2023-510391-31-00招募中4 期
The effect of different antibiotic protocols for dental implant surgery on peri-implant tissue health and on oral microbiome and resistome
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Mean bone loss
研究概览
简要总结
The aim of the study is to evaluate if the short-span antibiotic therapy with amoxicillin per os is not inferior compared to the long-span antibiotic prescription in favouring peri-implant tissue healing (i.e. less peri-implant bone loss), while at the same time reducing the risk of developing antimicrobial resistance.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Patients requiring one single implant or partial implant-supported rehabilitation in an edentulous area of the posterior mandible or maxilla
排除标准
- •Patients unable to commit to follow-up - General contraindications to implant surgery - Immuno-suppressed/immune-compromised patients - Patients irradiated in the head and/or neck - Uncontrolled diabetes - Pregnancy, childbearing potential, breastfeeding - Smoking habit - Untreated periodontal disease (Caton et al, J Clin Periodontol 2018) - Poor oral hygiene and motivation (plaque index > 20%) - Addiction to alcohol or drugs - Psychiatric problems and/or unrealistic expectations - Patients with an acute infection (abscess) or suppuration in the site intended for implant placement - Patients treated or under treatment with intravenous amino-bisphosphonates - Patients referred only for implant placement if the follow-up cannot be done at the treatment center - Patients participating in other studies, if the present protocol could not be fully adhered to - Patients with allergy/hypersensitivity to penicillin or drug excipients - Patients recently treated with antibiotics for other indications
结局指标
主要结局
Mean bone loss
Mean bone loss
次要结局
- - Incidence of biological and technical complications - Implant survival rate (CSR) - Antibiotic sensitivity 1 week before and 2-6 months after implant insertion - Peri-implant myco-, microbiome and resistome 1 week before and 2-6 months after implant insertion - Salivary miRNomics 1 week before and 2 months after implant insertion - Adverse reactions - Development of a 3D bone model (sub-study) - Plaque index (PI), Bleeding on probing (BOP) and probing depth (PPD) a at 3, 6 and 12 months
研究者
Maria Menini
Scientific
Universita Degli Studi Di Genova
研究点 (1)
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