Clinical Performance of a Preheated Thermoviscous Bulk-Fill Composite and Two Different Indirect Composite Systems in Primary Molars: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Fédération Dentaire Internationale (FDI) criteria
研究概览
简要总结
The aim of this study was to compare the clinical performance of direct restorations with two different indirect composite systems in primary teeth.
详细描述
The aim of this study was to compare the clinical performance of a thermoviscous bulk-fill composite used in direct restorations with two different indirect composite systems in primary teeth. This randomized, controlled, assessor-blind, parallel-group design in vivo study included 158 teeth from 73 patients aged 4-10 years. The teeth were allocated into three groups: direct thermoviscous bulk-fill composite, indirect nano-hybrid composite inlay system, and indirect nano-hybrid modular composite system. Clinical evaluations were performed according to FDI criteria at 6- and 12-month follow-up, and survival comparisons were conducted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The study was carried out as a one-blinded trial, which the outcomes assessor was unaware of what material was applied to each tooth. No blinding was done during the treatment period because all treatments were performed by one dentist.
入排标准
- 年龄范围
- 4 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •children aged between 4 and 10 years,
- •classified as ASA I according to the American Society of Anesthesiologists (i.e., healthy individuals without systemic disease except for conditions not affecting general health),
- •demonstrating cooperative behavior corresponding to Frankl Behavior Rating Scale scores of 3 (positive) or 4 (definitely positive).
- •Only patients presenting with Angle Class I occlusion
- •demonstrating bilateral, balanced mastication were included in the study.
- •Teeth included in the study were required to present with Class II (MO/DO) cavities and to have an antagonist and proximal contact.
- •According to the International Caries Detection and Assessment System II (ICDAS II), teeth with scores of 4, 5, or 6 were included.
- •In addition, only teeth with a plaque index score of 0 (no plaque) or 1 (plaque not visible to the naked eye but detectable with a probe at the gingival margin)
- •a gingival index score of 0 (healthy gingiva, no inflammation) were selected
排除标准
- •patients who do not meet the inclusion criteria
- •teeth that do not meet the inclusion criteria
- •Teeth showing internal and external resorption on radiographic examination
- •Patients/guardians who declined to participate in the study and participants who did not sign the consent form
研究组 & 干预措施
direct thermoviscous bulk-fill composite
Direct composite restorations were performed using heated composite material in accordance with the manufacturer's recommendations.
干预措施: Fédération Dentaire Internationale (FDI) criteria. (Other)
direct thermoviscous bulk-fill composite
Direct composite restorations were performed using heated composite material in accordance with the manufacturer's recommendations.
干预措施: survival comparison (Other)
indirect nano-hybrid composite inlay system
Indirect restorations were fabricated extraorally using incremental layering techniques (≤2 mm) and polymerized using LED light-curing units. Additional post-curing procedures were performed according to manufacturers' instructions.
干预措施: Fédération Dentaire Internationale (FDI) criteria. (Other)
indirect nano-hybrid composite inlay system
Indirect restorations were fabricated extraorally using incremental layering techniques (≤2 mm) and polymerized using LED light-curing units. Additional post-curing procedures were performed according to manufacturers' instructions.
干预措施: survival comparison (Other)
indirect nano-hybrid modular composite system
Indirect restorations were fabricated extraorally using incremental layering techniques (≤2 mm) and polymerized using a dual-mode laboratory polymerization unit (Labolight DUO, GC, Tokyo, Japan). Additional post-curing procedures were performed according to manufacturers' instructions.
干预措施: Fédération Dentaire Internationale (FDI) criteria. (Other)
indirect nano-hybrid modular composite system
Indirect restorations were fabricated extraorally using incremental layering techniques (≤2 mm) and polymerized using a dual-mode laboratory polymerization unit (Labolight DUO, GC, Tokyo, Japan). Additional post-curing procedures were performed according to manufacturers' instructions.
干预措施: survival comparison (Other)
结局指标
主要结局
Fédération Dentaire Internationale (FDI) criteria
时间窗: Clinical evaluations were performed according to FDI criteria at 6- and 12-month follow-up
The clinical performance of restorations was evaluated using Fédération Dentaire Internationale (FDI) criteria. Restorations were assessed across functional (fracture and retention, marginal adaptation), biological (postoperative sensitivity, recurrent caries, tooth integrity, and periodontal response), and esthetic (surface polish, marginal and surface staining) domains using a five-point scale. Scores of 1-3 were considered clinically acceptable, whereas scores of 4-5 were considered clinically unacceptable and indicative of failure
次要结局
- survival comparison(6- and 12-month follow-up)
研究者
Ebru KUCUKYİLMAZ
Prof. Dr.
Izmir Katip Celebi University