Tooth DecayCUSTOMNCT07519382
Comparing the Clinical Success of Two Different CAD/CAM Full Cuspal Coverage Onlays
A study testing full cuspal covarage onlay in people with Tooth Decay, run by Semmelweis University at 1 site in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tooth Decay
- What is being tested?
- full cuspal covarage onlay
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteHungary
- Study dates
- 10 Apr 2026to 10 Dec 2036
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hungary1 site
Semmelweis University, Department of Restorative Dentistry and Endodontics
Budapest, Budapest, 1088
About this study
Official title: 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.
Read the 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.
- Conditions
- Tooth Decay
- Being tested
- full cuspal covarage onlay
- Keywords
- milling, 3-D printing, full-cuspal coverage onlay
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
full cuspal covarage onlayDevice
Composite onlays prepared with CAD/CAM technology
| Study group | Role | What they receive |
|---|---|---|
| Milled | Active comparator | Milled CAD/CAM composite restorations Receives: Device: full cuspal covarage onlay |
| 3D-printed | Experimental | 3-D printed CAD/CAM composite restorations Receives: Device: full cuspal covarage onlay |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Survival will be evaluated at specific follow-up time points (1 week, 6 months, 1 year - 10 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start10 Apr 2026 (estimated)
- Primary completion18 Apr 2036 (estimated)
- Study completion10 Dec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tooth DecayStudies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- split-mouth
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eszter Á Szalai, DMD, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07519382
- Sponsor's protocol ID
- BM/24614-1/2025
- Acronym
- CUSTOM
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 37067049Hickel 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.
PubMed 36504246Alzraikat 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.
PubMed 29570020
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Clinical Success of Milled and 3-D Printed Composite CAD/CAM Full Cuspal Coverage Onlays
- ClinicalTrials.gov ID
- NCT07519382
- Acronym / sponsor ID
- CUSTOM / BM/24614-1/2025
- Conditions
- Tooth Decay
- Keywords
- milling, 3-D printing, full-cuspal coverage onlay
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 10 Apr 2026 (estimated)
- Primary completion
- 18 Apr 2036 (estimated)
- Study completion
- 10 Dec 2036 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- split-mouth
| Arm | Type | Receives |
|---|---|---|
| Milled | Active comparator | Device: full cuspal covarage onlayMilled CAD/CAM composite restorations |
| 3D-printed | Experimental | Device: full cuspal covarage onlay3-D printed CAD/CAM composite restorations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Inadequate oral hygiene
- Pregnancy
- Allergies to restorative materials
- Parafunctional habits (e.g., teeth grinding or clenching)
- Presence of orthodontic appliances
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| full cuspal covarage onlayComposite onlays prepared with CAD/CAM technology | Device | 3D-printed, Milled |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Background: PubMed 37067049Sahin 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.
- Background: PubMed 36504246Hickel 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.
- Background: PubMed 29570020Alzraikat 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing full cuspal covarage onlay in people with Tooth Decay, run by Semmelweis University at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07519382, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.