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
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-centered Outcomes - 2
研究概览
简要总结
The primary aim of the trial is 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.
The secondary aims of the trial is to evaluate the effect of systemic antibiotic administration on postsurgical complications, in patients undergoing oral implant therapy with simultaneous lateral approach sinus floor elevation and guided bone regeneration (GBR).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Medically healthy adult: ASA (American Society of Anesthesiologists) 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 (Nonsteroidal anti-inflammatory drugs) 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)
- •General contraindications against implant treatment or augmentative procedures (e.g. immunodeficiency, advanced systemic diseases, corticosteroid medication)
- •Those taking Bisphosphonates/anti-angiogenic/RANKL (Receptor activator of nuclear factor kappa-Β Ligand) 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
- •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
研究组 & 干预措施
Test: Amoxicillin
干预措施: Amoxicillin (Drug)
Comparator: Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Patient-centered Outcomes - 2
时间窗: days 1-7 and 14
Change in discomfort of the sinuses (nosebleed, nasal congestion, rhinorrhea, feeling of pressure, hyposmia)
Patient-centered Outcomes - 1
时间窗: days 1-7 and 14
Change in visual analogue scores (VAS) on the wound (pain, swelling, bruising, haematoma, bleeding) Intensity of bleeding, swelling, pain and bruising on a score from 1(mild) to 10(severe).
次要结局
未报告次要终点