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临床试验/NCT06209905
NCT06209905已完成不适用

Comparison of Khoury Technique Versus Titanium Reinforced PTFE Membrane in 3D Alveolar Bone Augmentation in Atrophic Posterior Mandible

Delta University for Science and Technology2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2021年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
2
主要终点
Bone volume in cubic millimeters

研究概览

简要总结

In patients with missed lower posterior teeth and resorbed lower jaw, the study aimed at restoring the jaw's height and width to accommodate placing dental implants. The study was designed as a clinical trial with two arms; control group and study group. In the control group, titanium-reinforced polytetrafluoroethylene (Ti PTFE) membrane was used to secure the grafted bone mixture in the recipient site. While in the study group, bone-plate technique (Khoury technique) for bone restoration was used to secure the grafted bone mixture as well. The donor bone was the lower jaw (for bone particles and bone-plate harvesting) and bovine bone particles mixed together to form the graft mixture. Patients were monitored for six months and assessed by X-rays. The outcome variables were volume and height of gained bone in cubic millimeters and millimeters, respectively.

详细描述

This study targeted bone augmentation in atrophic posterior mandible. Two groups were assigned. The first group included titanium-reinforced polytetrafluoroethylene (Ti PTFE) membrane as a rigid modality to achieve guided-bone regeneration (GBR): A mixture of autogenous bone (scrapped from the mandibular external oblique ridge) and bovine xenograft was administered on the atrophic recipient area after decortication by low-speed reducing drills, and covered with the mentioned membrane. The second group utilized rigid bone-plates (a bone block was harvested from the mandibular external oblique ridge, then splitted into two plates; one fixated buccally and the other fixated occlusally by bone screws), and the same bone mixture was prepared and introduced as in the first group. All procedures were operated under local anesthesia in a minor oral surgical setting.

Follow-up time intervals were the first postoperative day, and the sixth postoperative month. Two outcome variables were assessed; gained bone volume and gained bone height.

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, Outcomes Assessor)

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

  • Age above 18 years old.
  • Good oral hygiene.
  • Missing mandibular posterior teeth.
  • No history of bruxism or para-functional habits.
  • Residual alveolar ridge height cannot accommodate dental implant placement.
  • Patients prepared to comply with the follow-up and maintenance program.
  • Agreement and signing the informed consent.

排除标准

  • Systemic diseases that may contraindicate the surgery or affect soft tissue or bone healing.
  • Heavy smoking (more than 20 cigarettes/day).
  • Intraosseous pathological lesion at the intended grafting site.
  • Gingival inflammation at the intended implant site.
  • Periodontal diseases affecting teeth adjacent to the edentulous space.
  • Inadequate inter-arch space after the indented vertical augmentation.

结局指标

主要结局

Bone volume in cubic millimeters

时间窗: Sixth postoperative month

Volume of the gained bone was assessed by cone-beam computed tomography (CBCT)

次要结局

  • Vertical bone height in millimeters(Sixth postoperative month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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