mersin University

    collaborator OTHER

  • Ayse Tugba Erturk Avunduk

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-15
Primary Completion
2027-05-31
Completion
2027-08-31
FDA Device
Yes

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07195201 on ClinicalTrials.gov