PICN Versus Bioactive Composite for Cervical Restorations in Ballet Dancers

NCT07598305 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-05-20

No results posted yet for this study

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.

Conditions

  • Ballet Dancers
  • Caries, Cervical

Interventions

DEVICE

Polymer-infiltrated ceramic network (PICN) - carious

Indirect PICN inlay (VITA Enamic) fabricated from CAD/CAM block. Cavity preparation: conventional caries removal, etching 37% H3PO4 (15s enamel, 10s dentin). Impression with polyvinyl siloxane. Bonding with dual-cure resin cement (G-CEM ONE). Applied to carious cervical lesions (Class V) in professional ballet dancers. Assessment at 6,12,24 months.

DEVICE

Polymer-infiltrated ceramic network (PICN) - abfraction

Indirect PICN inlay (VITA Enamic) bonded with dual-cure resin cement. No additional mechanical preparation - existing abfraction defect shape used as cavity form. Application to non-carious cervical lesions (abfraction) in ballet dancers. High occlusal load model. Follow-up: 6,12,24 months with USPHS criteria and dye penetration test.

DEVICE

Self-curing bioactive bulk-fill composite - carious

Direct self-curing composite (Stela, SDI) using hydroperoxide-based initiator system. No light curing. Two-step protocol: Stela Primer applied for 15 seconds, then bulk placement in single increment. Caries removal, etching as per manufacturer. Finishing with diamond burs and polishing discs. Applied to carious cervical Class V defects.

DEVICE

Self-curing bioactive bulk-fill composite - abfraction

Direct self-curing composite (Stela) placed in abfraction lesions without mechanical preparation. Cervical sclerotic dentin substrate. Self-curing eliminates polymerisation shrinkage stress. Protocol: primer 15s, bulk fill. Outcomes at 6,12,24 months: marginal integrity (USPHS), dye penetration, survival analysis. Suitable for patients with high occlusal loads.

Sponsors & Collaborators

  • I.M. Sechenov First Moscow State Medical University

    lead OTHER

Principal Investigators

  • Aglaya B Kazumova · I.M. Sechenov First Moscow State Medical University (Sechenov University)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-09
Primary Completion
2022-12-09
Completion
2024-12-09

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07598305 on ClinicalTrials.gov