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Enrolling by invitation NCT07519382

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

No phase Interventional Tooth Decay

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: full cuspal covarage onlay.
Who it may be relevant to
Registry conditions: Tooth Decay. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hungary
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • Device full cuspal covarage onlay
    Composite onlays prepared with CAD/CAM technology

Primary outcome measures

  • 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Hungary · 1 center
  • Semmelweis University, Department of Restorative Dentistry and Endodontics — Budapest

Publications

  • Sahin Z, Ozer NE, Yiotakiotaciota C, Kiotaliotacarslan MA. Mechanical Characteristics of Composite Resins Produced by Additive and Subtractive Manufacturing. Eur J Prosthodont Restor Dent. 2023 Aug 31;31(3):278-285. doi: 10.1922/EJPRD_2478Sahin08. PMID 37067049
  • Hickel R, Mesinger S, Opdam N, Loomans B, Frankenberger R, Cadenaro M, Burgess J, Peschke A, Heintze SD, Kuhnisch J. Revised FDI criteria for evaluating direct and indirect dental restorations-recommendations for its clinical use, interpretation, and reporting. Clin Oral Investig. 2023 Jun;27(6):2573-2592. doi: 10.1007/s00784-022-04814-1. Epub 2022 Dec 12. PMID 36504246
  • Alzraikat H, Burrow MF, Maghaireh GA, Taha NA. Nanofilled Resin Composite Properties and Clinical Performance: A Review. Oper Dent. 2018 Jul/Aug;43(4):E173-E190. doi: 10.2341/17-208-T. Epub 2018 Mar 23. PMID 29570020

Identifiers

NCT: NCT07519382 · BM/24614-1/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