2024-511366-36-00招募中4 期
The effect of systemic antibiotics on post-surgical complications and patient-centered outcomes in patients undergoing implant surgery with guided bone regeneration and simultaneous sinus floor elevation
Medical University Of Graz1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年9月8日最近更新:
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Patient Reported Outcome Measures (PROMs): Visual analogue scores VAS (0-10) on the wound (bleeding, swelling, pain, bruising (haematoma)) and discomfort of the sinuses (nosebleed, nasal congestion, rhinorrhea (excessive nasal discharge including posterior nasal drip), feeling of pressure, hyposmia (reduction in smell)) on days 1-7 & 14 .
研究概览
简要总结
To evaluate the effect of systemic antibiotic administration compared to placebo in patients undergoing oral implant therapy with simultaneous lateral sinus floor elevation and guided bone regeneration (GBR) in regard to patient-centered outcomes.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Medically healthy adult (ASA classification I-II), age ≥ 21 years old
- •Non-smoker, previous smoker (quit ≥ 5 years); light smoker with less than 10 cigarettes/ day
- •Not allergic to Amoxicillin/Penicillin antibiotics, NSAIDS or corn-starch
- •Edentulous spaces in the posterior maxilla in one or 2 posterior quadrants with an alveolar bone defect requiring sinus floor elevation and allowing implant placement of up to 3 dental implants and simultaneous GBR (residual crest height 3-5 mm; per implant site (Felice et al. 2012; Park et al. 2019).
- •Absence of signs of pathology of the sinus membrane and acute sinusitis requiring ongoing management
排除标准
- •Medically compromised subjects (ASA classification III-V)
- •Type 1 implant placement (immediate implant placement following extraction)
- •Need for simultaneous soft tissue augmentation
- •Residual bone height of > 5mm.
- •Subjects aged < 21 years old
- •General contraindications against implant treatment or augmentative procedures (e.g. immunodeficiency, advanced systemic diseases, corticosteroid medication)
- •Those taking Bisphosphonates/anti-angiogenic/RANKL inhibitor medications or receiving local radio-therapy
- •Heavy smoker or previous heavy smoker (quit < 5 years; ≥ 10 cigarettes/day)
- •Allergic to Amoxicillin or Penicillin antibiotics, NSAIDS and / or corn starch
- •Use of any form of antibiotics in the last 3 months or subjects requiring regular antibiotic prophylaxis prior to dental treatment
- •Pregnant or breast feeding. Self-declared intend to conceive (A pregnancy test will be performed for all female patients).
- •Need for 2 stage sinus augmentation
- •Acute or unmanaged symptomatic sinusitis
结局指标
主要结局
Patient Reported Outcome Measures (PROMs): Visual analogue scores VAS (0-10) on the wound (bleeding, swelling, pain, bruising (haematoma)) and discomfort of the sinuses (nosebleed, nasal congestion, rhinorrhea (excessive nasal discharge including posterior nasal drip), feeling of pressure, hyposmia (reduction in smell)) on days 1-7 & 14 .
Patient Reported Outcome Measures (PROMs): Visual analogue scores VAS (0-10) on the wound (bleeding, swelling, pain, bruising (haematoma)) and discomfort of the sinuses (nosebleed, nasal congestion, rhinorrhea (excessive nasal discharge including posterior nasal drip), feeling of pressure, hyposmia (reduction in smell)) on days 1-7 & 14 .
次要结局
- Clinical recordings of post-surgical complications at week 2, 4, 16-20 and 6 months after crown- installation on: flap closure/dehiscence, pain/sensitivity on palpation, swelling (obliteration of the sulcus), suppuration/purulent discharge, Implant stability (at initial placement and 2nd stage surgery).
研究者
Assoz.-Prof. PD DDr. Michael Payer
Scientific
Medical University Of Graz
研究点 (1)
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