Clinical Evaluation of Additive and Subtractive Onlay Restorations

NCT07195201 | Not Yet Recruiting FDA Device

• 2 other identifiers: CIP-ONLAY-2025-V012025-157
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

CAD-CAM; Prospective Study; 3D Printing; Clinical Assessment

Keywords

onlay restorations; cad-cam; additive manufacturing; 3D printing; FDI criteria

Outcome Measures

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.

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

Secondary Outcomes (1)

• Esthetic Properties of Onlay Restorations

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

Other Outcomes (1)

• Biological Properties of Onlay Restorations

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

Study Arms (2)

Additive Manufacturing (3D Printing) Onlay Restorations

EXPERIMENTAL

Onlay 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.

Device: 3D Printed Onlay Restoration

Subtractive Manufacturing (CAD/CAM Milling) Onlay Restorations

ACTIVE COMPARATOR

Onlay 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.

Device: CAD/CAM Onlay Restoration

Interventions

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.

Also known as: Additive Manufacturing; Bego VarseoSmile TriniQ

Additive Manufacturing (3D Printing) Onlay Restorations

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.

Subtractive Manufacturing (CAD/CAM Milling) Onlay Restorations

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)
• 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 \[baseline (1 week), 6 months, 12 months, and 18 months\]

Sponsors & Collaborators

• Ayse Tugba Erturk Avunduk: lead
• Mersin University: collaborator

Study Sites (1)

Mersin University, Faculty of Dentistry, Department of Restorative Dentistry

Mersin, Yenisehir, 33343, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 39663747 BACKGROUND

• Weick A. Issues in overturning a medical model of social work practice. Soc Work. 1983 Nov-Dec;28(6):467-71. doi: 10.1093/sw/28.6.467. No abstract available.

  PMID: 10264483 BACKGROUND

• 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.

  PMID: 31642587 BACKGROUND

Related Links

• Related Info
• Related Info

Central Study Contacts

Ayse Tugba Erturk-Avunduk, Associate Profesor

CONTACT

+90 541 446 62 61; aysetugba11@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind clinical trial. Participants and outcome assessors are blinded to the allocation of onlay restorations fabricated by additive or subtractive manufacturing. The care provider performing the intervention cannot be blinded due to the nature of the manufacturing process.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: "randomized, controlled, double-blind, split-mouth design"

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 26, 2025
• Study Start: November 15, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)