Evaluation of Resorption, Safety, and Efficacy of Absorbable Collagen Membrane in Preventing Significant Bone Loss Following GBR (Guided Bone Regeneration) Procedure.

Hyundai Bioland Co., Ltd.0 个研究点目标入组 50 人开始时间: 2024年12月16日最近更新: 2024年8月26日

适应症

试验速览

阶段: 不适用
状态: 尚未招募
发起方: Hyundai Bioland Co., Ltd.
入组人数: 50
主要终点: Assessment of collagen membrane's - efficacy and safety.

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The clinical study aims to assess the long-term safety and efficacy of the interventional medical device. The clinical study will enrol up to 50 patients aged 18 years and older, who meet specific inclusion and exclusion criteria designed to ensure patient safety and reliable data collection.

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 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

未提供

排除标准

未提供

结局指标

主要结局

Assessment of collagen membrane's - efficacy and safety.

时间窗: 6 months after intervention

Remnants of the collagen membrane, new blood vessels formation, and the absence of inflammation in histological results.

次要结局

Assessment of collagen membrane's - safety.(From the beginning till the end.)
Change in bone dimensions(Baseline, 6 and 12 months after intervention)
Complication rate(7 days and 6 months after intervention)
VAS scale(On the day of intervention and after 1, 2, 3 days. Satisfaction - on the day of intervention.)

研究者

发起方

Hyundai Bioland Co., Ltd.

申办方类型

Industry

责任方

Sponsor

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