Clinical Evaluation of 3D-Printed Versus Direct Composite Restorations in Class II Cavities
The aim of this study is to clinically evaluate the performance of 3D-printed composites compared to direct conventional composite restorations in Class II cavities
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Resin-based composites are widely used for posterior restorations because of their esthetics, adhesion, and conservative preparation. However, Class II restorations remain challenging due to polymerization shrinkage, marginal gaps, postoperative sensitivity, and inadequate proximal contacts. Digital additive manufacturing has emerged as a promising approach, offering precise fabrication, reduced material waste, and customizable restorations. Although laboratory studies suggest favorable mechanical properties and marginal adaptation, clinical evidence for 3D-printed intracoronal restorations remains limited. Therefore, this randomized clinical trial will compare the clinical performance of 3D-printed composite inlays with conventional direct composite restorations in Class II cavities over 24 months.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Egypt
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Tanta, Egypt, Egypt, 31511
- aculty of Dentistry, Tanta University, Tanta, Tanta 31527
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Have at least two Class II carious lesions corresponded to ICDAS scores 4 and 5, representing dentinal caries suitable for operative restorative treatment.
- The absence of ongoing orthodontic treatment or use of prostheses.
- Good general health without relevant disease.
Exclusion Criteria:
- Uncooperative patient.
- Any parafunctional habits such as tooth clenching or grinding.
- Chronic pulmonary diseases and blocked nasal passages.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 3D-Printed Composite Inlays
Participants will receive Class II restorations fabricated from a commercially available 3D-printable permanent composite resin using a standardized digital workflow. The restorations will be adhesively bonded to the prepared cavities according to the manufacturer's instructions. |
Class II cavities will be restored with digitally designed and 3D-printed permanent composite inlays. The restorations will be post-cured and adhesively cemented according to the material manufacturer's recommendations |
|
Active Comparator: Direct Composite Restorations
Participants will receive conventional direct Class II restorations using a commercially available resin-based composite. Restorations will be placed incrementally using a standardized adhesive protocol and light-curing procedure according to the manufacturer's recommendations. Both groups will be clinically evaluated at baseline and during the 18-month follow-up period using standardized clinical criteria. |
Class II cavities will be restored directly using a conventional light-cured resin-based composite placed with a standardized incremental technique and adhesive protocol |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fracture and retention
Time Frame: 18 months
|
Description: Clinical evaluation of fracture and retentin was conducted in accordance with the World Dental Federation (FDI) criteria by two calibrated examiners at baseline and after 6, 12, and 18 months. Each restoration was evaluated according to the degree of conformity with the established criteria as follows: score 1, excellent; scores 2 and 3, satisfactory; and scores 4 and 5, inadequate. Scores of 1-3 were considered indicative of clinical success, whereas scores of 4 or 5 were considered indicative of failure. |
18 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Balestra D, Lowther M, Goracci C, Mandurino M, Cortili S, Paolone G, Louca C, Vichi A. 3D Printed Materials for Permanent Restorations in Indirect Restorative and Prosthetic Dentistry: A Critical Review of the Literature. Materials (Basel). 2024 Mar 18;17(6):1380. doi: 10.3390/ma17061380.
- Duarte S Jr, Phark JH. Advances in Dental Restorations: A Comprehensive Review of Machinable and 3D-Printed Ceramic-Reinforced Composites. J Esthet Restor Dent. 2025 Jan;37(1):257-276. doi: 10.1111/jerd.13371. Epub 2024 Nov 18.
- Tanaka LEB, da Silva Rodrigues C, Grangeiro MTV, Campos TMB, de Melo RM. Characterization of 3D printed composite for final dental restorations. Clin Oral Investig. 2024 Oct 31;28(11):617. doi: 10.1007/s00784-024-06003-8.
- Peskersoy C, Oguzhan A. Evaluation of the Mechanical and Adhesion Characteristics of Indirect Restorations Manufactured with Three-Dimensional Printing. Polymers (Basel). 2024 Feb 23;16(5):613. doi: 10.3390/polym16050613.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 3D-Printed & Direct Composite
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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