NCT02468388已完成不适用
Study on the Effect of Chewing Sugar-free Gum on Re-mineralization of Early Caries Via Quantitative Light-induced Fluorescence
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 482
- 试验地点
- 1
- 主要终点
- Change from baseline in re-mineralization of early caries at 3 months measured by quantitative light-induced fluorescence
研究概览
简要总结
The purpose of this study is to evaluate the clinical effect of chewing gum containing maltitol, on re-mineralization of early caries following daily chewing for 6 months by school children, compared to a xylitol gum, gum base and a no gum group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 8 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consent Informed Consent Form signed by parent or legal guardian permitting participation of their children.
- •Be cooperative and able to be examined in the whole study duration.
- •Aged from 8 to 13 years.
- •General Health: Good general health (in the opinion of the investigator) without clinically significant and relevant abnormalities of medical history such as diabetic, etc.
- •Oral Health: Display 6 permanent front teeth and two maxillary buccal surfaces with visual evidence of active initial enamel carious lesions (de-mineralized but not cavitated); No any form of intraoral prostheses or appliances, clinical signs of severe gingivitis or periodontitis, temporomandibular joint disorders, and malocclusions or chronic onychophagia
- •Oral Hygiene: have good oral health habits, brushing teeth at least once per day
- •No medical or pharmacotherapy history that might affect the outcomes of the study, e.g. use of mouthwash, gels, or chewing gum containing antimicrobial agents during the previous 3 months
排除标准
- •Disease: Presence of chronic debilitating disease, or any condition or other chronic disease which the investigators think not suitable for the study.
- •Allergy/Intolerance: Be allergic to both maltitol and xylitol, oral care products, personal care consumer products, or their ingredients.
- •Current Product Use: usual chewing-gum (of any kind) consumer or sugars-free candies consumer
- •Clinical Study/Experiment: Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
结局指标
主要结局
Change from baseline in re-mineralization of early caries at 3 months measured by quantitative light-induced fluorescence
时间窗: baseline and 3 months
Change from baseline in re-mineralization of early caries at 6 months measured by quantitative light-induced fluorescence
时间窗: baseline and 6 months
次要结局
- Change from baseline in Streptococcus mutans counts in saliva at 3 months measured by Dentocult strip(baseline and 3 months)
- Change from baseline in Streptococcus mutans counts in saliva at 6 months measured by Dentocult strip(baseline and 6 months)
- Change from baseline in Potential hydrogen (pH) of saliva at 3 months measured by pH meter(baseline and 3 months)
- Change from baseline in Potential hydrogen (pH) of saliva at 6 months measured by pH meter(baseline and 6 months)
- Change from baseline in Silness & Loe Plaque index at 3 months(baseline and 3 months)
- Change from baseline in Silness & Loe Plaque index at 6 months(baseline and 6 months)
研究者
研究点 (1)
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