Evaluation of the Clinical Performance of Universal Adhesives in Non-Carious Cervical Lesions: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Restoration survival rate at 12 months
研究概览
简要总结
The aim of this randomized controlled clinical trial is to evaluate the 12-month clinical performance of restorations placed in NCCLs using universal adhesives with different compositions according to FDI criteria.
详细描述
This controlled, randomized, single-blind clinical trial will compare the clinical effectiveness of three universal adhesive systems with different compositions in the restoration of non-carious cervical lesions. A total of 30 healthy volunteers aged 18-55 years will be included. Each participant must present with at least three vital posterior teeth with non-carious cervical lesions (≥3 lesions), with both enamel and dentin involvement and with antagonist teeth in occlusion. Each participant will receive restorations using all three adhesive systems in different teeth (split- mouth design). Randomization will be performed using a computer-generated randomization table (Research Randomizer Program). An experienced operator from the Department of Restorative Dentistry will perform all restorative procedures (AUT). Radiographs will be taken at baseline (before treatment) and at 12-, 24- and 36-month follow-up appointments to assess adaptation, marginal integrity, and proximity to the pulp. Additional radiographs will only be taken if clinically indicated (e.g., suspected endodontic involvement). Restorations will be evaluated immediately after placement, at 12-, 24- and 36-month using FDI evaluation criteria.
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
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy individuals aged 18-55 years
- •No systemic condition contraindicating restorative treatment
- •Brushing teeth at least twice daily
- •At least 20 teeth in occlusion
- •At least three vital posterior teeth with non-carious cervical lesions and antagonist teeth
- •Completed initial periodontal therapy
- •Signed informed consent
排除标准
- •Healthy individuals aged 18-55 years
- •No systemic condition contraindicating restorative treatment
- •Brushing teeth at least twice daily
- •At least 20 teeth in occlusion
- •At least three vital posterior teeth with non-carious cervical lesions and antagonist teeth
- •Completed initial periodontal therapy
- •Signed informed consent
研究组 & 干预措施
G2 Bond Universal
Enamel margins will be beveled (0.5 mm) using a flame-shaped diamond bur.Isolation will be achieved using cotton rolls and saliva ejector. Enamel surfaces will be etched with 35% phosphoric acid for 15 seconds, rinsed for 15 seconds, and dentin left slightly moist. Adhesives will be applied according to the manufacturer's instructions. A nanohybrid universal composite (OptiShade, Kerr Corporation, Orange, CA, USA) will be placed incrementally (≤2 mm layers) and light-cured. Finishing and polishing will be performed using OptiDisc discs and HiLuster polishing system (Kerr).
干预措施: G2 Bond Universal, GC Europe N.V., Leuven, Belgium (Device)
Scotchbond Universal Plus
Enamel margins will be beveled (0.5 mm) using a flame-shaped diamond bur. Isolation will be achieved using cotton rolls and saliva ejector. Enamel surfaces will be etched with 35% phosphoric acid for 15 seconds, rinsed for 15 seconds, and dentin left slightly moist. Adhesives will be applied according to the manufacturer's instructions. A nanohybrid universal composite (OptiShade, Kerr Corporation, Orange, CA, USA) will be placed incrementally (≤2 mm layers) and light-cured. Finishing and polishing will be performed using OptiDisc discs and HiLuster polishing system (Kerr).
干预措施: Scotchbond Universal Plus, 3M ESPE, St. Paul, MN, USA (Device)
Tokuyama Universal Bond II
Enamel margins will be beveled (0.5 mm) using a flame-shaped diamond bur. Isolation will be achieved using cotton rolls and saliva ejector. Enamel surfaces will be etched with 35% phosphoric acid for 15 seconds, rinsed for 15 seconds, and dentin left slightly moist. Adhesives will be applied according to the manufacturer's instructions. A nanohybrid universal composite (OptiShade, Kerr Corporation, Orange, CA, USA) will be placed incrementally (≤2 mm layers) and light-cured. Finishing and polishing will be performed using OptiDisc discs and HiLuster polishing system (Kerr).
干预措施: Tokuyama Universal Bond II, Tokuyama Dental, Tokyo, Japan (Device)
结局指标
主要结局
Restoration survival rate at 12 months
时间窗: From baseline to 12 month
Restoration survival rate at 12 months, defined as: At least 90% of restorations remaining in situ No statistically significant difference among groups according to FDI criteria
次要结局
未报告次要终点
研究者
Cansu Atalay
Principal investigator, Assoc. Prof
Hacettepe University