Health TrialsbyHealthPanel

Clinical Evaluation of Additive and Subtractive Onlay Restorations

ConditionsCAD-CAMProspective Study3D PrintingClinical Assessment
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-84
SponsorAyse Tugba Erturk Avunduk

About this trial

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.

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 3D Printed Onlay Restoration

    Device

    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 Restoration

    Device

    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.

Treatment groups

29 Participants
are divided into 2 treatment groups
Group A: Additive Manufacturing (3D Printing) Onlay RestorationsExperimental treatment 1 intervention
Group B: Subtractive Manufacturing (CAD/CAM Milling) Onlay RestorationsActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
Baseline (1 week), 6 months, 12 months, and 18 months after restoration placement

Secondary outcomes

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.

Time frame
Baseline (1 week), 6 months, 12 months, and 18 months

Other outcomes

1

Biological Properties of Onlay Restorations

Biological properties, including secondary caries, hard tissue defects at restoration margins, postoperative sensitivity, and pulpal status, will be evaluated clinically and radiographically according to 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.

Time frame
Baseline (1 week), 6 months, 12 months, and 18 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ayse Tugba Erturk Avunduk

Lead sponsor

Mersin University

Sponsor institution

Mersin University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: