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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Egypt
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Tanta, Egypt, Egitto, 31511
- aculty of Dentistry, Tanta University, Tanta, Tanta 31527
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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 |
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Comparatore attivo: 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 |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Fracture and retention
Lasso di tempo: 18 months
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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
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Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
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Inizio studio (Effettivo)
Completamento primario (Stimato)
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Date di iscrizione allo studio
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Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 3D-Printed & Direct Composite
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