Impact of Non-surgical Periodontal Therapy With or Without Antibiotics on Oral and Gut Microbiome in Patients With Stage III/IV and Grade C Periodontitis
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in the oral-gut axis microbiome at 3 months
研究概览
简要总结
Periodontitis is an inflammatory disease characterized by a dysbiotic microbiome which can lead to bone destruction and tooth loss. Several studies had been reported the association to periodontal disease with systemic conditions and this relation suggests and axis that links oral and gut microbiome. In order to clarify the impact of periodontal condition on gut microbiome, we aim to evaluate the clinical, immunological parameters and the microbiological condition by sequencing of subgingival biofilm and stool samples both before and after non-surgical periodontal treatment with and without antibiotics as adjunct.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Stage III/IV and grade C Periodontitis
- •Presence of at least 20 teeth
- •Good general health
排除标准
- •Pregnant or lactating
- •Were suffering from any other systemic diseases (e.g., cardiovascular, diabetes)
- •Received antimicrobials in the previous 6 months
- •Received a course of periodontal treatment within the last 6 months
- •Were taking long-term anti-inflammatory drugs
- •Smoking habits
研究组 & 干预措施
FMUD + Placebos
One session of full-mouth ultrasonic debridement (FMUD) with a time limit of 45 minutes plus placebo administration prescribed on the day of treatment, every 8 hours for 7 days.
干预措施: One-Stage Full Mouth Debridement (Procedure)
FMUD + Placebos
One session of full-mouth ultrasonic debridement (FMUD) with a time limit of 45 minutes plus placebo administration prescribed on the day of treatment, every 8 hours for 7 days.
干预措施: Amoxicillin Placebo (Drug)
FMUD + Placebos
One session of full-mouth ultrasonic debridement (FMUD) with a time limit of 45 minutes plus placebo administration prescribed on the day of treatment, every 8 hours for 7 days.
干预措施: Metronidazole Placebo (Drug)
FMUD + AM
One session of full-mouth ultrasonic debridement (FMUD) with a time limit of 45 minutes plus 500 mg Amoxicillin and 250 mg Metronidazole (AM) prescribed on the day of treatment, every 8 hours for 7 days.
干预措施: One-Stage Full Mouth Debridement (Procedure)
FMUD + AM
One session of full-mouth ultrasonic debridement (FMUD) with a time limit of 45 minutes plus 500 mg Amoxicillin and 250 mg Metronidazole (AM) prescribed on the day of treatment, every 8 hours for 7 days.
干预措施: Amoxicillin 500mg (Drug)
FMUD + AM
One session of full-mouth ultrasonic debridement (FMUD) with a time limit of 45 minutes plus 500 mg Amoxicillin and 250 mg Metronidazole (AM) prescribed on the day of treatment, every 8 hours for 7 days.
干预措施: Metronidazole 400mg (Drug)
结局指标
主要结局
Change in the oral-gut axis microbiome at 3 months
时间窗: Baseline and 90 days
Concentration of bacteria in the subgingival biofilm and stool samples
次要结局
- Change of the baseline relative clinical attachment level at 3 months(Baseline, 30 days and 90 days)
- Change of biofilm gene expression on oral microbiome at 3 months(Baseline and 90 days)
- Change of the baseline inflammatory markers levels in gingival crevicular fluid (pg/uL) and stool samples(Baseline and 90 days)
研究者
Renato Casarin
Professor of Periodontics in Piracicaba Dental School-FOP/UNICAMP
University of Campinas, Brazil