Effect of a Daily Dose of Snacks Containing Mannitol or Stevia Rebaudiana as Sweeteners in High Caries Risk Schoolchildren
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 271
- 试验地点
- 1
- 主要终点
- Caries risk reduction
研究概览
简要总结
This double-blind RCT aimed to evaluate the effect of sugar-free snacks on caries risk in 6-9 years-old schoolchildren. Considering a 20% difference among groups, the number of subjects needed per group was set in 87. Two-hundred-seventy-one children at risk for caries measured through Cariogram were selected and randomly assigned to three groups consuming twice a day snacks containing Stevia or Maltitol or sugar for 42 days. Parents filled out a standardized questionnaire regarding personal, medical and oral behavioural information. Bleeding on probing, plaque pH and cariogenic microflora were assessed at baseline (t0), after 21 (t1) and 42 days of snacks' use (t2) and 120 days after the end of use (t3). Cariogram was also repeated at t2.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •more than 1 initial carious lesion in the enamel (ICDAS 2-3),
- •but no manifest lesion in the dentine,
- •a salivary MS concentration ≥10^5 CFU/ml.
排除标准
- •Subjects with a history of systemic diseases and antibiotic therapy within 30 days before baseline were excluded.
研究组 & 干预措施
Stevia snacks
Children were instructed to use the snack twice a day, one in the morning and one in the afternoon during lesson breaks.
干预措施: delivery of snacks (Dietary Supplement)
Maltitol snacks
Children were instructed to use the snack twice a day, one in the morning and one in the afternoon during lesson breaks.
干预措施: delivery of snacks (Dietary Supplement)
Sugared snacks
Children were instructed to use the snack twice a day, one in the morning and one in the afternoon during lesson breaks.
干预措施: delivery of snacks (Dietary Supplement)
结局指标
主要结局
Caries risk reduction
时间窗: 42 days
calculation of the carie risk reduct using a standardised method aka "Cariogram"
reduction of salivary cariogenic bacteria
时间窗: 42 days
reduction of salivary cariogenic bacteria of one level eg from 1000000 to 10000 CFU/ml
次要结局
- modification of the plaque-pH(42 days)
研究者
Guglielmo Campus
Associate Professor of Community Dentistry and Oral Epidemiology
Università degli Studi di Sassari