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临床试验/NCT07028606
NCT07028606进行中(未招募)1 期

Effect of Arginine - Glycine - Aspartic Acid (RGD) Hydrogel on Vertical Ridge Augmentation Using Computer-guided Sandwich Osteotomy Technique, With Xenograft and Simultaneous Implant Placement

Al-Azhar University1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2024年5月9日最近更新:
干预措施
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
12
试验地点
1
主要终点
Effect of RGD on volumetric bone changes

研究概览

简要总结

Researcher will introduce the trial to patients and provide full explanation of its aim and benefits in Arabic language. Patients will then be able to have an informed discussion with the researcher. Researcher will obtain written consent from patients willing to participate in the trial

详细描述

This protocol and the template informed consent form will be reviewed by the Ethics Committee of Scientific Research -Faculty of Oral and Dental Medicine- Al-Azhar University.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Other
盲法
Single (Outcomes Assessor)

盲法说明

Patients will be randomly assigned to either test or control groups using computer generated randomization (www.randomizer.org)

入排标准

年龄范围
30 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Sandwich technique with xenograft, collagen membrane and simultaneous implant placement

Placebo Comparator

(Control group) will receive computer-guided sandwich osteotomy technique with xenograft, collagen membrane and simultaneous implant placement.

干预措施: Sandwich technique with xenograft, collagen membrane and simultaneous implant placement. (Procedure)

Sandwich technique with (RGD), xenograft, collagen membrane and simultaneous implant placement

Active Comparator

(Study group) will receive computer-guided sandwich osteotomy technique with (RGD), xenograft, collagen membrane and simultaneous implant placement.

干预措施: Sandwich technique with (RGD), xenograft, collagen membrane and simultaneous implant placement. (Biological)

结局指标

主要结局

Effect of RGD on volumetric bone changes

时间窗: Preoperative Cone beam computed tomography (CBCT) with minimal field of view will be taken for (implant treatment plan), immediately after surgery, at time of loading and 6 months after loading.

Cone beam computed tomography with minimal field of view was taken immediately after surgery, immediately before loading (6 months) and 6 months after loading to evaluate volumetric changes.

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

Ahmed Khairy morsi

Assistant Iecturer at Oral Medicine, Periodontology, Oral Radiology and Oral Diagnosis, Faculty of Oral and Dental Medicine, Al-Azhar University, Principal Investigator.

Al-Azhar University

研究点 (1)

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