跳至主要内容
临床试验/NCT03607006
NCT03607006已完成不适用

3D Ridge Augmentation in the Anterior Maxillary Region Using Patient Specific Polyether Ether Ketone (PEEK) Sheets vs. Autogenous Bone Shell Technique. A Randomized Clinical Trial: Comparative Study

Ola Alaa El-Din Abd El-Monem Mohamed2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2018年7月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
14
试验地点
2
主要终点
Patient satisfaction

研究概览

简要总结

Comparative study to assess the ability of the patient specific PEEK sheets in ridge augmentation with using mixed Autogenous/Xenogenic bone graft vs the Bone Shell Technique regarding the time, accuracy and donor site morbidity .

详细描述

A- Intervention Group (Patient specific PEEK sheets)

  • Preoperative Computed tomography will be done to the patients.
  • Using special software, 3D models will be obtained and used to design the custom made PEEK sheets. The final STL (Standard Tessellation Language) files will be sent to the lab to be milled/printed.
  • Autogenous bone graft will be taken from Chin/Retromolar graft and will be mixed with xenogenic bone graft in 1:1 ratio.
  • After bone exposure, the ridge will be decorticated and the prefabricated PEEK sheets will be fixed with titanium screws and the space between the sheets and the ridge will be filled with the prepared bone graft.
  • Wounds closure will be done.
  • CT scan will be done postoperative.
  • After 6 months another CT scan will be done for evaluation and comparison. Then the titanium screws will be removed and implants will be placed.

B- Control Group (Autogenous bone shell technique)

  • Preoperative Computed tomography will be done to the patients
  • Bone graft will be harvested from the chin/retromolar region and a cortico- cancellous bone block will be obtained then divided into two pieces used as the shells.
  • The bone shells will be trimmed and adjusted to the recipient site and the remaining bone will be milled and mixed with Xenogenic bone graft with ratio 1:1
  • The bone shells will be anchored in the host bone with titanium screws and the space between the shells and the alveolar bone will be filled by the bone graft mix.
  • Wounds closure will be done.
  • CT scan will be done.
  • After 6 months another CT scan will be done for evaluation and comparison. Then the patient will go for micro screws removal along with implant placement.

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
None

盲法说明

None because the two interventions requires different preoperative preparations , both the participants and the investigator can't be blinded .

入排标准

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

入选标准

  • Adult patients with deficient alveolar bone in the anterior maxilla.
  • Patient seeking fixed prosthesis at the anterior maxillary region.
  • Highly motivated patients.
  • Good oral hygiene.
  • Patients willing for the surgical procedure and follow-up, with an informed consent.
  • Bounded anterior maxilla cases.

排除标准

  • Medically compromised patients.
  • Uncooperative patients.
  • Poor oral hygiene.
  • Periodontal diseases.
  • No history of any grafting procedure at the designated edentulous ridge.Criteria
  • Patients with any diseases that compromise bone or soft tissue healing.
  • Patients with no local pathosis that interfere with the bone healing.

结局指标

主要结局

Patient satisfaction

时间窗: 8 months

Questionnaire will be used to evaluate the satisfaction , measuring unit Binary (YES/NO)

次要结局

  • Bone quality(4-6 months post-operative)
  • Bone gain(4-6 months post-operative)
  • Soft tissue reaction(4-6 months postoperative)
  • Intraoperative time(Intraoperative)

研究者

发起方
Ola Alaa El-Din Abd El-Monem Mohamed
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ola Alaa El-Din Abd El-Monem Mohamed

Principle Investigator

Cairo University

研究点 (2)

Loading locations...

相似试验