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- Essai clinique NCT07648485
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities: Two-Year Randomized Clinical Trial
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
A wide variety of materials is now available for the fabrication of indirect restorations used to manage extensive carious lesions, including high-strength ceramics, hybrid ceramics, and resin-composite blocks. Each material offers distinct advantages in strength, wear resistance, aesthetics, and bonding performance, thereby expanding treatment options for severely compromised posterior teeth. However, these differences in mechanical and optical behavior, marginal adaptation, and long-term durability under functional stresses complicate clinical material selection.
Limited data is available comparing the clinical performance of these materials, particularly in large cavities in these regions. More information is needed on how they prevent post-treatment sensitivity, maintain edge quality, and resist discoloration, wear, and fractures.
Though short-term studies indicate excellent survival rates and aesthetic results for CAD/CAM hybrid ceramic inlays (more than 90% survival after two years), and systematic reviews imply that CAD/CAM resin composite inlays match ceramic restorations (success rates ranging from 85.7% to 100% for composites versus 93.3% to 100% for ceramics). There is a lack of direct clinical comparisons between these two material types in vital molars with occluso-proximal cavities. Much of the existing research is constrained to onlay designs or mixed-material groups, creating a significant gap in understanding which CAD/CAM block type delivers superior long-term performance for inlay restorations in vital teeth.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
Accepte les volontaires sains
La description
Inclusion Criteria:
- Systematically healthy male or female subjects aged 16 to 50 years.
- Patients with good oral hygiene.
- Presence of a single vital molar with coronal destruction due to caries, defined as radiographic evidence of caries involving more than 50% of the total dentin thickness with loss of at least one proximal wall.
- Cavitary preparation involving loss of at least one proximal walls (mesial and/or distal), with intact buccal and lingual walls, and all cavosurface margins located in enamel.
- Presence of functional opposing teeth in stable occlusion
Exclusion Criteria:
- Presence of systemic diseases (e.g., uncontrolled diabetes, immune disorders).
- Current pregnancy or lactation.
- Documented allergy to resin-based composites or adhesive systems.
- Evidence of pulpal necrosis or previous endodontic treatment in the target tooth.
- Presence of cracks or fractures involving the tooth structure.
- Active localized or generalized periodontal disease.
- Evidence of parafunctional habits, including bruxism or clenching.
- High caries risk.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Hybrid ceramic group
indirect restoration (inlay design) using CAD/CAM Fabricated Hard Hybrid Ceramic blocks
|
after caries removal, inlay cavity preparation and immediate dentin sealing, the cavities were scanned using intraoral scanner and the restoration designed and milled using Hard Hybrid Ceramic Blocks.
the intaglio surface was air-abraded with 50 μm Al2O3 for 10-15 seconds.
SHOFU HC Primer will be applied to the hybrid-ceramic group.
|
|
Comparateur actif: Composite Resin group
indirect restoration (inlay design) using CAD/CAM Fabricated from Composite Resin Blocks
|
after caries removal, inlay cavity preparation and immediate dentin sealing, the cavities were scanned using intraoral scanner and the restoration designed and milled using Composite Resin Blocks.
the intaglio surface was air-abraded with 50 μm Al2O3 for 10-15 seconds.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Marginal Adaptation
Délai: -baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
|
measured using modified United States Public Health Service (USPHS) criteria scored as Alpha, Bravo, Charlie, Delta (Alpha score is the best and Delta is the worst).
|
-baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
color match
Délai: -baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
|
measured using modified United States Public Health Service (USPHS) criteria scored as Alpha, Bravo, Charlie, Delta (Alpha score is the best and Delta is the worst).
|
-baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
|
|
marginal discoloration
Délai: -baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
|
measured using modified United States Public Health Service (USPHS) criteria scored as Alpha, Bravo, Charlie, Delta (Alpha score is the best and Delta is the worst).
|
-baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
|
|
aesthetic anatomic form
Délai: -baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
|
measured using modified United States Public Health Service (USPHS) criteria scored as Alpha, Bravo, Charlie, Delta (Alpha score is the best and Delta is the worst).
|
-baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
|
|
recurrent caries
Délai: -baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
|
measured using modified United States Public Health Service (USPHS) criteria scored as Alpha, Bravo, Charlie, Delta (Alpha score is the best and Delta is the worst).
|
-baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
|
|
restoration fracture
Délai: -baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
|
measured using modified United States Public Health Service (USPHS) criteria scored as Alpha, Bravo, Charlie, Delta (Alpha score is the best and Delta is the worst).
|
-baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
|
|
Post-operative hypersensitivity
Délai: -baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
|
measured using modified United States Public Health Service (USPHS) criteria scored as Alpha, Bravo, Charlie, Delta (Alpha score is the best and Delta is the worst).
|
-baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- Coskun E, Aslan YU, Ozkan YK. Evaluation of two different CAD-CAM inlay-onlays in a split-mouth study: 2-year clinical follow-up. J Esthet Restor Dent. 2020 Mar;32(2):244-250. doi: 10.1111/jerd.12541. Epub 2019 Oct 23.
- Tennert C, Maliakal C, Suarez Machado L, Jaeggi T, Meyer-Lueckel H, Wierichs Richard J. Longevity of posterior direct versus indirect composite restorations: A systematic review and meta-analysis. Dent Mater. 2024 Nov;40(11):e95-e101. doi: 10.1016/j.dental.2024.07.033. Epub 2024 Aug 9.
- Hassan A, Hamdi K, Ali AI, Al-Zordk W, Mahmoud SH. Clinical performance comparison between lithium disilicate and hybrid resin nano-ceramic CAD/CAM onlay restorations: a two-year randomized clinical split-mouth study. Odontology. 2024 Apr;112(2):601-615. doi: 10.1007/s10266-023-00841-w. Epub 2023 Aug 5.
- Fathy H, Hamama HH, El-Wassefy N, Mahmoud SH. Clinical performance of resin-matrix ceramic partial coverage restorations: a systematic review. Clin Oral Investig. 2022 May;26(5):3807-3822. doi: 10.1007/s00784-022-04449-2. Epub 2022 Mar 23.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CairoU-Hybrid Ceramic Inlays
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
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