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

NCT07519382 | Enrolling By Invitation DMC

• 1 other identifier: BM/24614-1/2025
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tooth Decay

Keywords

milling; 3-D printing; full-cuspal coverage onlay

Outcome Measures

Primary Outcomes (1)

• The rate of survival of the onlays at the specific time points

  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)

Study Arms (2)

Milled

ACTIVE COMPARATOR

Milled CAD/CAM composite restorations

Device: full cuspal covarage onlay

3D-printed

EXPERIMENTAL

3-D printed CAD/CAM composite restorations

Device: full cuspal covarage onlay

Interventions

full cuspal covarage onlay DEVICE

Composite onlays prepared with CAD/CAM technology

3D-printed; Milled

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Semmelweis University: lead

Study Sites (1)

Semmelweis University, Department of Restorative Dentistry and Endodontics

Budapest, Budapest, 1088, Hungary

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Model Details: split-mouth

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 9, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): April 18, 2036
• Study Completion (Estimated): December 10, 2036
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)