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临床试验/NCT03527953
NCT03527953已完成不适用

Clinical Evaluation of Different Bulk-fill Restorative Resin Restorations

Hacettepe University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2013年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Clinical evaluation of different restorative resins in class II cavities on posterior teeth according to the modified USPHS criteria

研究概览

简要总结

The aim of this study is to evaluate the clinical performance of three different bulk-fill restorative resin materials; a bulk fill resin composite, a flowable bulk fill resin composite and a fiber-reinforced resin in Class II restorations over a period of 24 months.

详细描述

The objective of this study is to evaluate the 24-month clinical performance of three different bulk-fill restorative resin materials in Class II restorations. Forty patients with at least three approximal lesions in premolar and molar teeth will be participated in the study. A total of 120 Class II cavities will be restored using Tetric EvoCeram Bulk Fill (n=40), SureFil SDR flow + Ceram X mono (n=40), and everX Posterior + G-aenial Posterior (n=40) with their respective adhesives according to the manufacturers' instructions. All restorations will be placed by one operator. The restorations will be evaluated at baseline and at 6, 12, 18, and 24 months using modified USPHS criteria by one examiner. The restoration groups for each category will be compared using Pearson's chi-square test, while Cochran's Q test will be used to compare the changes across different time points within each restorative material (p<0.05).

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 (Participant)

盲法说明

single

入排标准

年龄范围
20 Years 至 41 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who accept to participate and sign the informed consent
  • Patients who have at least three similar-sized approximal primary caries lesions in premolar and molar teeth.
  • The teeth to be restored had a normal occlusal relationship with natural dentition and had adjacent tooth contact and had a normal response to a vitality test with no periapical pathology

排除标准

  • Patients who don't accept to participate and sign the informed consent
  • Patients who have a history of adverse reaction to the test materials
  • Patients who are pregnant or lactating, have fewer than 20 teeth
  • Patients who have poor oral hygiene, have severe or chronic periodontal disease, have heavy bruxism

研究组 & 干预措施

Tetric EvoCeram BulkFill resin

Active Comparator

Randomly applied

干预措施: Tetric EvoCeram Bulkfill (Other)

Surefil SDR Flowable bulk-fill resin

Active Comparator

Randomly applied

干预措施: Surefil SDR Flowable bulkfill (Other)

everX fiber-reinforced resin

Active Comparator

Randomly applied

干预措施: everX fiber-reinforced resin (Other)

结局指标

主要结局

Clinical evaluation of different restorative resins in class II cavities on posterior teeth according to the modified USPHS criteria

时间窗: 2 years

Long-term clinical success of different restorative resins in class II cavities on posterior teeth

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

A Ruya Yazici

Professor

Hacettepe University

研究点 (2)

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