Indirect Resin Composite Inlays Cemented With a Self-adhesive, Self-etch or a Conventional Resin Cement
Indirect Resin Composite Inlays Cemented With Three Different Luting Strategies
The present study was designed to provide further evidence in this particular research prospective, and this study hence aimed to clinically evaluate the 5-years adhesion durability of indirect resin composite inlays luted with three different resin cement strategies in MOD Class II restorations. The formulated null hypothesis was that there is no significant difference in the clinical performances of the three different resin cement strategies for luting indirect resin composite inlays in MOD Class II restorations for 5-years.
The research question was as follows: Do self-adhesive resin cements in class II restorations present better clinical performances than conventional etch-and-rinse and self-etch resin cements according to the USPHS criteria?
Aperçu de l'étude
Description détaillée
Objective: To clinically evaluate the 5 years adhesion durability of indirect resin composite inlays luted with three different resin cement strategies in MOD Class II restorations.
Materials and Methods: A randomized clinical trial was conducted following the protocol, 40 patients with three large cavities for each one that indicated for indirect MOD Class II restorations were enrolled in the current study. Then, 120 indirect resin composite inlay restorations (SR Nexco) were placed and luted with three different resin cement strategies; an etch-and-rinse (Variolink N), self-etch (Panavia F2.0) and self-adhesive (RelyX Unicem). Each resin cement was used for luting 20 inlay restorations. A single operator placed all restorations according to the manufacturer's instructions. Immediatelly after placement, the restorations were finished and polished. Clinical evaluation was performed at baseline and at 1, 3 and 5 years intervals after placement by two independent examiners using modified USPHS criteria. The changes in the USPHS parameters during the 5 years period were analyzed with Fredman test. The baseline scores were compared with those at the recall visits using Wilcoxon signed rank test, where the level of significance was set at p˂0.05.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Dakahlia
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Mansoura, Dakahlia, Egypte, 35516
- Faculty of dentistry
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Patients with primary caries involving occlusal surface only with ICDAS 2 and 3.
- Patients with cavities no more than one-third of the intercuspal distance.
- Patients must have a good oral hygiene.
- Patients with tooth gives positive response to testing with an electric pulp tester.
- Patients with normal and full occlusion.
- Patients with opposing teeth should be natural with no restorations.
Exclusion Criteria:
- High caries risk patients with extremely poor oral hygiene.
- Patients involved in orthodontic treatment or periodontal surgery.
- Patients with periodontally involved teeth (chronic periodontitis).
- Patients with abutments should be excluded.
- Patients with heavy bruxism habits and clenching.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: Etch-and-rinse (Variolink N) resin cement
For etch-and-rinse resin cement, 40 inlays were cemented by Variolink N resin cement.
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Etching enamel surface using phosphoric acid
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Comparateur placebo: Self-etch (Panavia F2.0) resin cement
Regarding self-etch resin cement, 40 inlays were cemented by Panavia F2.0 resin cement.
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Etching enamel surface using phosphoric acid
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Aucune intervention: Self-adhesive (RelyX Unicem) resin cement
For self-adhesive resin cement, 40 inlays were cemented by RelyX Unicem resin cement.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Percentage % of patients with marginal staining
Délai: 5 years after restoration procedure
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Percentage of marginal staining in patients was clinically assessed using USPHS criteria.
Restorations were given the score Alpha for the ideal clinical situation, Bravo for clinically acceptable and Charlie for clinically unacceptable and in need for replacement.
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5 years after restoration procedure
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
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
- A10150421
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Délai de partage IPD
Critères d'accès au partage IPD
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
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
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