A randomized double-blind, parallel, clinical trial evaluating the efficacy of dissolving xylitol chewable tablets versus xylitol chewing gum on bacterial count, plaque accumulation and gingival inflammation in senior citizens.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Bacterial count,Plaque accumulation, Gingival inflammation
研究概览
简要总结
This randomized, double-blind, parallel-group clinical trial aims to evaluate and compare the efficacy of dissolving xylitol chewable tablets and chewing gum on salivary bacterial count, plaque accumulation, and gingival inflammation in senior citizens. 96 participants aged 60 years and above will be enrolled and randomly assigned to one of two intervention groups. Clinical parameters will be recorded at baseline and after 30 days of intervention.
This study aims to evaluate the efficacy of dissolving xylitol chewable tablets compared to xylitol chewing gum as a substitute for toothbrushing and mouth rinsing in countering bacterial levels, plaque formation, and gingival inflammation in elderly people.
The null hypothesis is that the xylitol-dissolving chewable tablets and xylitol chewing gum are equally effective on salivary Streptococcus mutans bacterial count, plaque formation, and gingival inflammation among senior citizens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 60.00 Year(s) 至 74.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion criteria involved at least 20 natural teeth and mild to moderate gingival inflammation.
排除标准
- •Subjects with systemic illness impacting oral health, history of known allergy to xylitol, or intake of antibiotics or antimicrobial mouthwashes over the last three months were excluded.
结局指标
主要结局
Bacterial count,Plaque accumulation, Gingival inflammation
时间窗: 0-30 days
次要结局
- salivary pH or flow rate(0-30 days)