PICN Versus Bioactive Composite for Cervical Restorations in Ballet Dancers

NCT07598305 | Completed

• 1 other identifier: 15495725682
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Ballet Dancers; Caries, Cervical

Keywords

polymer-infiltrated ceramic network; self- curing composite; cervical restoration; abfraction defect; ballet dancers; randomised controlled trial; split-mouth design; marginal integrity; USPHS criteria

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  6, 12, and 24 months post-restoration

Secondary Outcomes (3)

• Secondary caries

  6, 12, and 24 months post-restoration

• Postoperative hypersensitivity

  6, 12, and 24 months post-restoration

• Oral Health Impact Profile-14 (OHIP-14)

  Baseline (pre-restoration), 6, 12, and 24 months post-restoration

Study Arms (4)

PICN hybrid ceramic for carious cervical defects

ACTIVE COMPARATOR

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 hybrid ceramic for abfraction defects

EXPERIMENTAL

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

Self-curing bioactive composite - carious defects

ACTIVE COMPARATOR

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

Self-curing composite - abfraction defects

EXPERIMENTAL

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

Interventions

Polymer-infiltrated ceramic network (PICN) - carious DEVICE

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.

PICN hybrid ceramic for carious cervical defects

Polymer-infiltrated ceramic network (PICN) - abfraction DEVICE

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.

PICN hybrid ceramic for abfraction defects

Self-curing bioactive bulk-fill composite - carious DEVICE

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.

Self-curing bioactive composite - carious defects

Self-curing bioactive bulk-fill composite - abfraction DEVICE

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.

Self-curing composite - abfraction defects

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (1)

Kazumova

Moscow, 119048, Russia

Location

Related Publications (31)

• Carikcioglu B, Ay Simsek I, Arikan V, Sariyilmaz E. Color stability of a novel self-cure bulk-fill composite compared to light-cure bulk-fill and injectable composite resins. BMC Oral Health. 2025 Sep 29;25(1):1478. doi: 10.1186/s12903-025-06831-4.

  PMID: 41023617 BACKGROUND

• Fibryanto E, Wijaya IB, Eljabbar FD, Elline E. Comparative evaluation of volumetric polymerization shrinkage and diametral tensile strength of self-cure and light-cure composite resins: an in vitro study. Int J Prosthodont Restor Dent. 2026;16(1):17-22.

  BACKGROUND

• Laporte C, Bourgi R, Jmal H, Ben Ammar T, Hazko S, Addiego F, Sauro S, Haikel Y, Kharouf N. Mechanical, Antibacterial, and Physico-Chemical Properties of Three Different Polymer-Based Direct Restorative Materials: An In Vitro Study. Polymers (Basel). 2025 May 6;17(9):1272. doi: 10.3390/polym17091272.

  PMID: 40363056 BACKGROUND

• Thadathil Varghese J, Raju R, Farrar P, Prentice L, Prusty BG. Comparative analysis of self-cure and dual cure-dental composites on their physico-mechanical behaviour. Aust Dent J. 2024 Jun;69(2):124-138. doi: 10.1111/adj.13004. Epub 2023 Dec 22.

  PMID: 38131257 BACKGROUND

• Salem SA, Agila N. Clinical comparison of Stela chemically-cured bulk-fill composite and conventional light-cured composite in posterior restorations: a 6-month clinical study. Libyan J Med Appl Sci. 2025 Oct 14:14-21.

  BACKGROUND

• Loguercio AD, Carpio-Salvatierra B, Naupari-Villasante R, Wendlinger M, Armas-Vega A, Cavagnaro S, Leon A, Aliaga-Galvez R, Gutierrez MF. Clinical evaluation of a new chemically-cured bulk-fill composite in posterior restorations: 6-month multicenter double-blind randomized clinical trial. J Dent. 2024 Oct;149:105246. doi: 10.1016/j.jdent.2024.105246. Epub 2024 Jul 25.

  PMID: 39025426 BACKGROUND

• Loguercio AD, Carpio-Salvatierra B, Naupari-Villasante R, Armas-Vega A, Cavagnaro S, Leon A, Aliaga-Galvez R, Soares CJ, Gutierrez MF. Clinical evaluation of a new chemically-cured bulk-fill composite in posterior restorations: 18-Month multicenter double-blind randomized clinical trial. J Dent. 2025 Nov;162:106031. doi: 10.1016/j.jdent.2025.106031. Epub 2025 Aug 14.

