Endocrowns vs.Ceramic Onlays With Filling and Fiber Pins Used in Endodontically Treated Teeth- Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Survival of restorations
研究概览
简要总结
Objective: To evaluate the immediate and mediate outcomes of endocrowns and onlay ceramic restorations with glass fiber pin in endodontically treated teeth. Material and methods: A randomized controlled clinical trial, a double-blind (patient and examiner) is conducted by one trained and calibrated operators who perform all restorative procedures. The restorations are evaluated longitudinally by a blind and calibrated examiner using the USPHS. A total of 20 patients will be randomly assigned to each group for a total of 40 patients. The randomization sequence will be generated (www.sealedenvelope.com) and to ensure the confidentiality of the allocation, this will be used opaque, sealed and numbered envelopes in series. These will be kept with an independent researcher for the moment of inclusion of the subjects. In the group of onlays, the teeth receive a fiberglass pin in the main root canal and composite resin filling. In the group of endocrown, only the restoration fill the pulp chamber. The parts are milled in IPS e-max CAD (Ivoclar Vivadent) and cemented with the Multilink cementation system (Ivoclar Vivadent). The immediate clinical (focused in restoration and patient) and mediate (radiographic and clinical) outcomes will be compared between the groups. Survival and success rates will be defined in 24 months. Survival will be established by Kaplan-Meier survival curve and log-rank can be conducted to identify as variables associated with as failures over time. Multivariate analysis with the Cox regression models will be condutcted for the determination of failure predictors. For all analyzes, the significance value will be adjusted to 5%.
详细描述
Study design - ethical and methodological aspects This study is an integral part of an umbrella project, in which the primary outcome is the longevity of prosthetic treatments, whereas patient-centered secondary outcomes are dealt with in the current study. The study protocol was approved by the Research Ethics Committee, following the Consolidated Standards of Reporting of Trials (CONSORT and CONSORT PRO) guidelines (Calvert et al., 2013; Moher et al., 2012), and registered at clinicaltrials.gov (NCT03064516).
This double-blind, parallel-arm randomized clinical trial, with a 1:1 allocation ratio, was conducted by a previously trained operator, who performed all the restorative procedures.
Survival rate of inlay/onlay ceramic restorations (96.6% after 24 months) was the primary outcome considered for sample size calculation (Peumans et al., 2010). Therefore, a clinically significant difference of 15% is expected for longevity between the groups. So, adopting a significance level of 0.05 and a 0.80 power, considering one tooth per patient, and using a two-tailed test for noninferiority trials, adding 20% for possible losses (dropout), the final number of teeth per group was 20, corresponding to a total of 40 teeth.
Participants - recruitment, eligibility, randomization, and allocation The patients were recruited by one of the researchers (SM) based on history-taking, clinical examination, and radiographic exams using a sample of patients from the Military Police Dental Center (São Paulo, Brazil) treated in 2017. The clinical steps were carried out in a private dental office.
Eligible patients were randomly assigned to one of the parallel arms of the study. The randomization sequence was generated (www.sealedenvelope.com) and allocation concealment was ensured by the use of sealed brown envelopes numbered serially and kept in possession of an independent researcher until they were opened by the operator at the beginning of treatment. The contents of the envelope indicated the experimental group to which the patient would be assigned: Endocrown group (test) or Partial coverage ceramic restoration + fiber post group (PCCR+post- control).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Presence of molars or pre molars with endodontic treatment with at least 1 face (buccal or lingual) or 1 cusp with adequate thickness of 3 mm;
- •Presence of opposing teeth and normal occlusion;
- •Supragingival margin after preparation;
- •Volunteers with good oral hygiene (no active caries, gingivitis, periodontal disease or any other disease in the soft or hard tissues of the oral cavity);
- •The selected teeth should not present restorations, cracks, hypoplasias or caries lesions in the adjacent remaining faces;
- •Not being in orthodontic treatment;
- •Be at least 18 years old.
排除标准
- •Patients will be excluded with special needs, using orthodontics devices and / or systemic diseases which may affect the oral cavity;
- •Teeth that undergo radiographic or clinical examination with painful symptomatology, unsatisfactory endodontic treatment, mobility, presence of abscess or fistula next to the tooth, teeth with restorations, sealants or enamel formation defects or signs of periapical alteration will also be excluded;
- •Volunteers smokers and pregnant women; 5) Volunteers without agenda compatible with the research schedule.
研究组 & 干预措施
Endocrown
Restorations with ceramic endocrown in endodontically treated teeth
干预措施: Endocrown (Procedure)
Onlay and fiber pin
Restorations with onlay ceramic and glass fiber pin in endodontically treated teeth
干预措施: Onlay and fiber pin (Procedure)
结局指标
主要结局
Survival of restorations
时间窗: Up to 24 months
To evaluate the survival of different restorative treatments.
次要结局
- Scale to discomfort(Immediately to restoration procedure)
- Cost-efficacy analysis by total value of treatment in relation to efficacy(Up to 24 months)
- Questionnaire of Oral health quality of life (OHIP)(Up to 24 months)
研究者
Susana Morimoto
Clinical Professor
Universidade Ibirapuera