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临床试验/NCT06177899
NCT06177899已完成不适用

A Novel Approach for Horizontal Augmentation With Split Box: A Method That Combines Split Bone Block and Ridge Split Techniques

Marmara University1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2023年1月20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
41
试验地点
1
主要终点
Vertical changes in the alveolar bone

研究概览

简要总结

The goal of this clinical study is to investigate the effectiveness of the split-box technique in systemically healthy, non-smoking, over 18 years of age, participants with narrow crests (<5mm bone width) and adequate bone height (>12mm). The main questions it aims to answer are:

  • The primary objective of the present study is to investigate the effectiveness of the split-box technique by evaluating the change in width and height of the alveolar bone.
  • The secondary objective is to evaluate the superiority of the split-box technique and its modifications in terms of the amount of bone gain.

According to the 3D topography of the alveolar ridge of the patients before augmentation, split box or one of its modifications, reverse split box or sliding split box techniques were selected and applied. (split box was applied if the bone thickness was more than 3 mm at the top of the crest and did not increase towards the lower border at the alveolar bone, reverse split box technique was applied if the bone thickness was more than 3 mm at the top of the crest and increased towards the lower border at the alveolar bone, sliding split box was applied if the bone thickness was less than 3 mm at the top of the crest but the bone thickness increases towards the lower border at the alveolar bone.)

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
22 Years 至 73 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • To be older than 18 years of age
  • To be systemically healthy
  • To be non-smokers
  • Having narrow crests (<5 mm bone width)
  • Having adequate bone height (>12 mm)
  • Having cone-beam computed tomography scans before surgery and five months after augmentation

排除标准

  • Having bone diseases,
  • A history of neck or head radiotherapy
  • Receiving steroids, bisphosphonates or chemotherapeutic drugs
  • Being pregnancy
  • Having narrow bone thickness in the crest (<3 mm), those in whom this thickness did not increase toward the lower border of the alveolar bone
  • Patients with a history of infection or exposure after augmentation

结局指标

主要结局

Vertical changes in the alveolar bone

时间窗: 5 months

To determine whether there was vertical bone loss during horizontal augmentation, the height of the alveolar ridge (ARH) was measured. To measure ARH, a line was created between the anatomical landmark and the highest point of the crest, and the length of this line was measured in the pre- and post-operative tomography.

Horizontal changes in the alveolar bone

时间窗: 5 months

To determine the horizontal changes in the alveolar bone, thickness was measured at two different levels. The measurements were titled as follows: crestal width (CW) and screw level width (SLW). To measure CW, measurements were made horizontally at the highest point of the crest in pre- and post-operative tomography. To measure SLW, in the post-operative tomography, the bone thickness at the screw level was measured horizontally and recorded. In addition, the distance between the anatomical landmark (mandibular basis, mandibular foramen, lower border of nasal or sinus cavity) and the screw level was also measured and recorded. The main goal of this measurement was to provide a reference for SLW measurement on preoperative cone-beam computed tomography (CBCT), since there were no screws. After the measurements in the postoperative CBCT were made, SLW was also made in the preoperative imaging.

次要结局

  • Difference in bone thickness gain at the top of the crest (CW) between the 3 groups(5 months)
  • Difference in bone loss at alveolar ridge height (ARH) between 3 groups(5 months)
  • Difference in bone thickness gain at the top of the screw level (SLW) between the 3 groups(5 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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