Remineralization Potential of Pearl Powder Compared to CPP-ACP on Enamel White Spot Lesions (Randomized Controlled Trial)
试验速览
- 阶段
- 2 期
- 入组人数
- 62
- 主要终点
- Clinical index used for visual evaluation of white spot lesions
研究概览
简要总结
The aim of this study is to evaluate the remineralization potential of pearl powder on early ('white spot') lesions in enamel in orthodontic patients compared to casein phosphopeptide-amorphous calcium phosphate.
详细描述
The aim of this study is to evaluate the remineralization potential of pearl powder on early ('white spot') lesions in enamel in orthodontic patients compared to casein phosphopeptide-amorphous calcium phosphate. The remineralisation potential will be assessed both visually and by standardised photographic image analysis. the follow up will be up to 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females.
- •Age: 12-25 years old.
- •Patients with good oral hygiene.
- •Co-operative patients who show interest to participate in the study.
排除标准
- •Patients with bad oral hygiene.
- •Lack of patient's approval and compliance.
- •Presence of abnormal oral, medical, or mental condition.
- •Patients who are allergic to milk products.
- •Pregnant and lactating women.
研究组 & 干预措施
Cpp-acp
MI paste Self-administration of the product by the patient once in the evening. A pea-size amount of the product should be applied per arch, using a dry finger or cotton pellet to distribute it evenly across all teeth and to work it into the interdental spaces. The product was then retained in the mouth for 1-3 min, and manipulated around the teeth using the tongue, before being expectorated and patient should not rinse it until 30 min.
干预措施: Cpp-Acp (Drug)
Pearl powder
Pure pearl powder in the form of gel Self-administration of the product should be used once daily (in the evening), after a 2 min manual tooth brushing. .Participants were explicitly instructed to apply the gel by his finger allover the teeth and not to rinse their mouths after application and not to eat or drink for at least 30 min.
干预措施: Pearl powder (Other)
结局指标
主要结局
Clinical index used for visual evaluation of white spot lesions
时间窗: 12 months
Scores(0-No visible colour change, 1-Slight white colour change, only visible after air-drying, 2-Slight colour change with certain marked white areas, 3-White consistent colour change, 4-Distinct white colour change)
次要结局
- Digital photographic image analysis(12 months)
研究者
Shereen Assem El-Sherif
Assistant Lecturer - Conservative Department- Faculty of Dentistry - MSA University
Cairo University