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临床试验/NCT06296459
NCT06296459已完成不适用

Radiographic Changes in the Maxillary Sinus Following Closed Sinus Augmentation

The University of Texas Health Science Center at San Antonio2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2022年9月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
2
主要终点
Dimensional Change in augmentation at 10mm

研究概览

简要总结

A closed sinus augmentation is performed for dental implant placement.

详细描述

Patients who are diagnosed as needing sinus augmentation by a closed approach for dental implant placement will be recruited. A cone beam computed tomography (CBCT) study is the standard of care prior to dental implant placement. However, following closed sinus augmentation nothing is known as to the extent of augmentation in the medial to lateral (cross-sectional) dimension. Patients will have a low volume CBCT taken immediately postsurgically, and again at the six-month postoperative visit to determine the dimensional changes in the augmentation. These images will be compared to standard periapical radiographs at the same time points.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Partially edentulous patients (18-85 years of age) requiring maxillary sinus augmentation for dental implant placement.
  • At least 5mm of native bone below the maxillary sinus.
  • Nonsmokers.
  • If diabetic, current HbA1C <7.0 (less than or equal to 7.0)

排除标准

  • Maxillary sinus disease.
  • Pregnancy or attempting to become pregnant.
  • Diseases that affect bone metabolism.
  • Use of medications known to affect bone metabolism.
  • Tobacco use.
  • Alcoholism or recreational drug use.
  • Diabetic with HbA1C >7.0 (above 7.0)

研究组 & 干预措施

Low volume CBCT

Active Comparator

Radiographic low volume cone beam computed tomography used to plan implant placement

干预措施: 3D R100 scanner (Other)

Standard periapical radiographs

Placebo Comparator

Standard radiography used to plan implant placement

干预措施: Conventional Radiograph (Other)

结局指标

主要结局

Dimensional Change in augmentation at 10mm

时间窗: Baseline immediately postoperatively and at 6 months

Determine the morphologic changes to maxillary sinus anatomy three dimensionally when a closed sinus augmentation is performed for dental implant placement at 10 mm from alveolar crest.

Dimensional Change in augmentation at 12mm

时间窗: Baseline immediately postoperatively and at 6 months

Determine the morphologic changes to maxillary sinus anatomy three dimensionally when a closed sinus augmentation is performed for dental implant placement at 12 mm from alveolar crest.

Dimensional Change in augmentation at 8mm

时间窗: Baseline immediately postoperatively and at 6 months

Determine the morphologic changes to maxillary sinus anatomy three dimensionally when a closed sinus augmentation is performed for dental implant placement at 8mm from alveolar crest.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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