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臨床試験

PICN Versus Bioactive Composite for Cervical Restorations in Ballet Dancers

NCT: NCT07598305 · COMPLETED

NCT識別子NCT07598305
ステータスCOMPLETED
開始日2021-12-09
完了2024-12-09
SponsorI.M. Sechenov First Moscow State Medical University (OTHER)
First posted
Last updated

概要

Background and Objectives: Professional ballet dancers endure high occlusal loads, increasing cervical defect prevalence. Conventional composites fail frequently under such conditions. This randomized clinical trial (RCT) compared 24 month performance of a polymer infiltrated ceramic network (PICN, VITA Enamic) versus a self curing bioactive composite (Stela) for cervical restorations. Materials and Methods: Twenty professional ballet dancers (40 cervical defects: 21 carious, 19 abfraction) were enrolled in a split mouth RCT. Each received one PICN inlay and one self curing composite restoration on two non adjacent defects. Restorations were assessed at 6, 12, and 24 months using United States Public Health Service (USPHS) criteria (primary: marginal integrity) and a dye penetration test. Secondary outcomes included secondary caries, hypersensitivity, and Oral Health Impact Profile-14 (OHIP 14). Statistical tests: McNemar, Fisher's exact, Kaplan-Meier, log rank (α=0.05). Results: At 24 months, no PICN restoration failed (0%). Self curing composite failures were 20% (carious) and 30% (abfraction) (exploratory uncorrected p=0.031; non significant after correction). Dye penetration was lower for PICN in abfraction defects (11% vs. 60%, adjusted p=0.048) but not in carious defects (9% vs. 30%, adjusted p=0.317). Kaplan-Meier survival favoured PICN (log rank p=0.001); 24 month survival probability: PICN 100% (95% CI: 83-100%), self curing composite 75% (95% CI: 55-95%). No secondary caries or serious adverse events occurred. Conclusions: PICN hybrid ceramic provided superior marginal integrity and zero failures over 24 months in cervical restorations of professional ballet dancers, outperforming the self curing composite. PICN inlays are recommended for abfraction defects. The self curing composite may be considered for carious defects when light curing is problematic, but patients should be informed of higher failure risk. Longer studies are needed.

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