PICN Versus Bioactive Composite for Cervical Restorations in Ballet Dancers

May 17, 2026 updated by: I.M. Sechenov First Moscow State Medical University

Polymer-Infiltrated Ceramic Network Versus Smart Bioactive Self-Curing Composite for Cervical Restorations in Profession-al Ballet Dancers: A 24-Month Split-Mouth Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russia
      • Moscow, Russia, 119048
        • Kazumova

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Current or retired professional ballet dancer with at least ten years of professional experience
  • Age 18 to 50 years
  • At least two non-adjacent cervical defects (Class V carious lesions or abfraction defects) located in different quadrants
  • Each defect depth ≥1.5 mm and width ≤4 mm
  • Teeth are vital, free of active periodontal disease (probing depth ≤3 mm), and without clinical or radiographic signs of pulpal pathology

Exclusion Criteria:

  • Severe bruxism requiring occlusal splint therapy
  • Uncontrolled systemic diseases (e.g., diabetes mellitus, autoimmune disorders)
  • Pregnancy or lactation
  • Known allergic reactions to any component of the restorative materials (PICN or Stela composite)
  • Inability to attend scheduled follow-up visits (6, 12, 24 months)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PICN hybrid ceramic for carious cervical defects
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
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.
Experimental: PICN hybrid ceramic for abfraction defects
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
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.
Active Comparator: Self-curing bioactive composite - carious defects
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
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.
Experimental: Self-curing composite - abfraction defects
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Marginal integrity
Time Frame: 6, 12, and 24 months post-restoration

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
6, 12, and 24 months post-restoration
Dye penetration (Borovsky-Aksamit test)
Time Frame: 6, 12, and 24 months post-restoration
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.
6, 12, and 24 months post-restoration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary caries
Time Frame: 6, 12, and 24 months post-restoration
Presence or absence of secondary (recurrent) caries adjacent to the cervical restoration, detected by clinical and radiographic assessment.
6, 12, and 24 months post-restoration
Postoperative hypersensitivity
Time Frame: 6, 12, and 24 months post-restoration
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).
6, 12, and 24 months post-restoration
Oral Health Impact Profile-14 (OHIP-14)
Time Frame: Baseline (pre-restoration), 6, 12, and 24 months post-restoration
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)
Baseline (pre-restoration), 6, 12, and 24 months post-restoration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

I.M. Sechenov First Moscow State Medical University

Investigators

  • Principal Investigator: Aglaya B Kazumova, I.M. Sechenov First Moscow State Medical University (Sechenov University)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 9, 2021

Primary Completion (Actual)

December 9, 2022

Study Completion (Actual)

December 9, 2024

Study Registration Dates

First Submitted

May 12, 2026

First Submitted That Met QC Criteria

May 17, 2026

First Posted (Actual)

May 20, 2026

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 17, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15495725682

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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