TCTR20230427005已完成2 期
Clinical, Patient-Reported outcomes and Efficacy of Static Computer-Assisted Sinus Floor Augmentation: A Randomized Controlled Trial.
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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