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临床试验/NCT06627621
NCT06627621已完成早期 1 期

EVALUATION of the EFFICACY of E-POLYCAPROLACTONE-CONTAINING MEMBRANE in ALVEOLAR BONE REGENERATION: a RETROSPECTIVE STUDY

cem üngör2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2021年3月8日最近更新:
适应症

试验速览

阶段
早期 1 期
状态
已完成
发起方
入组人数
4
试验地点
2
主要终点
Shapiro-Wilk test

研究概览

简要总结

This study aimed to evaluate the effectiveness of synthetic polycaprolactone (PCL) bioscaffold membranes used for alveolar augmentation in maxillofacial surgery for increasing the amount of newly formed bone after three-dimensional application.

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 Months 至 80 Months(Child)
性别
All
接受健康志愿者

入选标准

  • (1) patients aged >18 years without any systemic disease or with an established systemic disease that precluded the surgical procedure; (2) patients whose bone deficiency was augmented with PCL scaffolds; (3) patients with an indication for dental implant-supported prosthesis who lacked sufficient bone for dental implants according to cone beam computed tomography (CBCT) evaluation and, therefore, needed bone augmentation; and (4) patients with preoperative and postoperative images.

排除标准

  • patients (1) with uncontrolled systemic diseases, (2) who had undergone radiation therapy, (3) who were female and pregnant, (4) who had previously undergone any surgical procedure related to augmentation in the area of the defect, (5) who had incomplete files or lacked pre- and post-treatment radiologic records, or (6) who had psychological problems.

结局指标

主要结局

Shapiro-Wilk test

时间窗: From enrollment to the end of treatment at 6 months

Descriptive statistics are presented as median, mean, standard deviation, minimum-maximum, standard error, and frequency values

次要结局

未报告次要终点

研究者

发起方
cem üngör
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

cem üngör

Professor Dr Cem UNGOR

Karadeniz Technical University

研究点 (2)

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