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临床试验/NCT06443476
NCT06443476招募中不适用

A Comparative Study Between Tenting Abutment Technique Versus Screw"Tent-Pole" Technique for Augmentation of Posterior Atrophic Mandible Randomized Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 16 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
16
试验地点
1
主要终点
height gained and width gained

研究概览

简要总结

To evaluate a novel method using a designed tenting abutment to reduce number of surgeries and the edentulous healing period is shortened. In addition, to prevent vertical and horizontal collapse of the bone graft and minimizes resorption of the bone graft during the healing the atrophic posterior mandible.

The tent pole provides excellent mechanical properties; stability & fixation, yet very poor features to preserve the integrity of the soft tissue.

Using the tenting abutment technique will help preserve the soft tissue and decrease the amount of dehiscence that might accompany the use of the tent pole.

详细描述

Augmentation of insufficient bone volume can be brought about by different methods, including, particulate and block grafting materials, guided Bone Regeneration with or without growth and differentiation factors, ridge splitting, expansion and distraction osteogenesis, either alone or in combination. These techniques may be used for horizontal/vertical ridge augmentation.

Xenograft bone has been utilized for the reconstruction of large 3-dimensional defects because it has no donor site morbidity and is of an unlimited volume in quantity.

Guided bone regeneration (GBR) describes the use of membranes to regenerate bony defects. A membrane for GBR needs to be biocompatible, cell occlusive, non-toxic, moldable and possess space-maintaining properties including stability.

  • e. Explanation for choice of comparators (conventional titanium mesh): Tent pole offers superb mechanical properties for guided bone regeneration treatment in larger areas and it is regarded one of the most available covers for guided bone regeneration yet one of the cheapest.

B. Objectives:

  • a. Aim of the study:

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
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with atrophic posterior mandible.
  • Both sexes.
  • No intraoral soft and hard tissue pathology.
  • No systemic condition that contraindicates implant placement

排除标准

  • Local criteria:
  • Untreated gingivitis, periodontitis.
  • Insufficient oral hygiene.
  • Previous radiation therapy for the head and neck neoplasia, or bone augmentation to implant site..
  • Systemic criteria:
  • Systemic disorders.
  • Heavy smoking of more than 20 cigarettes per day.
  • Bone pathology.
  • ·Psychiatric problems. Emotional instability. Unrealistic aesthetic demands.

结局指标

主要结局

height gained and width gained

时间窗: before and post operative four months

height gained and width gained Measure unit milimerter (mm) Measure device :CBCT

次要结局

  • Soft tissue dehiscence(after one month)

研究者

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

Alaa Mohmmed Salem Hafedh

PRINCIPLE INVESTIGATOR

Cairo University

研究点 (1)

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