The Effect of Post-surgical Chlorhexidine Mouth Washing on the Sub-gingival Periodontal Microbiome; a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- alpha and beta diversity
研究概览
简要总结
Prospective applicants who conform with inclusion and exclusion criteria will be accepted into the study and sign a consent form.
Visit 1: After initial screening a case report form (CRF) will be filled, including information regarding general health, medication, demographic, oral and dental information. Participants will be clinically examined and the following data will be collected prior to surgery: microbial collection, Plaque score (PS) , probing pocket depth (PPD), bleeding on probing (BOP) at selected non-surgical and surgical teeth. Surgery will be performed followed by discharge with a bottle of chlorhexidine mouthwash and written instructions on its usage. Visit 2: Ten days after surgery sutures will be removed and collected for microbial examination. Microbial collection will be performed at non-surgical and surgical sites. Adverse events will be recorded and participants will be discharged from the study.
详细描述
Microbial identification: periodontal samples will be collected by the GeneFiX™ Saliva DNA Microbiome Collection Device (Isohelix). DNA Extraction - the MagMAX Microbiome Ultra Nucleic Acid Isolation Kits (Termo Fisher). DNA yields and purity - measuring absorbance at 260 nm, A260/A280 and A260/A230 ratios with the Nano-drop 2000 spectrophotometer (Nanodrop products, Wilmigton,USA). Microbiome sequencing - target V4 region of 16s rRNA gene will be sequenced on the Ion Torrent S5 instrument (Thermofisher) and analysis will be performed with the ERGO 2.0 platform ( iGenbio). The investigators will perform comparisons of alpha and beta diversity before and after intervention, as well as differential abundance of the taxa.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed Informed Consent Form
- •Age ≥18 years
- •Scheduled for periodontal/dental surgery without pre- and/or post-surgical antibiotic therapy
排除标准
- •Pre-existing conditions that may affect the microbiome, including diagnoses of diabetes, malignancy, alcoholism, previous head and neck radiation therapy
- •Pregnancy and breast-feeding
- •Chronic medications that are known to affect periodontal tissues such as Ca channel blockers and phenytoin
- •Antibiotic therapy within the previous 6 weeks
- •Mouthwash therapy within the previous 2 weeks
- •Known allergy to CM or any of its constituents
- •Smoking >10 cigarettes/day
结局指标
主要结局
alpha and beta diversity
时间窗: 10-14 days
sub-gingival microbiome changes between pre- and post- mouthwash usage in non-surgical sites and in surgical sites
次要结局
未报告次要终点
研究者
Jacob Horwitz MD
Director-Graduate Program in Periodontology
Rambam Health Care Campus