  PMID: 40818514 BACKGROUND

• Aliberti A, Garcia-Godoy F, Borges ALS, Tribst JPM, Gasparro R, Mariniello M, Ausiello P. Calcium, phosphate and fluoride ionic release from dental restorative materials for elderly population: an in vitro analysis. Front Oral Health. 2025 Aug 11;6:1609502. doi: 10.3389/froh.2025.1609502. eCollection 2025.

  PMID: 40860792 BACKGROUND

• Albelasy EH, Raghip AG, Ismail HS. Internal adaptation and micromorphological analysis of a new self-cure resin composite. J Clin Exp Dent. 2025 Aug 1;17(8):e912-e919. doi: 10.4317/jced.62900. eCollection 2025 Aug.

  PMID: 40950526 BACKGROUND

• Bagratuni M, Bruhnke M, Bohner L, Herklotz I, Beuer F, Bose MWH, Pieralli S. Clinical performance and occlusal wear of polymer-infiltrated ceramic network and zirconia-reinforced ceramic implant-supported single crowns fabricated via a digital workflow on two titanium implant systems: a 12-month prospective randomized trial. Int J Implant Dent. 2026 Feb 20;12(1):10. doi: 10.1186/s40729-026-00671-9.

  PMID: 41714584 BACKGROUND

• Tissanavasoontra K, Tantilertanant Y, Srisawasdi S. The effect of different surface treatments of shear bond strength of repaired polymer-infiltrated ceramic network materials. Oral Sci Rep. 2025. doi:10.12982/osr.2025.052

  BACKGROUND

• Bayraktar ET, Turkmen C, Atali PY, Tarcin B, Korkut B, Yasa B. In-vitro evaluation of wear characteristics, microhardness and color stability of dental restorative CAD/CAM materials. Dent Mater J. 2024 Jan 30;43(1):74-83. doi: 10.4012/dmj.2023-071. Epub 2023 Dec 8.

  PMID: 38072413 BACKGROUND

• Mahrous AI, Salama AA, Shabaan AA, Abdou A, Radwan MM. Color stability of two different resin matrix ceramics: randomized clinical trial. BMC Oral Health. 2023 Sep 14;23(1):665. doi: 10.1186/s12903-023-03364-6.

  PMID: 37710194 BACKGROUND

• Banh W, Hughes J, Sia A, Chien DCH, Tadakamadla SK, Figueredo CM, Ahmed KE. Longevity of Polymer-Infiltrated Ceramic Network and Zirconia-Reinforced Lithium Silicate Restorations: A Systematic Review and Meta-Analysis. Materials (Basel). 2021 Sep 3;14(17):5058. doi: 10.3390/ma14175058.

  PMID: 34501148 BACKGROUND

• Kanaan M, Brabant A, Eckert GJ, Hara AT, Carvalho JC. Randomized clinical trial on the performance of direct and indirect restorations in adults with severe tooth wear: a pilot study. J Dent. 2026 Feb;165:106268. doi: 10.1016/j.jdent.2025.106268. Epub 2025 Nov 26.

  PMID: 41314372 BACKGROUND

• Pereira FM. Update on the new polymer infiltrated ceramic network material (PICN). PQDT-Global. 2019.

  BACKGROUND

• Best AM, Lang TA, Greenberg BL, Gunsolley JC, Ioannidou E; Task Force on Design and Analysis in Oral Health Research. The OHStat Guidelines for Reporting Observational Studies and Clinical Trials in Oral Health Research: Manuscript Checklist. J Endod. 2024 Nov;50(11):1655-1661. doi: 10.1016/j.joen.2024.05.007. Epub 2024 Jul 14.

  PMID: 39007795 BACKGROUND

• Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c332. doi: 10.1136/bmj.c332.

  PMID: 20332509 BACKGROUND

• Sun J, Jiang J, Huang Z, Ma X, Shen T, Pan J, Bi Z. Smart biomaterials in restorative dentistry: Recent advances and future perspectives. Mater Today Bio. 2025 Sep 29;35:102349. doi: 10.1016/j.mtbio.2025.102349. eCollection 2025 Dec.

