Ballet DancersNCT07598305
PICN Versus Bioactive Composite for Cervical Restorations in Ballet Dancers
A study testing Polymer-infiltrated ceramic network (PICN) - carious, Polymer-infiltrated ceramic network (PICN) - abfraction and Self-curing bioactive bulk-fill composite - carious in people with Ballet Dancers and Caries, Cervical, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial summary
Background and Objectives: Professional ballet dancers endure high occlusal loads, increasing cervical defect prevalence. Conventional composites fail frequently under such conditions. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Ballet Dancers, Caries, Cervical
- What is being tested?
- Polymer-infiltrated ceramic network (PICN) - carious, Polymer-infiltrated ceramic network (PICN) - abfraction and Self-curing bioactive bulk-fill composite - carious
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteRussia
- Study dates
- 9 Dec 2021to 9 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Ballet Dancers, Caries, Cervical
- Being tested
- Polymer-infiltrated ceramic network (PICN) - carious, Polymer-infiltrated ceramic network (PICN) - abfraction, Self-curing bioactive bulk-fill composite - carious, Self-curing bioactive bulk-fill composite - abfraction
- Keywords
- polymer-infiltrated ceramic network, self- curing composite, cervical restoration, abfraction defect, ballet dancers, randomised controlled trial, split-mouth design, marginal integrity, USPHS criteria
- Medical subject headings
- Root Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polymer-infiltrated ceramic network (PICN) - cariousDevice
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.
Polymer-infiltrated ceramic network (PICN) - abfractionDevice
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.
Self-curing bioactive bulk-fill composite - cariousDevice
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 bulk-fill composite - abfractionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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). Receives: 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. Receives: Device: Self-curing bioactive bulk-fill composite - abfraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 6, 12, and 24 months post-restoration
Secondary outcomes (3)
Secondary caries
Presence or absence of secondary (recurrent) caries adjacent to the cervical restoration, detected by clinical and radiographic assessment.
Measured: 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).
Measured: 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)
Measured: Baseline (pre-restoration), 6, 12, and 24 months post-restoration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start9 Dec 2021
- Primary completion9 Dec 2022
- Study completion9 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Ballet DancersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aglaya B Kazumova, Principal investigator, I.M. Sechenov First Moscow State Medical University (Sechenov University)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07598305
- Sponsor's protocol ID
- 15495725682
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41023617Fibryanto 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.
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.
PubMed 40363056Thadathil 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.
PubMed 38131257Salem 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.
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.
PubMed 39025426Loguercio 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.
PubMed 40818514Aliberti 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.
PubMed 40860792Albelasy 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.
PubMed 40950526Bagratuni 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.
PubMed 41714584Tissanavasoontra 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
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.
PubMed 38072413Mahrous 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.
PubMed 37710194Banh 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.
PubMed 34501148Kanaan 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.
PubMed 41314372
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07598305
- Acronym / sponsor ID
- 15495725682
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 9 Dec 2021 (actual)
- Primary completion
- 9 Dec 2022 (actual)
- Study completion
- 9 Dec 2024 (actual)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PICN hybrid ceramic for carious cervical defects | Active comparator | Device: Polymer-infiltrated ceramic network (PICN) - cariousPolymer-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. |
| PICN hybrid ceramic for abfraction defects | Experimental | Device: Polymer-infiltrated ceramic network (PICN) - abfractionPICN (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. |
| Self-curing bioactive composite - carious defects | Active comparator | Device: Self-curing bioactive bulk-fill composite - cariousSmart 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). |
| Self-curing composite - abfraction defects | Experimental | Device: Self-curing bioactive bulk-fill composite - abfractionStela 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polymer-infiltrated ceramic network (PICN) - cariousIndirect 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 | PICN hybrid ceramic for carious cervical defects |
| Polymer-infiltrated ceramic network (PICN) - abfractionIndirect 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 | PICN hybrid ceramic for abfraction defects |
| Self-curing bioactive bulk-fill composite - cariousDirect 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 composite - carious defects |
| Self-curing bioactive bulk-fill composite - abfractionDirect 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. | Device | Self-curing composite - abfraction defects |
Primary outcome
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
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.
3 secondary outcomes
Secondary caries
Time frame: 6, 12, and 24 months post-restoration
Postoperative hypersensitivity
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Background: PubMed 41023617Carikcioglu 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.
- BackgroundFibryanto 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: PubMed 40363056Laporte 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.
- Background: PubMed 38131257Thadathil 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.
- BackgroundSalem 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: PubMed 39025426Loguercio 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.
- Background: PubMed 40818514Loguercio 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.
- Background: PubMed 40860792Aliberti 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.
- Background: PubMed 40950526Albelasy 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.
- Background: PubMed 41714584Bagratuni 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.
- BackgroundTissanavasoontra 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: PubMed 38072413Bayraktar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aglaya B Kazumova principal investigator
I.M. Sechenov First Moscow State Medical University (Sechenov University)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polymer-infiltrated ceramic network (PICN) - carious, Polymer-infiltrated ceramic network (PICN) - abfraction and Self-curing bioactive bulk-fill composite - carious in people with Ballet Dancers and Caries, Cervical, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Marginal integrity (time frame: 6, 12, and 24 months post-restoration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07598305, which also lists 31 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.