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CAD-CAMCIP-ONLAYNCT07195201

Clinical Evaluation of Additive and Subtractive Onlay Restorations

A study testing 3D Printed Onlay Restoration and CAD/CAM Onlay Restoration in people with CAD-CAM and Prospective Study, run by Ayse Tugba Erturk Avunduk at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to learn whether onlay restorations produced by additive manufacturing [three-dimensional (3D) printing] and subtractive manufacturing [Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM) milling] perform equally well in vital posterior teeth. Read more about this study

Who is it for?
Ages 18 to 84 years
Conditions the study is for
CAD-CAM, Prospective Study, 3D Printing
What is being tested?
3D Printed Onlay Restoration and CAD/CAM Onlay Restoration
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Nov 2025to 31 Aug 2027
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 to 84 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant-Level Criteria
  • Adults aged 18-84 years
  • No active periodontal disease (probing depth ≤ 3 mm, no clinical attachment loss)
  • No parafunctional habits such as bruxism, clenching, or foreign object chewing
  • Willingness to attend regular follow-up visits during the study period
  • Adequate oral hygiene status
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  • No history of systemic disease or medically stable condition if present
  • No history of similar restorative procedures involving the target teeth Tooth-Level Criteria
  • Vital posterior teeth (premolars or molars) confirmed by thermal or electric pulp testing; teeth requiring endodontic treatment or with necrosis will be excluded
  • Permanent posterior teeth located in functional occlusion (premolar or molar region)
  • Teeth with moderate structural loss suitable for onlay restorations, including mesio-occlusal (MO), disto-occlusal (DO), or mesio-occluso-distal (MOD) cavities with partial crown loss but sufficient remaining tooth structure not requiring full coverage
  • Periodontally healthy teeth with no mobility, no clinical attachment loss, and probing depth ≤ 3 mm
  • Teeth that can be matched in contralateral quadrants to allow split-mouth design (structurally and clinically comparable teeth)
  • Teeth free from cracks, fractures, or internal resorption; supporting tissues without structural defects that may compromise restoration success
  • Teeth with clearly defined preparation margins located in enamel or sound dentin; subgingival margins extending deep into the sulcus will not be included
  • Teeth without previous extensive prosthetic restorations (crowns, inlays/onlays, or implant-supported restorations)
  • Opposing natural teeth in stable occlusal contact with the restored tooth

Who cannot join

  • Teeth with pulp necrosis or a history of endodontic treatment (previous root canal therapy or non-vital teeth)
  • Teeth with excessive tissue loss requiring full crown coverage and unsuitable for onlay restoration
  • Teeth presenting with cracks, fractures, internal or external resorption, or structural defects compromising prognosis
  • Advanced periodontal disease, including clinical attachment loss, furcation involvement, mobility, or probing depth > 3 mm
  • Teeth with subgingival cavity margins extending deep into the gingival sulcus, increasing periodontal risk
  • Teeth with a history of fixed prosthetic restorations (previous crowns, inlays/onlays, or bridge restorations)
Show all 12Show fewer
  • Teeth lacking proximal contacts due to adjacent tooth absence, leading to compromised contact stability and occlusal load distribution
  • Teeth in regions with orthodontic appliances or fixed retainers that may interfere with restorative procedures or evaluation
  • Opposing teeth absent or lacking stable occlusal contact with the restoration site
  • Patients with systemic diseases contraindicate elective dental treatment (e.g., uncontrolled diabetes, immunocompromised status)
  • Pregnant or breastfeeding women
  • Patients unable or unwilling to attend scheduled follow-up visits [baseline (1 week), 6 months, 12 months, and 18 months]

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ayse Tugba Erturk-Avunduk, Associate Profesor contact

+90 541 446 62 61

aysetugba11@gmail.com

Turkey (Türkiye)1 site
  • Mersin University, Faculty of Dentistry, Department of Restorative Dentistry

    Mersin, Yenisehir, 33343

    Ayse Tugba Erturk-Avunduk, Associate Professor, +90 541 446 62 61, aysetugba11@gmail.com

    Kardelen KIRAN, Research Assistant

Other trials in Turkey (Türkiye)

About this study

Official title: Prospective Evaluation of Onlay Restorations Produced by Additive and Subtractive Manufacturing in Vital Posterior Teeth: A Split-Mouth

