Comparing the Clinical Success of Two Different CAD/CAM Full Cuspal Coverage Onlays (CUSTOM)

April 8, 2026 updated by: Eszter Á Szalai, DMD, Semmelweis University

Comparing the Clinical Success of Milled and 3-D Printed Composite CAD/CAM Full Cuspal Coverage Onlays

This is a single-center, ten-year, randomized controlled, split-mouth clinical trial. A total of 164 adult patients requiring full-cuspal coverage onlays will be enrolled. Each participant will receive one milled and one 3-D printed restoration, randomly assigned.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Restorations will be evaluated at 1 week, 6 months, and 1-10 years using the revised FDI criteria for indirect restorations. The primary outcome is the survival rate of the onlays.

Study Type

Interventional

Enrollment (Estimated)

164

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
    • Budapest
      • Budapest, Budapest, Hungary, 1088
        • Semmelweis University, Department of Restorative Dentistry and Endodontics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • The presence of two teeth requiring restorative treatment (onlays) because of primary or secondary caries or final restoration is needed after root canal treatment, with adjacent and antagonist teeth
  • At least two walls (buccal and oral) with a minimum length of 2.5 mm and a width of 2 mm
  • The deepest point of the tooth structure should be above a minimum of 3 mm of supracrestal
  • The crown-to-root ratio is minimum 1:1

Exclusion Criteria:

  • Inadequate oral hygiene
  • Pregnancy
  • Allergies to restorative materials
  • Parafunctional habits (e.g., teeth grinding or clenching)
  • Presence of orthodontic appliances
  • Premolars that have undergone root canal treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Milled
Milled CAD/CAM composite restorations
Device: full cuspal covarage onlay
Composite onlays prepared with CAD/CAM technology
Experimental: 3D-printed
3-D printed CAD/CAM composite restorations
Device: full cuspal covarage onlay
Composite onlays prepared with CAD/CAM technology

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of survival of the onlays at the specific time points
Time Frame: Survival will be evaluated at specific follow-up time points (1 week, 6 months, 1 year - 10 years)
The survival of the onlays will be assessed at the patient level with the revised FDI criteria for direct and indirect restorations.
Survival will be evaluated at specific follow-up time points (1 week, 6 months, 1 year - 10 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Semmelweis University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 10, 2026

Primary Completion (Estimated)

April 18, 2036

Study Completion (Estimated)

December 10, 2036

Study Registration Dates

First Submitted

April 2, 2026

First Submitted That Met QC Criteria

April 2, 2026

First Posted (Actual)

April 9, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BM/24614-1/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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