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临床试验/NCT06125938
NCT06125938招募中不适用

Comparative Study Between Autogenous Bone Block and Tent Pole Technique for Augmentation of Atrophic Anterior Maxilla A Randomized Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2023年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
24
试验地点
1
主要终点
Bone Gain

研究概览

简要总结

The goal of this clinical trial is to compare in patients with atrophied anterior maxilla, bone augmentation techniques ( gold standard bone block and tent pole technique).

The main question it aims to answer is :

Does screw tent pole technique provides better bone gain than autogenous bone block in atrophied anterior maxilla?

  • primary objective to assess amount of bone gain
  • secondary objective assess bone quality Participants will be randomly divided into two groups study group ( tent pole technique) and control group ( bone block) - each group will be followed up monthly for soft tissue dehiscence and after 6 month to assess bone gain and bone quality and then implant placement.

详细描述

• Research question: Does screw tent pole technique provides better bone gain than autogenous bone block in atrophied anterior maxilla?

• Rationale for conducting the research: Several methods have been developed for the augmentation of the deficient bone volume. These include Guided Bone Regeneration (GBR) with barrier membranes, onlay bone grafting, ridge splitting and distraction osteogenesis.

The screw tent-pole method is an effective technique to achieve initial reconstruction of alveolar bone deficiencies. Previous studies have proven that screw tent pole technique is recommended in reconstruction of atrophied alveolar bone and its good outcome in contrary to other bone graft techniques.

This study aim to compare the outcome of screw tent pole technique to conventional gold standard technique of block bone grafts in atrophied anterior maxilla.

• Primary and secondary objectives:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

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

入选标准

  • systemically healthy patients (American Society of Anesthesiologists -ASA I and II); older than 18 years
  • Patients with atrophic anterior maxilla ,with initial ridge wi¬dth of ≤ 5 mm and moderate bone height as diagnosed at the time of digital implant planning
  • No intraoral soft and hard tissue pathology.
  • Cone Beam Computer Tomography scan before and after bone augmentation.
  • Apprehensive to be in the study

排除标准

  • Bad oral hygiene.
  • smokers (>10 cigarettes/day);
  • Existence of a bone metabolic disease; currently taking drugs that might influence bone metabolism
  • Radiotherapy or chemotherapy for malignancy.

结局指标

主要结局

Bone Gain

时间窗: 6 month

to assess amount of bone gain before and after 6 month of the surgical procedure

次要结局

  • Bone quality evaluation(6 month post-operative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Youmna Mohamed Mahmoud Hassan Abdelhady

master candidate

Cairo University

研究点 (1)

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