The goal of this clinical trial is to learn whether onlay restorations produced by additive manufacturing [three-dimensional (3D) printing] and subtractive manufacturing [Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM) milling] perform equally well in vital posterior teeth. The main questions it aims to answer are:

  • Do 3D printed onlay restorations show similar marginal adaptation and clinical performance compared to CAD/CAM milled onlays?
  • Are there any differences in biological compatibility, surface properties, or postoperative sensitivity between the two techniques over time? Researchers will compare onlay restorations fabricated with 3D printing and CAD/CAM milling using a split-mouth study design.
Read more

Participants will:

  • Receive one onlay restoration produced by 3D printing and another produced by CAD/CAM milling, placed on opposite sides of the mouth
  • Have checkups at baseline (1st week), 6 months, 12 months, and 18 months after treatment
  • Be evaluated using the Fédération Dentaire Internationale (FDI) criteria for marginal adaptation, surface quality, anatomical form, and biological compatibility
Read the detailed description

This prospective, randomized, split-mouth clinical trial is designed to evaluate the clinical performance of onlay restorations fabricated by two different digital manufacturing techniques-additive manufacturing (3D printing) and subtractive manufacturing (CAD/CAM milling)-in vital posterior teeth.

Each participant will receive two onlay restorations: one produced by CAD/CAM milling using hybrid ceramic blocks (GC Cerasmart 270) and one produced by 3D printing with a biocompatible permanent resin (Bego VarseoSmile TriniQ). The restorations will be placed in contralateral posterior teeth, allowing direct intra-individual comparison under identical oral conditions. Randomization will determine which tooth receives which manufacturing method.

The primary outcome of the study is marginal adaptation, assessed according to the Fédération Dentaire Internationale (FDI) World Dental Federation criteria. Secondary outcomes include surface quality, anatomical form, functional stability, postoperative sensitivity, color match, and biological compatibility. Clinical evaluations will be performed at baseline (1 week) and at 6 months, 12 months, and 18 months.

To minimize bias, participants and clinical evaluators will remain blinded to the type of restoration applied. Calibration sessions will be conducted for all evaluators to ensure consistency and reliability of outcome assessment. An independent statistician, blinded to group allocation, will perform the statistical analyses.

A total of 29 participants are expected to be enrolled, based on power analysis using G*Power software, which indicated that this sample size provides 85% power with a 95% confidence level. Inclusion criteria consist of adults aged 18-84 with vital posterior teeth requiring onlay restorations, without systemic disease or active periodontal pathology. Teeth with pulp vitality confirmed by thermal or electrical testing and with moderate structural loss suitable for onlay restorations will be included. Exclusion criteria include teeth with previous endodontic treatment, advanced periodontal disease, or a history of full-coverage prosthetic restoration.

All procedures will follow standardized clinical protocols, including tooth preparation, digital intraoral scanning, design with CAD software, manufacturing with either milling or 3D printing, and adhesive cementation. Adverse events such as restoration failure, pulp complications, or allergic reactions to materials will be documented and reported according to regulatory requirements.

This study is expected to provide robust, long-term clinical evidence comparing the performance of additively and subtractively manufactured onlay restorations, addressing a current gap in the literature. The results will contribute to evidence-based clinical decision-making in digital restorative dentistry and support the development of guidelines for material and technique selection.

Being tested
3D Printed Onlay Restoration, CAD/CAM Onlay Restoration
Keywords
onlay restorations, cad-cam, additive manufacturing, 3D printing, FDI criteria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3D Printed Onlay RestorationDevice

    Also called Additive Manufacturing; Bego VarseoSmile TriniQ

    Onlay restorations will be fabricated using a 3D printer and a biocompatible permanent resin (Bego VarseoSmile TriniQ). Digital intraoral scans will be used for design. Restorations will be placed in vital posterior teeth and evaluated at (1 week), 6 months, 12 months, and 18 months according to FDI criteria.

  • CAD/CAM Onlay RestorationDevice

    Onlay restorations will be fabricated using a CAD/CAM milling unit and hybrid ceramic blocks (GC Cerasmart 270). Digital intraoral scans will be used for design. Restorations will be placed in vital posterior teeth and evaluated at (1 week), 6 months, 12 months, and 18 months according to FDI criteria.

