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Enrolling by Invitation

NCT Number: NCT07519382

Comparing the Clinical Success of Two Different 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.

Enrolling by Invitation

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Key information

Conditions

Tooth Decay Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Semmelweis University, Department of Restorative Dentistry and Endodontics

Budapest, 1088, Hungary

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

full cuspal covarage onlay

Device

Composite onlays prepared with CAD/CAM technology

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Semmelweis University

Other

Registry information

Official study title

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

Acronym: CUSTOM

Important dates

Study start
2026
Primary completion
2036
Study completion
2036
First posted
Apr 9, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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