跳至主要内容
临床试验/NCT05317039
NCT05317039Unknown不适用

Evaluation of Piezosurgical Buccal Plate Repositioning Technique for Horizontal Alveolar Ridge Augmentation Comparing Between Two Different Grafting Materials (a Randomized Clinical Trial)

Hams Hamed Abdelrahman1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2021年8月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
18
试验地点
1
主要终点
change in alveolar ridge width

研究概览

简要总结

Achieving prosthetically driven implant placement is a highly predictable treatment modality with reliable long-term results. Different surgical procedures have been used as a solution for reconstructing of the alveolar ridge with deficient volume. In the present study we demonstrate a modified alveolar ridge split technique for horizontal alveolar ridge augmentation (buccal plate repositioning technique) using the piezotome surgery. Evaluation of the effect of silica-calcium phosphate nanocomposite (SCPC) graft material versus demineralized freeze dried bone allograft (DFBA) in horizontal alveolar ridge augmentation before implant insertion will be performed.

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
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with horizontal atrophy of the posterior mandible with pristine residual alveolar crest width from 2 to 4 mm.
  • •Augmented area length in the mesial-distal direction of less than 20 mm.
  • •Adequate physically healthy condition.

排除标准

  • •A systemic disease that would contraindicate oral surgical treatment.
  • •Treated patients who had undergone therapy involving radiation
  • •Patients who had received bone resection as part of an oncological treatment after a bone augmentation procedure.
  • •Patients are subjected to intravenous and/or oral bisphosphonate therapy after the bone augmentation procedure.

研究组 & 干预措施

Group A

Experimental

Group A will be treated with the buccal plate repositioning technique and grafted with SCPC.

干预措施: silica-calcium phosphate nanocomposite SCPC (Other)

Group B

Active Comparator

Group B will be similarly managed and grafted using DFDBA

干预措施: freezed dried bone (Other)

结局指标

主要结局

change in alveolar ridge width

时间窗: at baseline and 6 months

All patients will receive a CBCT scan; immediately after surgery and at 6 months post-operatively. The images will be analyzed using OnDemand3D software (Cybermed Inc) CBCT analyzing software and compared to the pre-operative scan for alveolar ridge width evaluation.

次要结局

未报告次要终点

研究者

发起方
Hams Hamed Abdelrahman
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hams Hamed Abdelrahman

Assistant lecturer of DPH and Clinical statistician

Alexandria University

研究点 (1)

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