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Clinical Trial

PICN Versus Bioactive Composite for Cervical Restorations in Ballet Dancers

NCT: NCT07598305 · COMPLETED

NCT IDNCT07598305
StatusCOMPLETED
Start Date2021-12-09
Completion2024-12-09

Brief Summary

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.

Frequently Asked Questions

What is PICN Versus Bioactive Composite for Cervical Restorations in Ballet Dancers?

PICN Versus Bioactive Composite for Cervical Restorations in Ballet Dancers is a clinical trial registered under NCT07598305. Current status: COMPLETED.

What is the status of NCT07598305?

The current status of NCT07598305 (PICN Versus Bioactive Composite for Cervical Restorations in Ballet Dancers) is: COMPLETED.

When did PICN Versus Bioactive Composite for Cervical Restorations in Ballet Dancers start?

PICN Versus Bioactive Composite for Cervical Restorations in Ballet Dancers started on 2021-12-09.

Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.