Clinical Evaluation of 3D-Printed Versus Semi-Direct Composite Resin Restorations
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
Dental restorations are commonly used to restore teeth affected by caries or structural defects. Advances in digital dentistry have introduced three-dimensional (3D) printing technologies that enable the fabrication of indirect composite resin restorations with improved precision, efficiency, and reproducibility. Semi-direct composite resin restorations represent another conservative restorative approach that combines the advantages of direct and indirect techniques while reducing polymerization shrinkage and improving anatomical form.
Although both techniques are increasingly used in clinical practice, evidence regarding their long-term clinical performance remains limited. Therefore, this randomized controlled clinical trial aims to compare the clinical performance of 3D-printed composite resin restorations and semi-direct composite resin restorations in posterior teeth requiring Class II inlay or onlay restorations.
Sixty patients aged 25 to 40 years who require two Class II inlay or onlay restorations will be enrolled by invitation from patients attending the Faculty of Dentistry, Tanta University. Participants will be randomly allocated into two groups according to the restorative material and fabrication technique used. Group I will receive 3D-printed composite resin restorations, while Group II will receive semi-direct composite resin restorations.
All cavity preparations and restorative procedures will be performed according to standardized clinical protocols and manufacturers' instructions. Clinical evaluations will be conducted at baseline, 6 months, 9 months, and 12 months after restoration placement using the modified FDI World Dental Federation criteria.
The primary objective is to evaluate the overall clinical performance and survival of the restorations over a 12-month follow-up period. Secondary outcomes include assessment of retention, marginal integrity, surface roughness, anatomical form, postoperative sensitivity, and the occurrence of secondary caries.
The findings of this study will contribute to the evidence regarding the effectiveness and clinical reliability of 3D-printed composite resin restorations compared with semi-direct composite resin restorations and may support clinical decision-making in restorative dentistry.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Tanta
-
Tanta, Tanta, Egypte, 31527
- Restorative Department, Faculty of Dentistry, Tanta University
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 3D-Printed Composite Resin Restorations
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
|
Fabrication and placement of Class II inlay or onlay restorations using 3D-printed composite resin material.
|
|
Expérimental: Semi-Direct Composite Resin Restorations
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
|
Fabrication and placement of Class II inlay or onlay restorations using the semi-direct composite resin technique
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Fracture of restorations
Délai: 12 months
|
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
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- 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.
- 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.
- 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.
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 3D-Printed Composite
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .