An interventional study of Polymer-infiltrated ceramic network (PICN) - carious and Polymer-infiltrated ceramic network (PICN) - abfraction in Ballet Dancers and Caries, Cervical, sponsored by I.M. Sechenov First Moscow State Medical University. Completed at 1 site in Russia. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-05-20.
Sponsored by I.M. Sechenov First Moscow State Medical University · Not applicable, Interventional, and Treatment
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.
This prospective, split-mouth, randomized controlled trial was conducted at the Centre for Sports and Ballet Trauma and Rehabilitation of the Priorov National Medical Research Centre of Traumatology and Orthopaedics (Moscow, Russian Federation) in collaboration with the Borovskiy Institute of Dentistry, Sechenov University. The protocol was approved by the Local Ethics Committee of Sechenov University (Protocol No. 22-21, 9 December 2021) and followed CONSORT 2010 and OHStat guidelines.
Participant recruitment and screening:
Professional ballet dancers (current or retired, ≥10 years of professional experience, aged 18-50 years) were screened for the presence of at least two non-adjacent cervical defects (Class V carious or abfraction) located in different quadrants. Each defect had a depth ≥1.5 mm and width ≤4 mm. Teeth had to be vital, with probing depth ≤3 mm and no pulpal pathology. Exclusion criteria included severe bruxism requiring occlusal splint, uncontrolled systemic disease, pregnancy/lactation, known allergy to study materials, and inability to attend follow-up.
Randomization and blinding:
A computer-generated randomization sequence (1:1 allocation, block size 4) assigned the two materials to the two defects within each participant. Allocation was concealed using sequentially numbered, opaque, sealed envelopes opened immediately before the procedure. Participants and the outcome assessor (calibrated dentist) were blinded to material assignment; the operating dentist could not be blinded due to handling differences.
Restorative procedures (detailed):
All restorations were placed by a single operator under local anesthesia (4% articaine with epinephrine 1:100,000).
PICN group (VITA Enamic): After minimally invasive cavity preparation (caries removal and etching for carious defects; no preparation for abfraction), a polyvinyl siloxane impression was taken. PICN inlays were fabricated in a dental laboratory. At a second visit, the inlay was bonded with dual-cure resin cement (G-CEM ONE) following the manufacturer's instructions.
Self-curing composite group (Stela, SDI): The two-step protocol was applied: Stela Primer for 15 seconds, followed by bulk placement of Stela (single increment). No light curing was used. After setting, finishing was performed with fine diamond burs and polishing discs.
Outcome assessment schedule:
Patients were recalled at 6, 12, and 24 months post-restoration. Two calibrated, blinded examiners (intra-examiner kappa=0.86, inter-examiner kappa=0.82) independently assessed:
Marginal integrity using modified USPHS criteria (Alpha, Bravo, Charlie, Delta; failure = Charlie or Delta).
Dye penetration (Borovsky-Aksamit test): 2% methylene blue applied for 2 minutes, rinsed, and scored as present/absent.
Secondary caries (clinical + radiographic).
Postoperative hypersensitivity (Visual Analogue Scale, 0-100 mm).
Oral Health Impact Profile-14 (OHIP-14) at baseline, 6, 12, and 24 months.
Statistical analysis summary (detailed):
Paired binary outcomes were analyzed using McNemar's test with Holm-Bonferroni correction across three time points (α=0.017) and two co-primary outcomes (α=0.025). Fisher's exact or chi-square tests were used for group comparisons. Kaplan-Meier survival curves with log-rank test compared restoration survival. Subgroup analyses by defect type were exploratory; uncorrected p-values are reported. Sample size (40 defects, 20 per material) was calculated a priori (G*Power) to detect a 30% difference in marginal defects with 80% power, assuming 20% dropout (actual dropout 0%). Analyses followed intention-to-treat.
Data management:
Anonymized data are stored at Sechenov University. No missing data occurred. The dataset is available from the corresponding author upon reasonable request and ethics approval.
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This study's enrollment of 20 is below the median of 62 across 35 interventional studies indexed under Root Caries.
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A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
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Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
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Polymer-infiltrated ceramic network (PICN, VITA Enamic) indirect inlay bonded with dual-cure resin cement (G-CEM ONE). Applied to carious cervical lesions (Class V) in professional ballet dancers. Cavity preparation: conventional caries removal, etching, impression, laboratory fabrication. Follow-up: 6,12,24 months. Outcomes: marginal integrity (USPHS), dye penetration, secondary caries, hypersensitivity, OHIP-14.
Device: Polymer-infiltrated ceramic network (PICN) - carious
PICN (VITA Enamic) inlay bonded with dual-cure resin cement. Applied to non-carious cervical lesions (abfraction) without additional mechanical preparation - existing defect shape used as cavity form. High occlusal load model (ballet dancers). Assessment at 6,12,24 months: USPHS marginal integrity, dye penetration (Borovsky-Aksamit), survival analysis.
Device: Polymer-infiltrated ceramic network (PICN) - abfraction
Smart bioactive self-curing bulk-fill composite (Stela, SDI). Hydroperoxide-based initiator system, no light curing. Applied to carious cervical lesions following two-step protocol: Stela Primer (15s), then bulk placement. Finishing with diamond burs and polishing discs. Outcomes at 6,12,24 months: marginal integrity, dye penetration, secondary caries, hypersensitivity, patient-reported outcomes (OHIP-14).
Device: Self-curing bioactive bulk-fill composite - carious
Stela self-curing composite placed in abfraction cervical lesions without mechanical preparation. Cervical sclerotic dentin substrate. Polymerisation shrinkage stress minimized by chemical cure. Clinical evaluation at 6,12,24 months using modified USPHS criteria. Primary endpoint: marginal integrity. Secondary: dye penetration, restoration survival (Kaplan-Meier), failure rate comparison with PICN.
Device: Self-curing bioactive bulk-fill composite - abfraction
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.
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.
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.
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.
Marginal integrity
Marginal integrity evaluated using modified United States Public Health Service (USPHS) criteria (Alpha, Bravo, Charlie, Delta) at 6, 12, and 24 months. Failure defined as Charlie (gap extending to dentin) or Delta (restoration loss). Clinical examination with dental mirror, probe, and additional light source. Two calibrated blinded examiners (intra-examiner kappa=0.86, inter-examiner kappa=0.82). Ordinal scale: Alpha, Bravo, Charlie, Delta
Time frame: 6, 12, and 24 months post-restoration
Dye penetration (Borovsky-Aksamit test)
Dye penetration assessed by Borovsky-Aksamit test: 2% methylene blue solution applied to the restoration margin for 2 minutes, then rinsed. Presence (+) or absence (-) of dye at the tooth-restoration interface recorded dichotomously.
Time frame: 6, 12, and 24 months post-restoration
Secondary caries
Presence or absence of secondary (recurrent) caries adjacent to the cervical restoration, detected by clinical and radiographic assessment.
Time frame: 6, 12, and 24 months post-restoration
Postoperative hypersensitivity
Patient-reported tooth sensitivity to thermal (cold/hot) or osmotic (sweet/sour) stimuli following restoration placement. Patients mark their level of hypersensitivity on a 100 mm Visual Analogue Scale (VAS) from 0 mm (no hypersensitivity) to 100 mm (severe hypersensitivity).
Time frame: 6, 12, and 24 months post-restoration
Oral Health Impact Profile-14 (OHIP-14)
Patient-reported oral health-related quality of life measured by the OHIP-14 questionnaire, which includes 14 items across seven domains (functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, handicap). Each item scored 0-4 (never, hardly ever, occasionally, fairly often, very often). Total score is sum of all items. Worse outcome (poorer oral health-related quality of life)
Time frame: Baseline (pre-restoration), 6, 12, and 24 months post-restoration
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