Fluoridated Milk is Effective in Prevention of Enamel Caries in Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 159
- 试验地点
- 1
- 主要终点
- Caries development in enamel and dentine
研究概览
简要总结
The goal of this trial is to investigate whether low daily doses of fluoridated milk, in addition to oral hygiene routines with fluoridated toothpaste, can prevent caries development in adolescents' teeth. The main questions it aims to answer are:
- Does fluoridated milk lower the number of caries lesions in teeth over time?
- Does fluoridated milk lower the number of enamel caries lesions over time? Researchers will compare an intervention group receiving doses of fluoride in water to add to milk and a control group receiving water to add to milk.
The 12-13 year participants will:
- be examined at a baseline and once yearly up to 2 years
- be provided directly with the doses every second month at their dental clinic
- take the fluid daily
详细描述
During the study, the participants were asked to continue with their usual oral hygiene regimes, including tooth-brushing twice a day with toothpaste containing fluorides as recommended by the Swedish National Board of Health and Welfare.
At their yearly visit to their dental clinic the participants were asked about their health status, use of antibiotics, lactose intolerance, daily consumption of milk, tooth brushing frequency, type of toothpaste and use of other fluoride additives. Information on adverse effects (dental pain, visit to other dental clinic, and antibiotics due to dental infection) was collected.
Caries registration was performed by visual-tactile and radiographic examinations at baseline and 1 and 2 years. Visual-tactile examination was performed by a dental practitioner under lighting with a mirror and occasionally with a probe. Caries status was classified for the occlusal/incisal, buccal and lingual surfaces and the proximal surfaces of incisors and cuspids according to the ICDAS criteria with code 0 (for sound), 1-3 (for enamel caries) and 4-6 (for dentine caries). ICDAS is an internationally applied system for caries detection used clinically (The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries (reference). Radiographic examination of the proximal surfaces of premolars and molars with one bitewing radiograph on each side of the mouth took place in the same session.
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)
盲法说明
The subjects and their parents/guardians, the clinicians performing the examinations, the staff-members delivering the packages with solutions to the subjects, the trial investigators and the outcome assessors were blind to the allocation and group assignment. The solutions were distributed to the subjects in tubes pre-labelled with code numbers. The tubes had the same design independent of the solution with fluoride or placebo.
After the randomization, lists with code numbers were saved as sealed files in a safety-deposit box. The code was broken when the study was completed, and the assessment of the outcome measures were processed.
入排标准
- 年龄范围
- 12 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •adolescents of both sexes, aged 12-¬13
- •healthy (no oral disease or systemic disease possibly affecting the oral cavity). Health declaration used in the dental clinic was utilized to confirm health status
- •adolescents with permanent posterior teeth/no primary molar teeth present and second premolars in contact with the mesial surface of the first molars
- •adolescents who, together with their parents or guardians, gave informed written consent to participate. Data confidentiality and the right to withdraw from the study at any time were warranted to the adolescents in writing.
排除标准
- 未提供
研究组 & 干预措施
Intervention
The subjects in the intervention group received individually packaged daily doses of sodium fluoride solution in 0.5 ml sterile water to be added to 200 ml of milk
干预措施: sodium sodium fluoride solution (0.75 mg for subjects aged 12 and 1.0 mg for subjects aged 13) (Dietary Supplement)
Control group
Subjects in the control group received a daily dose of 0.5 ml sterile water to be added to 200 ml of milk.
干预措施: Subjects in the control group received a daily dose of 0.5 ml sterile water to be added to 200 ml of milk. (Dietary Supplement)
结局指标
主要结局
Caries development in enamel and dentine
时间窗: From enrollment to the end of intervention at 2 years
caries increment measured as change/no change of DMFS (Decayed, Missing, Filled, Surfaces)
次要结局
- Caries lesion arrest(From enrollment to the end of intervention at 2 years)
- Caries lesion progression(From enrollment to the end of intervention at 2 years)
研究者
Gunnel Svensater
Professor
Malmö University