The Impact of Amoxicillin Use on the Stability of the Oral Microbiome in Systemically Healthy Cohorts Undergoing Tooth Extractions - A Prospective Clinical Study
试验速览
- 阶段
- 不适用
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Microbiome shift
研究概览
简要总结
This is a prospective, longitudinal, observational, cohort study investigating young adults undergoing surgical extraction of a wisdom tooth with and without antibiotics post-operatively. The prescription of antibiotics will be based on clinical judgment based on case complexity, trauma and length of procedure. No randomization will be performed. Saliva will be collected at seven observational time points ( Baseline, one week ,two weeks, three weeks , one month,three months and six months.) and Supragingival plaque samples will be collected at four observational time points ( Baseline , one week , one month, and 3 months) .A control group of 15 subjects who do not undergo dental extractions or antibiotic treatment will be recruited after obtaining informed consent and will be followed up for the same seven time points..Routine standard care will be observed. No new medications are triedThe samples will be analysed for identification of bacterial genes using 16 S r RNA gene sequecing and QPCR for change in the antibiotic resistance genes overtime. Kindly note that in the current study the participants are patients who are already scheduled to undergo tooth extractions with or without antibiotic treatment based on clinical judgement by the clinician performing the extraction. ( These patients are on the waiting list for third molar extractions in the dental hospital concerned.)
The participants will receive the intervention( Third molar extraction with /without antibiotics) in the same manner and intensity even if they are not enrolled for the study.
详细描述
Hypothesis A course of amoxicillin (250 mg ,three times daily for five days), routinely prescribed as a part of treatment protocol for third molar extractions causes a significant shift of the stable oral microbiome .
The primary outcome measures are to assess:
- Relative abundance of different bacteria at 5 specified time points assessed by 16 s r DNA gene sequencing of the oral microbiome.
- Relative abundance and expression of known antibiotic resistance genes assessed by a microarray of known resistant genes and functional metagenomics.
Secondary outcome measures are to assess the:
- Presence of inflammation in the oral cavity by measuring the levels of C- reactive protein in the saliva at 2 time points.
- Clinical signs and symptoms before and during the first week after treatment to monitor the presence of inflammation and infection.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women aged between 18 and 45 years
- •Subjects who are scheduled to have a surgical tooth extraction.
- •Subjects who have signed an informed consent after being informed of the study design, objectives and, risks/benefits
- •No history of use of antibiotics up to three months prior to participation in the study.
- •No medical condition that prevents the surgical procedure or antibiotic therapy.
- •No history of hypersensitivity to beta lactams.
- •No contraindication to amoxicillin therapy.
- •Subjects are not pregnant or currently breast feeding.
- •No known or suspected immunodeficiency.
- •9 EXCLUSION CRITERIA
- •History of antibiotic use within 3 months from baseline evaluation.
- •Any medical condition that prevents the surgical procedure or antibiotic therapy.
- •History of hypersensitivity to beta lactams
- •Contraindication for amoxicillin therapy
- •Pregnant or breast feeding women.
- •Subjects with known or suspected immunodeficiency.
- •Caries active subjects defined as subjects with active caries involving more than 3 teeth.
- •Subjects diagnosed with chronic periodontitis.
- •Subjects regularly using an antibacterial mouth rinse or planning to use one after the extraction.
排除标准
- 未提供
结局指标
主要结局
Microbiome shift
时间窗: Baseline - Six months
次要结局
- levels of c reactive protein(Baseline - One Month)
- Antibiotic resistance genes count(Baseline - One Month)
研究者
Dr Michael G. Botelho
Clinical Associate Professor
The University of Hong Kong