  PMID: 41089722 BACKGROUND

• Kontiza A, Kartsonakis IA. Smart Composite Materials with Self-Healing Properties: A Review on Design and Applications. Polymers (Basel). 2024 Jul 25;16(15):2115. doi: 10.3390/polym16152115.

  PMID: 39125142 BACKGROUND

• Alghauli MA, Al-Gabri RS, Keshk A, Mirah MA, Alqutaibi AY. Clinical Complications and Survival Rate of Resin Matrix Ceramic Restorations: A Systematic Review and Meta-Analysis. J Esthet Restor Dent. 2025 Jul;37(7):1721-1739. doi: 10.1111/jerd.13471. Epub 2025 Apr 4.

  PMID: 40186393 BACKGROUND

• Oudkerk J, Herman R, Eldafrawy M, Wulfman C, Ernst M, Vanheusden A, Mainjot A. Intraoral wear of PICN CAD-CAM composite restorations used in severe tooth wear treatment: 5-year results of a prospective clinical study using 3D profilometry. Dent Mater. 2024 Jul;40(7):1056-1063. doi: 10.1016/j.dental.2024.05.015. Epub 2024 May 18.

  PMID: 38762399 BACKGROUND

• Comba A, Baldi A, Carossa M, Michelotto Tempesta R, Garino E, Llubani X, Rozzi D, Mikonis J, Paolone G, Scotti N. Post-Fatigue Fracture Resistance of Lithium Disilicate and Polymer-Infiltrated Ceramic Network Indirect Restorations over Endodontically-Treated Molars with Different Preparation Designs: An In-Vitro Study. Polymers (Basel). 2022 Nov 23;14(23):5084. doi: 10.3390/polym14235084.

  PMID: 36501478 BACKGROUND

• Kopetsky IS, Vasiliev YuL. The role of individual protective dental mouthguards in the prevention of sports injuries in the maxillofacial region. Dental Forum. 2016;(3):32-34.

  BACKGROUND

• Aleksandrov MT, Olesova VN, Dmitrieva EF, Namiot ED, Artyomova OA, Akhmedov AN, Razumova SN. [Integrated assessment of hygienic condition of the oral cavity]. Stomatologiia (Mosk). 2020;99(4):21-26. doi: 10.17116/stomat20209904121. Russian.

  PMID: 32692515 BACKGROUND

• Makeeva IM, Avdeenko OE. [Peculiarities of oral health of organized collectives and professional communities]. Stomatologiia (Mosk). 2016;95(1):63-66. doi: 10.17116/stomat201695163-66. Russian.

  PMID: 27182563 BACKGROUND

• Timoshina MD, Sevbitov AV, Borisov VV, et al. Assessment of the level of oral hygiene and the condition of dental hard tissues among ballet dancers of various age groups. Medical Alphabet. 2023;(1):24-27.

  BACKGROUND

• Derevyanchenko SP, Makedonova YuA, Klurfeld VD, et al. Comparative assessment of the effectiveness of restorations in the cervical region of teeth by direct and indirect method. Bulletin of the Volgograd State Medical University. 2023;20(4):44-48.

  BACKGROUND

• Mironov SN, Danshina SD, Timoshina MD, et al. Features of dental status in ballet dancers. Indo American Journal of Pharmaceutical Sciences. 2019;6(1):1-4.

  BACKGROUND

• Zangieva OT, Sevbitov AV, Epifanov SA, et al. Features of functional and structural changes of the temporomandibular joint in ballet dancers. Bulletin of the Volgograd State Medical University. 2024;21(1):93-99.

  BACKGROUND

• Bragin EA, Dolgaev AA, Bragareva NV. Features of examination and treatment of patients with complete dentition and occlusive disorders. Fundamental Research. 2014;(2):44-47.

  BACKGROUND

MeSH Terms

Conditions

Root Caries

Condition Hierarchy (Ancestors)

Dental Caries; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Aglaya B Kazumova

  I.M. Sechenov First Moscow State Medical University (Sechenov University)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 20, 2026
• Study Start: December 9, 2021
• Primary Completion: December 9, 2022
• Study Completion: December 9, 2024
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)