跳至主要内容
临床试验/DRKS00022182
DRKS00022182已完成4 期

Clinical performance of posterior 3-unit zirconia Fixed Partial Dentures - Performance of zirconia restoration

3M Oral Care0 个研究点目标入组 22 人开始时间: 2020年6月16日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
22

研究概览

简要总结

Despite the current pandemic situation, all planned patients could be enrolled into the study and baseline evaluations could be carried out. No dropouts were reported. Overall, 22 patients were enrolled in the study and passed the BASELINE-evaluation. For baseline all FDI criteria were clinically acceptable. Periodontal probing depth was considered as clinically normal. 21 patients could be examined in the course of the 1 year, 2 year and 3 year follow-ups. One patient did not show up each. Survival was 100%. Two non-serious AE were reported before the 2 year and one before the 3 year follow-up respectively. All FDI criteria were rated clinically acceptable. Changes to the parameters, e.g., in terms of marginal fit, could be explained to some extent by small individual variations in measurement by the evaluators. Periodontal probing depth was considered physiological. The patients’ general rating of the treatment, which was conducted after the 1 year follow-up was “very good”.

研究设计

研究类型
Interventional
分配方式
N/a: Single Arm Study
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 99 Years(—)
性别
All

入选标准

  • 1.Subjects in need of posterior three-unit bridge
  • 2.Age 18-99
  • 3.Subjects with healthy / treated periodontal status (max. degree of movement 1)
  • 4.Subject agrees to participate in the study and signs informed consent

排除标准

  • 1.Subject has known allergies to any product used during this study
  • 2.Subject won´t be available for a study duration of 3 years
  • 3.Untreated periodontitis
  • 4.Patient participates in another dental clinical study
  • 5. Pregnant and / or lactating women

研究者

发起方
3M Oral Care

相似试验