The Effectiveness of Casein Phosphopeptide Amorphous Calcium Phosphate (MI Varnish) and 5% Sodium Fluoride Plus Xylitol (PreviDent Varnish) on Non Cavitated Interproximal Lesions. Randomised Clinical Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Radiographic outcome
研究概览
简要总结
Fluoride products are proven to be cost effective in preventing dental caries. Newer Fluoride products have been released in the market with different components that may have an impact on the clinical and radiographic outcome regarding incipient caries management. The objective of the study is to compare the effectiveness of PreviDent and MI varnish to (1.23%) Acidulated phosphopeptide Fluoride (APF) on remineralisation of non-cavitated proximal incipient lesions.
详细描述
The patients will be randomly assigned in three groups by coin toss after obtaining the consent form and filling the questionnaire about file number, gender, socioeconomic status, education and occupation of the parents and their marital status. Group one will receive MI varnish, group two will receive PreviDent varnish, group three will receive 1.23% APF standard Fluoride application. The teeth will be cleaned, plaque will be removed, placement of wedge/separator and teeth will be dried with the aids of light, mouth mirror and dental probe followingInternational Caries Detection and Assessment System (ICDAS) score. The clinical assessment will be conduct during the application visit initial (T1), three months follow up visit (T2) six months follow up visit (T3) and twelve months follow up visit (T3) to evaluate the effectiveness of the different types of Fluoride. The radiographic assessment will be conducted during (T3) and (T4).
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is 7-10 mixed dentition
- •Patients with any incipient non cavitated posterior proximal caries
- •Patients with any incipient non cavitated anterior proximal cariesanterior
- •ICDAS Score 1 or 2
排除标准
- •Any patients with any serious chronic medical problem.
- •caries that cross the dentin-enamel junction (DEJ) or enamel discontinuity
- •history of proximal restorations
- •history of resin infiltrate
- •ICDAS score of proximal caries more than two clinically or radiographically.
研究组 & 干预措施
PreviDent Varnish Group
The teeth will be cleaned, plaque will be removed, placement of wedge/separator and teeth will be dried with the aids of light, mouth mirror and dental probe following ICDAS score. Group two will receive PreviDent varnish according to the manufacture instructions in the first visit and each follow up visits.
干预措施: PreviDent Varnish (Drug)
MI Varnish Group
The teeth will be cleaned, plaque will be removed, placement of wedge/separator and teeth will be dried with the aids of light, mouth mirror and dental probe following ICDAS score. Remineralization protocol, group one will be treated with MI varnish according to the manufacture instructions in first visit and each follow up visits.
干预措施: MI Varnish (Drug)
1.23% APF Control Group
Regular application of APF for 4 minutes with high volume suction to the whole mouth.
干预措施: 1.23% APF (Drug)
结局指标
主要结局
Radiographic outcome
时间窗: 1 year
Incipient lesions either remained the same or worsened.
次要结局
- Clinical examination(1 year)
研究者
Narmin Helal
Assistant Professor
King Abdulaziz University