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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Marginal integrity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: Polymer-infiltrated ceramic network (PICN) - carious (Device)
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.
干预措施: Polymer-infiltrated ceramic network (PICN) - abfraction (Device)
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).
干预措施: Self-curing bioactive bulk-fill composite - carious (Device)
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.
干预措施: Self-curing bioactive bulk-fill composite - abfraction (Device)
结局指标
主要结局
Marginal integrity
时间窗: 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)
时间窗: 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.
次要结局
- 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)