Study Protocol for 16S rRNA Sequencing of Healthy Oral Microbiota
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Change in Salivary Microbial Alpha Diversity (Shannon and Simpson Indices)
研究概览
简要总结
This study evaluated the ecological effects of 0.06% chlorhexidine toothpaste on the salivary microbiota of healthy individuals, focusing on taxonomic composition, functional shifts, and prevalence of predicted antimicrobial resistance genes. Saliva samples were collected from eleven healthy participants at three specific time points: baseline (following a 4-week run-in period using a control toothpaste), intervention (after 12 weeks of using 0.06% chlorhexidine digluconate toothpaste), and washout (after a subsequent 12-week period using the control toothpaste). Sequencing targeted the 16S rRNA V3-V4 region.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 44 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: Between 25-44 years.
- •General Health: Good systemic health (absence of chronic inflammatory diseases or conditions affecting oral tissues).
- •Oral Hygiene Routine: Participants must perform toothbrushing twice a day and use interdental cleaning aids once a day.
- •Plaque Index (PI): A score of 0.0-0.2 according to Silness and Löe.
- •Gingival Index (GI): A score of 0.0-0.143 according to Silness and Löe.
排除标准
- •Systemic and Lifestyle Factors:
- •Presence of any chronic systemic disease (e.g., diabetes mellitus, autoimmune disorders)
- •Regular use of medications that may affect gingival status or saliva production.
- •Use of antibiotics within the last 6 months prior to the study.
- •Current pregnancy or lactation.
- •Current smokers or users of other tobacco/nicotine products.
- •Oral and Dental Factors:
- •Active dental disease: Presence of untreated tooth decay, gingivitis (GI > 0.143), or any form of periodontitis.
- •Prosthetics and Implants: Presence of dental implants, dentures, or significant tooth loss (excluding extracted third molars).
- •Ongoing fixed or removable orthodontic treatment.
研究组 & 干预措施
Experimental: Chlorhexidine group
A single group of 11 healthy volunteers. The study consists of three consecutive phases: baseline (4 weeks), intervention with 0.06% chlorhexidine toothpaste (12 weeks), and washout (12 weeks).
干预措施: 0.06% Chlorhexidine Digluconate Toothpaste (Drug)
结局指标
主要结局
Change in Salivary Microbial Alpha Diversity (Shannon and Simpson Indices)
时间窗: Baseline (week 0), after intervention (week 12), and after washout (week 24).
Evaluation of microbial richness and evenness within individual saliva samples. Alpha diversity is quantified using the Shannon and Simpson indices based on 16S rRNA gene sequencing data. Differences between study phases (baseline, intervention, washout) are assessed using the Kruskal-Wallis test or Mann-Whitney U test, as appropriate, with a significance threshold of p \< 0.05.
Change in Salivary Microbial Beta Diversity (Community Structure)
时间窗: Baseline (week 0), after intervention (week 12), and after washout (week 24).
Evaluation of differences in microbial community composition between study phases. Calculated using Bray-Curtis dissimilarity on Centered Log-Ratio (CLR) normalized data and assessed via PERMANOVA to detect significant shifts (p \< 0.05).
次要结局
- Differential Abundance of Salivary Bacterial Taxa(Baseline (week 0), after intervention (week 12), and after washout (week 24).)
- Changes in Predicted Antimicrobial Resistance Genes (ARGs)(Baseline (week 0), after intervention (week 12), and after washout (week 24).)
- Gingival Index (GI) for Clinical Stability Assessment(Screening (Week -4) and after washout (Week 24).)
- Plaque Index (PI) for Clinical Stability Assessment(Screening (Week -4) and after washout (Week 24).)