Clinical Evaluation of 3D-Printed Versus Semi-Direct Composite Resin Restorations

NCT07676929 | Active Not Recruiting DMC

• 1 other identifier: 3D-Printed Composite
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled clinical trial aims to evaluate the clinical performance of 3D-printed composite resin restorations compared with semi-direct composite resin restorations in posterior teeth requiring Class II inlay or onlay restorations.

Conditions

Composite Restoration; 3D Printing; Posterior Teeth; Semi-direct Restoration

Keywords

3D-Printed Composite Resin; Semi-Direct Composite Resin; Digital Dentistry; FDI Criteria; Clinical Evaluation

Outcome Measures

Primary Outcomes (1)

• Fracture of restorations

  Clinical evaluation of restoration fracture or bulk failure after placement of 3D-printed composite resin and semi-direct composite resin restorations. at baseline, 6 months, 9 months, and 12 months after restoration placement. using a modified FDI criteria score. All restorations will be evaluated and categorized based on their clinical performance according to the assigned criteria: score 1 indicates a clinically excellent restoration, scores 2 and 3 represent clinically acceptable restorations, while scores 4 and 5 are considered clinically unacceptable. Clinical success will be defined as restorations receiving scores of 1, 2, or 3, whereas scores of 4 or 5 will be considered clinical failures.

  12 months

Study Arms (2)

3D-Printed Composite Resin Restorations

EXPERIMENTAL

Participants will receive Class II inlay or onlay restorations fabricated using 3D-printed composite resin. Restorations will be placed following standardized cavity preparation and manufacturer instructions. Clinical performance will be evaluated at baseline, 6, 9, and 12 months using modified FDI criteria

Other: 3D-Printed Composite Resin Restorations

Semi-Direct Composite Resin Restorations

EXPERIMENTAL

Participants will receive Class II inlay or onlay restorations fabricated using the semi-direct composite resin technique. Restorations will be placed following standardized cavity preparation and manufacturer instructions. Clinical performance will be evaluated at baseline, 6, 9, and 12 months using modified FDI criteria

Other: Semi-Direct Composite Resin Restorations

Interventions

3D-Printed Composite Resin Restorations OTHER

Fabrication and placement of Class II inlay or onlay restorations using 3D-printed composite resin material.

3D-Printed Composite Resin Restorations

Semi-Direct Composite Resin Restorations OTHER

Fabrication and placement of Class II inlay or onlay restorations using the semi-direct composite resin technique

Semi-Direct Composite Resin Restorations

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged 25-40 years.
• Patients requiring two Class II inlay or onlay restorations.
• Teeth with carious lesions or defective restorations requiring indirect restorative treatment.
• Teeth with sufficient structure to receive an inlay/onlay restoration.

You may not qualify if:

• Patients with systemic diseases or medical conditions that may affect oral health or healing.
• Pregnant or lactating patients.
• Patients with poor oral hygiene or uncontrolled periodontal disease.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Restorative Department, Faculty of Dentistry, Tanta University

Tanta, Tanta, 31527, Egypt

Location

Related Publications (4)

• Nguyen-Thi TL, Tran TM, Tran-Thi HP, Nguyen-Ho PM, Do TT, Dang MH. Effect of preparation design on the fracture behavior of 3D-printed restorations in an in-vitro tooth wear model. BMC Oral Health. 2026 Mar 12;26(1):704. doi: 10.1186/s12903-026-08031-0.

  PMID: 41820942 RESULT

• Tribst JPM, Veerman A, Pereira GKR, Kleverlaan CJ, Dal Piva AMO. Comparative Strength Study of Indirect Permanent Restorations: 3D-Printed, Milled, and Conventional Dental Composites. Clin Pract. 2024 Sep 20;14(5):1940-1952. doi: 10.3390/clinpract14050154.

  PMID: 39311304 RESULT

• Kaffaf MB, Sesen P, Tokac SO. Comparison of the intaglio surface accuracy of occlusal veneers fabricated using two different techniques to restore severe occlusal tooth wear: An in vitro study. J Prosthet Dent. 2026 Jun;135(6):e97-e105. doi: 10.1016/j.prosdent.2025.12.027. Epub 2026 Jan 6.

  PMID: 41500877 RESULT

• Peskersoy C, Acar G. In Vitro Evaluation of the Mechanical Properties of Posterior Adhesive Restorations Fabricated Using Three Different Techniques. Polymers (Basel). 2025 May 14;17(10):1340. doi: 10.3390/polym17101340.

  PMID: 40430636 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: June 30, 2026
• Study Start: January 5, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): March 3, 2027
• Last Updated: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)