Clinical Evaluation of Posterior Direct Restoration in Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- restoration failure
研究概览
简要总结
The present study aims to evaluate the performance of direct restorations with bulk fill resins in molars with great structural loss, with endodontic treatment. The behavior of class II restorations in 68 molars endodontically treated with bulk fill resin and incremental technique will be evaluated by means of a randomized clinical trial with a two-year follow-up. This project aims to evaluate the performance of this new restorative strategy that can greatly contribute to restorations of posterior teeth.
详细描述
Sixty-eight endodontically treated molars were restored in 54 adolescents (10-18 years old, mean= 14.0 +- 2.4). Teeth were randomly assigned to the incremental filling technique (Filtek Z230/Vitremer, 3M-ESPE, n = 31) or high viscosity bulk fill technique (Filtek Bulk Fill Posterior, 3M-ESPE, n = 37). The restorations were clinically evaluated at baseline, 12 and 24 months by two independent raters using modified United States Public Health Service criteria. Data analysis included descriptive statistics, Mann-Whitney and Friedman non-parametric tests, and Generalized Estimating Equation (GEE) analysis.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adolescents with necessity of endodontic treatment in molar teeth, to be aged between 10 and 18 years;
- •Patients that require direct restorations in Class II MOD cavities in molar teeth;
- •Patients with medical history that does not compromise the evolution of the results;
- •Patients that have a habit of oral hygiene involving brushing teeth at least once a day;
- •Patients that have normal periodontal condition against the probing parameters.
排除标准
- •Patients with some chronic disease with oral manifestations;
- •Patients who present some serious oral pathology;
- •Patients with no oral hygiene;
- •Patients with allergies to any material that will be used on this study;
- •Patients presenting with signs or symptoms of bruxism and dental tightening;
- •Patients with teeth that will be used as a pillar for removable prosthesis or fixed partial dentures;
- •Patients with teeth with porcelain restorations directly opposite the tooth that will receive the restoration.
研究组 & 干预措施
Incremental filling technique
Glass ionomer in the pulp chamber and incremental filling technique using composite resin
干预措施: Direct composite resin (Procedure)
Bulk Fill
Bulk fill composite resin filling all the cavity
干预措施: Direct composite resin (Procedure)
结局指标
主要结局
restoration failure
时间窗: 2 years
material fraction
次要结局
- marginal staining(2 years)
研究者
Renata Afonso da Silva Pereira
PHD student
Federal University of Uberlandia