- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07756333
Evaluation of Composite Veneers Fabricated by 3D Printing and Milling Technologies
10 août 2026 mis à jour par: youssef alaa
Evaluation of Composite Veneers Fabricated by 3D Printing and Milling Technologies (Randomized Controlled Clinical Trial & In-Vitro Study)
The clinical study aimed to evaluate the clinical performance, color stability, and wear of indirect composite veneers produced using 3D printing and milling technologies.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
A total of fifty-six anterior indirect veneers will be fabricated using 3D printing and milling technologies.
The veneers will be divided into two groups according to the technique of fabrication.
Group I: 28 veneers will be done using 3D printing technology (VarseoSmile TriniQ, Bego), and group II: 28 veneers will be done using milling technology (Cerasmart 270, GC).
Veneer restorations will be fabricated checked, and cemented, then will be evaluated using the modified FDI criteria at baseline, three months, six months, and one year.
Moreover, color stability and surface wear of the restorations will be evaluated in each follow-up session.
Type d'étude
Interventionnel
Inscription (Réel)
14
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
-
Alexandria, Egypte
- Faculty of dentistry, Alexandria university
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Non
La description
Inclusion Criteria:
- Healthy adult patients aged 18 to 45 years.
- Patients requiring veneer restorations due to discoloration, misalignment, tooth malformation or having irregular tooth shape that can be treated without full coverage.
- Patients meeting the criteria for Class I or Class II veneers according to the LeSage veneer classification system.
- Patients requiring veneers restorations on their bilateral maxillary anterior teeth.
- The selected teeth should be vital with absence of clinical signs and symptoms of periapical pathology.
- Patients having a normal occlusal relationship between upper and lower teeth (class I Angle classification).
- Patients capable of tolerating rubber dam applications.
- Patients willing to attend regular follow-up appointments.
Exclusion Criteria:
- Bad oral hygiene (Oral Hygiene Index Simplified >3).
- Non-vital teeth or endodontically treated teeth.
- Severe periodontal disease.
- Patients with para-functional habits (e.g., bruxism, attrition, wear facets).
- Dentin exposure more than 20% of the prepared surface for veneer.
- Prescence of smoking/vaping habits
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
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 |
|---|---|
|
Comparateur actif: Group I: 28 veneers will be done using 3D printing technology (VarseoSmile TriniQ, Bego)
|
A total of fifty-six anterior indirect veneers will be fabricated using 3D printing and milling technologies.
The veneers will be divided into two groups according to the technique of fabrication.
Group I: 28 veneers will be done using 3D printing technology (VarseoSmile TriniQ, Bego), and group II: 28 veneers will be done using milling technology (Cerasmart 270, GC).
Veneer restorations will be fabricated checked, and cemented, then will be evaluated using the modified FDI criteria at baseline, three months, six months, and one year.
Moreover, color stability and surface wear of the restorations will be evaluated in each follow-up session.
|
|
Comparateur actif: group II: 28 veneers will be done using milling technology (Cerasmart 270, GC)
|
A total of fifty-six anterior indirect veneers will be fabricated using 3D printing and milling technologies.
The veneers will be divided into two groups according to the technique of fabrication.
Group I: 28 veneers will be done using 3D printing technology (VarseoSmile TriniQ, Bego), and group II: 28 veneers will be done using milling technology (Cerasmart 270, GC).
Veneer restorations will be fabricated checked, and cemented, then will be evaluated using the modified FDI criteria at baseline, three months, six months, and one year.
Moreover, color stability and surface wear of the restorations will be evaluated in each follow-up session.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The functional properties of the examined veneer restorations
Délai: 1 year
|
All veneers were assessed clinically at 1 week (baseline) and subsequently at 3, 6, and 12 months, following the FDI evaluation criteria and scoring system, which indicates: Functional properties: (F1) Fracture of material and retention.
(F2) Marginal adaptation.
(F3) Proximal contact point.
(F4) Form and contour.
(F5) Occlusion and wear.
Each evaluated property was scored according to the FDI criteria using the following clinical scores: Score 1: Clinically excellent/very good (VG), Score 2: Clinically good (CG), score 3: Clinically satisfactory (CS), score 4: Clinically unsatisfactory (CU), score 5: Clinically poor (PO).
|
1 year
|
|
The biological properties of the examined veneer restorations
Délai: 1 year
|
All Veneers were assessed clinically at 1 week (baseline) and subsequently at 3, 6, and 12 months, following the revised FDI evaluation criteria and scoring system, which indicates: Biological properties (B1) Caries at restoration margins.
(B2) Dental hard tissue defects at the restoration margin.
(B3) Postoperative hypersensitivity and pulpal status.
Each evaluated property was scored according to the FDI criteria using the following clinical scores: Score 1: Clinically excellent/very good (VG), Score 2: Clinically good (CG), Score 3: Clinically satisfactory (CS), Score 4: Clinically unsatisfactory (CU), Score 5: Clinically poor (PO).
|
1 year
|
|
The aesthetic properties of the examined veneers
Délai: 1 year
|
All veneers were assessed clinically at 1 week (baseline) and subsequently at 3, 6, and 12 months, following the FDI evaluation criteria and scoring system, which indicates: Aesthetic properties: (A1) Surface luster and surface texture.
(A2) Marginal staining.
(A3) Color match.
Each evaluated property was scored according to the FDI criteria using the following clinical scores: Score 1: Clinically excellent/very good (VG), Score 2: Clinically good (CG), Score 3: Clinically satisfactory (CS), Score 4: Clinically unsatisfactory (CU), Score 5: Clinically poor (PO).
|
1 year
|
|
The color stability of the examined veneers
Délai: 1 year
|
All Veneers were assessed clinically at 1 week (baseline) and subsequently at 3, 6, 9, and 12 months using the vita easy shade spectrophotometer.
The CIEDE2000 formula will be used to measure the color change.
|
1 year
|
|
Wear resistance of the examined veneers
Délai: 1 year
|
All Veneers were scanned clinically using an intra oral scanner at 1 week (baseline) and subsequently at 3, 6, and 12 months.
The different scans were compared to baseline scan to assess the volume loss and accordingly the wear resistant.
|
1 year
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 mai 2025
Achèvement primaire (Réel)
5 août 2026
Achèvement de l'étude (Réel)
5 août 2026
Dates d'inscription aux études
Première soumission
5 août 2026
Première soumission répondant aux critères de contrôle qualité
5 août 2026
Première publication (Réel)
10 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
12 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
10 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 9262109
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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 .