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临床试验/TCTR20230427005
TCTR20230427005已完成2 期

Clinical, Patient-Reported outcomes and Efficacy of Static Computer-Assisted Sinus Floor Augmentation: A Randomized Controlled Trial.

Chulalongkorn University0 个研究点目标入组 40 人开始时间: 2023年4月27日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
40

研究概览

简要总结

o statistically significant difference was found between the two groups with regards to PROMs and intra-, post-operative complications, apart from higher level of swelling for SCA-SFA patients on day 2 after surgery. The use of SCA-SFA significantly reduced the time needed to conduct the window osteotomy (SCA 1113.80 + 730.41 sec vs SCA-SFA 685.50 + 285.28 sec) and the total surgery duration (SCA 4193.30 + 1204.98 sec vs SCA-SFA 3374.35 + 960.45 sec).

研究设计

研究类型
Interventional

入排标准

年龄范围
21 Years 至 N/A (No limit)(—)
性别
All

入选标准

  • 1.Medically healthy adult (ASA I-II) and age more than 21 years old
  • 2.Non-smoker or previous smoker (quit more than 5 years) or light smoker with less than 10 cigarettes/day
  • 3.Edentulous spaces in posterior maxilla in 1 or 2 posterior quadrants with an alveolar bone defect which requires lateral approach sinus floor augmentation for 1-3 implant placement (residual crestal height less than 6 mm)
  • 4.Absence of sinus membrane pathology or rhinosinusitis or other pathology requiring management

排除标准

  • 1. Medically compromised subjects (ASA III-V)
  • 2.General contraindications against implant treatment or augmentative procedures
  • (immunodeficiency or advanced systemic diseases or corticosteroid medication)
  • 3.Patients taking oral bisphosphonates longer than 5 years /anti-angiogenic/RANKL inhibitor medications or receiving local radiotherapy
  • 4.Heavy smoker or previous heavy smoker (quit less than 5 years or more than 10 cigarettes/day)
  • 5.Acute/Chronic unmanaged symptomatic sinusitis
  • 6.Type 1 implant placement (immediate implant placement following extraction)
  • 7.Need for simultaneous soft tissue augmentation.
  • 8.Residual bone height more than 6 mm
  • 9.Subjects aged less than 21 years old

研究者

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