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临床试验/NCT05551481
NCT05551481已完成不适用

2 Year Follow-up of Indirect Resin Composite Restorations Luted With Different Adhesive Resin Cement: A Randomized Clinical Trial

Istanbul Medipol University Hospital2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年2月10日最近更新:
适应症

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
Endocrowns FDI evaluation

研究概览

简要总结

Objective: To evaluate the clinical performance of indirect resin composite restorations, which were luted with two different resin cement, in posterior teeth for up to 2 years.

Methods: From February 2017 to May 2017, a total of 43 patients (21 men, 22 women; mean age.), received 48 onlay restorations made of laboratory-processed indirect composite (Gradia, GC, Japan). 27 onlay restorations (Group A) were luted using an etch and rinse resin cement (Variolink II, Ivoclar Vivadent) and 22 onlay restorations (Group B) were luted using a self-adhesive resin cement (Relyx U200, 3M ESPE). Patients were followed until May 2019. Two independent calibrated examiners evaluated the restorations at 3-time points: 2 weeks after placement (baseline), 6 months, and then annually, using the modified USPHS/FDI criteria.

详细描述

Study design The ethical committee of Istanbul Medipol University approved this clinical study. Patients were given written informed consent to participate before treatment and agreed to a recall program at baseline 2 weeks, 6 months, and thereafter annually. All restorative procedures were carried out by one experienced dentist from the Department of Restorative Dentistry at Istanbul Medipol University.

Inclusion and exclusion criteria

Patients in need of removal of old large amalgam restorations or having extensive caries lesions were recruited for the study. Inclusion and exclusion criteria were as follows:

Adults of at least 18 years of age, with good oral hygiene, having an antagonist tooth in occlusion, being mentally in a good state to provide written consent to participate in the clinical study, and willing to attend the scheduled follow-up appointments. Exclusion criteria included the presence of teeth with severe periodontal problems, high caries risk, and bruxism.

Cavities were prepared according to common principles, which included an occlusal reduction of 1.5-2 mm with a wide isthmus and rounded occlusal-axial angles, and an axial wall of 1.5 mm in thickness. Where possible, the gingival margins were prepared entirely in enamel at the cemento-enamel junction, and cavities for overlays included both buccal and lingual/palatal cusps. Both cavity types (onlays and overlays) were prepared with rounded internal angles, with a divergence of 6-15° between the walls and margins with a 90° cave surface.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (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

入选标准

  • Patients in need of removal of old large amalgam restorations or having extensive caries lesions were recruited for the study.
  • Adults of at least 18 years of age, with good oral hygiene, having an antagonist tooth in occlusion, being mentally in a good state to provide written consent to participate in the clinical study, and willing to attend the scheduled follow-up appointments.

排除标准

  • Exclusion criteria included the presence of teeth with severe periodontal problems, high caries risk, and bruxism.

结局指标

主要结局

Endocrowns FDI evaluation

时间窗: 2 year

this clinical trial aimed to evaluate posterior teeth restored with indirect resin composites and compare clinical performances of two resin cement (one etch and rinse and one self-adhesive) 2 weeks and 6, 12, 24 months, and 5 years after the luting of indirect resin composite restorations using the modified USPHS/FDI criteria.

次要结局

  • Aesthetic :Functional :Biological :Vitality-resin cement(2 weeks and 6, 12 months and 2 year)

研究者

发起方
Istanbul Medipol University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

yeldaerdem

Dr.

Istanbul Medipol University Hospital

研究点 (2)

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