Study groups in NCT07195201
Study groupRoleWhat they receive
Additive Manufacturing (3D Printing) Onlay RestorationsExperimentalOnlay restorations will be fabricated using additive manufacturing technology (3D printing) with a biocompatible permanent resin (Bego VarseoSmile TriniQ). Restorations will be designed based on digital intraoral scans and placed in vital posterior teeth. Clinical evaluations will be performed at baseline (1 week), 6 months, 12 months, and 18 months according to FDI criteria.
Receives: Device: 3D Printed Onlay Restoration
Subtractive Manufacturing (CAD/CAM Milling) Onlay RestorationsActive comparatorOnlay restorations will be fabricated using subtractive manufacturing technology (CAD/CAM milling) with hybrid ceramic blocks (GC Cerasmart 270). Restorations will be designed based on digital intraoral scans and placed in vital posterior teeth. Clinical evaluations will be performed at (1 week), 6 months, 12 months, and 18 months according to FDI criteria.
Receives: Device: CAD/CAM Onlay Restoration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Functional Properties of Onlay Restorations

    Functional performance of onlay restorations, including marginal adaptation, fracture and retention of the material, proximal contact point, anatomical form, occlusion, and wear, will be assessed using the Fédération Dentaire Internationale (FDI) criteria. Restorations will be scored as clinically excellent, clinically good, clinically sufficient/satisfactory, or clinically poor/unacceptable. The proportion of restorations receiving clinically acceptable scores (scores 1-3) will be recorded.

    Measured: Baseline (1 week), 6 months, 12 months, and 18 months after restoration placement

Secondary outcomes (1)
  1. Esthetic Properties of Onlay Restorations

    Esthetic properties, including surface gloss and texture, marginal discoloration, and color match, will be assessed using FDI criteria. Restorations will be scored as clinically excellent, clinically good, clinically sufficient/satisfactory, or clinically poor/unacceptable. The proportion of restorations receiving clinically acceptable scores (scores 1-3) will be recorded.

    Measured: Baseline (1 week), 6 months, 12 months, and 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2025
  2. Study start15 Nov 2025 (estimated)
  3. Primary completion31 May 2027 (estimated)
  4. Study completion31 Aug 2027 (estimated)

Resources

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
"randomized, controlled, double-blind, split-mouth design"
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
29 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07195201
Sponsor's protocol ID
CIP-ONLAY-2025-V01
Other IDs
2025-157
Acronym
CIP-ONLAY
Status last verified
Sep 2025
First submitted
10 Sep 2025
Last updated
26 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: Individual participant data will not be shared. Only aggregated, anonymized study results will be disseminated through scientific publications and conference presentations.

Publications

  • Revilla-Leon M, Alonso Perez-Barquero J, Barmak AB, Agustin-Panadero R, Fernandez-Estevan L, Gomez-Polo M. Accuracy of Intraoral Scanner Systems for Fabricating Inlay, Onlay, and Veneer Restorations: A Systematic Review and Meta-Analysis. J Esthet Restor Dent. 2025 Mar;37(3):727-755. doi: 10.1111/jerd.13361. Epub 2024 Dec 11.

    PubMed 39663747
  • 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.

    PubMed 36504246
  • Coskun E, Aslan YU, Ozkan YK. Evaluation of two different CAD-CAM inlay-onlays in a split-mouth study: 2-year clinical follow-up. J Esthet Restor Dent. 2020 Mar;32(2):244-250. doi: 10.1111/jerd.12541. Epub 2019 Oct 23.

    PubMed 31642587

Questions about this trial

What is this clinical trial studying?

A study testing 3D Printed Onlay Restoration and CAD/CAM Onlay Restoration in people with CAD-CAM and Prospective Study, run by Ayse Tugba Erturk Avunduk at 1 site in Turkey (Türkiye).

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 17 inclusion and 12 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: opening soon, as of the sponsor's last update on 26 Sep 2025. 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 Turkey (Türkiye). 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?

Contact Ayse Tugba Erturk-Avunduk, Associate Profesor (+90 541 446 62 61, aysetugba11@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional Properties of Onlay Restorations (time frame: Baseline (1 week), 6 months, 12 months, and 18 months after restoration placement). 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 NCT07195201, 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 26 Sep 2025.

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