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临床试验/NCT06850649
NCT06850649已完成不适用

Clinical Performance of 3D-Printed vs. Milled Endocrowns: A 2 Years Prospective Randomized Clinical Trial

Gulcan COSKUN AKAR1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2023年5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
已完成
发起方
入组人数
33
试验地点
1
主要终点
Clinical Outcomes

研究概览

简要总结

The goal of this clinical trial is to examine the durability of endocrowns, created using various materials and manufacturing techniques with a fully digital workflow, and their ability to maintain functionality and aesthetics in the oral cavity.

The main questions it aims to answer were does effect of different materials on clinical success?

详细描述

Based on the power analysis, it was determined that restorations would be applied to 11 teeth in each of the three material groups (lithium-disilicate reinforced glass-ceramic, polymer-infiltrated ceramic, and 3D-printed permanent hybrid resin). A total of 33 teeth received endocrown restorations.

The digital impressions of the patients receiving endocrown restorations were recorded using an intraoral optical scanner and sent to a specialised dental laboratory. For two of the groups (lithium disilicate-reinforced glass-ceramic, polymer-infiltrated ceramic), restorations were fabricated using block milling, while for the third group (permanent hybrid resin), restorations were produced through 3D printing. The restorations were cemented adhesively. The restorations were evaluated using the Modified FDI and Modified USPHS criteria at baseline (0) and at the 6-month follow-up, and the data were subjected to statistical analysis.

At the 6-month evaluation, no statistically significant difference in colour match was observed for any of the Modified USPHS criteria. All endocrowns produced with the three different materials survived and showed clinical success at the 6 and 24 months follow-up. Nevertheless, additional clinical studies with extended follow-up durations are required.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Must be a lower or upper molar tooth
  • •Must be periodontal healthy
  • •There must be at least two axial walls in the relevant tooth
  • •Gingival steps should be at gum level
  • •There must be neighboring teeth mesial and distal to the relevant tooth.
  • •The place where it occludes must be the opposing tooth and the tooth must be a natural or filled tooth without a prosthesis.
  • •No systemic acut or chronic conditions (Thyroid disease, Alzheimer's Disease, Insulin dependent diabetes, etc.)

排除标准

  • •Inadequate oral hygiene, bleeding on probing, pocket deeper than 3 mm mobility presence
  • •Sensitivity to percussion after root canal treatment
  • •Insufficient enamel tissue remaining in the relevant tooth
  • •Presence of radiographically abnormal periodontal space
  • •Teeth with inadequate bone support
  • •Teeth with root resorption and fracture

研究组 & 干预措施

Endocrown Materials

Experimental

IPS Empress CAD Vita Enamic VarseoSmile Crown Plus

干预措施: endocrowns (Other)

结局指标

主要结局

Clinical Outcomes

时间窗: 24 month

Restorations were checked clinically at the time of delivery and 6 months later. A 0.15 mm probe (DEPPELER 150EX, Rolle, Switzerland) was used for the controls. Modified USPHS were used in the evaluations. The modified USPHS criteria were recorded as Alpha (A), Bravo (B), Charlie (C), Delta (D), and the modified FDI criteria were recorded as very good, good, adequate, unsatisfactory, and failed. Marginal Discolouration, Marginal Integrity, Surface Texture, Wear, Postoperative Sensitivity and Recurrent Caries as Modified USPS Criteria were evaluated. In the study, the headings of the result measurement tables will be created as follows: Comparison of Baseline Modified USPHS Values According to Groups

次要结局

未报告次要终点

研究者

发起方
Gulcan COSKUN AKAR
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Gulcan COSKUN AKAR

Ege University Scientific Research Project

Ege University

研究点 (1)

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