Impact of Patients Risk Factors, Type of Dental Material and Dental Technique on the Longevity of Aesthetic Dental Restorations
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Success of the restorations
研究概览
简要总结
The objective of this double-blind randomized clinical trial is to evaluate the influence of caries risk, occlusal stress and missing teeth on anterior restorations over a 10 years follow up period. 300 teeth will be randomized according to two adhesive systems: Single Bond 2 and Single Bond Universal (3M ESPE); and two composite resins: nanoparticulated (Filtek ™ Z-350- 3M ESPE) and nanohybrid (IPS Empress Direct - Ivoclar Vivadent). The randomization will be stratified according to the risk of caries and cavity type. The primary outcomes will be longevity, annual failure rate (AFR) and the success of the restorations, and the secondary outcome will be causes for restorations' failure.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with restorative needs in anterior teeth;
- •Patients able to understand and sign the informed consent form;
- •Patients willing to return to follow up.
排除标准
- •Patients who had a need for Class III and Class IV restorations that did not involve at least 1/3 of the tooth;
- •Patients under orthodontic treatment;
- •Patients with a compromised general health condition, presenting a greater risk than ASA II, according to the ASA-PS (American Society of Anesthesiologists - Physical Status);
- •Patients who had no occlusal contact with an opposing tooth and/or crown;
- •Patient with absence of bilateral balanced occlusion;
- •Patient with deep caries lesions in close contact with the dental pulp and in need of expectant treatment or direct pulp capping;
- •Patients with post-retained need in anterior teeth.
研究组 & 干预措施
Nanoparticulated composite - self-etch
干预措施: Restorations with nanoparticulated composites and self etch adhesives (Procedure)
Nanoparticulated composite - total-etch
干预措施: Restorations with nanoparticulated composites and total-etch adhesives (Procedure)
Nanohybrid composite - self-etch
干预措施: Restorations with nanohybrid composites and self etch adhesives (Procedure)
Nanohybrid composite - total-etch
干预措施: Restorations with nanohybrid composites and total-etch adhesives (Procedure)
结局指标
主要结局
Success of the restorations
时间窗: Changes in the dental restorations status compared to baseline will be assessed yearly up to 10 years.
Success of the restoration is defined as any case where the restoration remains functional in the mouth at the time of evaluation, without any need of new interventions, and attending the patients demands. The restorations were evaluated shortly after baseline and in prospective periods through a direct clinical inspection, with an explorer probe and a clinical mirror, according to the criteria for clinical evaluation of restorations proposed by the FDI (International Dental Federation) (Hickel et al., 2010), the risks of caries and occlusal stress were also evaluated again.
Survival of the restorations
时间窗: Changes in the dental restorations status compared to baseline will be assessed yearly up to 10 years.
Survival of the restoration is defined as any case where the restoration remains functional in the mouth at the time of evaluation, regardless of need of small interventions, such as repair or refurbishment. The restorations were evaluated shortly after baseline and in prospective periods through a direct clinical inspection, with an explorer probe and a clinical mirror, according to the criteria for clinical evaluation of restorations proposed by the FDI (International Dental Federation) (Hickel et al., 2010), the risks of caries and occlusal stress were also evaluated again. Two trained and calibrated evaluators, unrelated to making the restorations, blinded to the type of material used, independently performed the clinical evaluations.
次要结局
- Patient satisfaction with the treatment(Changes in the patient's satisfaction status compared to baseline will be assessed yearly up to 10 years.)
研究者
Maximiliano Sergio Cenci
Associate Professor, Principal Investigator
Federal University of Pelotas