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临床试验/NCT06311422
NCT06311422进行中(未招募)不适用

A 3-Year Clinical Evaluation Of Endocrown Restorations With Two Different Materials Using The Computer-Aided Design/ Computer-Aided Manufacture (Cad/Cam) System

Hacettepe University2 个研究点 分布在 2 个国家目标入组 74 人开始时间: 2020年3月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
74
试验地点
2
主要终点
Clinical performance of two materials

研究概览

简要总结

The clinical performance of two different materials in endodontically treated teeth produced with CAD/CAM system will be evaluated and compared. After obtaining a signed informed consert form from all the patients, all restorations will be placed by a single clinician. All endocrown restorations will be produced using the same CAD/CAM system. 52 restorations will be fabricated using Lava Ultimate (LU, 3M Espe, Seefeld, Germany) blocks and 38 restorations will be fabricated using Celtra Duo (CD, Dentsply Sirona, York, PA, USA) blocks. All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using modified United States Public Health Service (USPHS) criteria after baseline, 6,12,36, 48, 60 months. Descriptive statistics will be performed using Chi-square and Fisher exact test.

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, Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Good general health
  • Patients older than 18
  • Teeth must receive endodontic therapy before restoration
  • The periodontal condition had to be stabilized before restoration
  • No subject complained of discomfort in teeth
  • Radiograph revealing alveolar bone resorption of less than a third and no shadow around the periapical tissues
  • Participants who provided writen informed consent were recruited in collaboration

排除标准

  • Any teeth with microcracks or fracture lines
  • Affected teeth without completed root canal treatment
  • The defect was less than ¼ of crown or more than ¾ of the crown and the margin of the residual crown was more than 1 mm below the gingival level
  • Poor oral hygiene and periodontal status which persisted or worsened after periodontal therapy and education
  • Bruxism or clenching patients
  • Poor general health or pregnancy
  • Patients who have read the informed consent form and refused to be included in the study

研究组 & 干预措施

Lava Ultimate block

Experimental

Resin nanoceramic block

干预措施: resin nanoceramic block (Other)

Celtra Duo block

Active Comparator

zirconia-reinforced lithium silicate block

干预措施: zirconia-reinforced lithium silicate (Other)

结局指标

主要结局

Clinical performance of two materials

时间窗: 36 months

36 months-Modified United States Public Health Service

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

Simge Canatan

principal investigator

Hacettepe University

研究点 (2)

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