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

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

Status

Enrolling by invitation

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07519382

Acronym

CUSTOM

Enrollment

164

Registered

2026-04-09

Start date

2026-04-10

Completion date

2036-12-10

Last updated

2026-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tooth Decay

Keywords

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

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.

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

DEVICEfull cuspal covarage onlay

Composite onlays prepared with CAD/CAM technology

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention model description

split-mouth

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
The rate of survival of the onlays at the specific time points	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.

Countries

Hungary

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 14, 2026