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临床试验/NCT03426150
NCT03426150已完成4 期

In Situ Effect of Casein Phosphopeptide--amorphous Calcium Phosphate on the Surface Microhardness of Human Enamel Subjected to in Vivo Acid Attacks

Fujian Medical University0 个研究点目标入组 12 人开始时间: 2015年12月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
12
主要终点
Surface microhardness

研究概览

简要总结

40 specimens were prepared from fresh-extracted human molars and further embedded using the acrylic resin. Specimens were randomly divided into 2 groups according to the treatment before in vivo erosion (n=20): CPP-ACP for 3 min (CPP-ACP group) and deionized water for 3 min (control group). 10 healthy volunteers were recruited and customized maxillary appliance containing 4 specimens (2 from CPP-ACP group and 2 from control group) was fabricated for each volunteer. Participants were instructed to drink 150 ml cola in 5 min using the gargling method after placing appliances intraorally for 2 h. The in vivo attacks were performed 4 X 5 min with 1-h interval daily over 7 d. The surface microhardness and surface microstructure of the specimens were evaluated at the baseline and after the treatment. The data were statistically analyzed using three-way ANOVA and post hoc tests. Data were considered statistically significant at a level of P <0.05.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 18 to 60 years of age and in good general health
  • Dental erosion and wear degree is 0-1

排除标准

  • Systemic diseases or oral mucosal disorders
  • Current orthodontic treatment
  • Pregnancy
  • Known allergies to the experimental drink
  • Had been given drugs which lead to dry oral more regularly within half a year

研究组 & 干预措施

CPP-ACP

Experimental

Tooth mousse (GC, Japan) application on the specimen surface for 3 min.

干预措施: CPP-ACP (Drug)

Deionized water

Placebo Comparator

Deionized water application on the specimen surface for 3 min

干预措施: Placebos (Drug)

结局指标

主要结局

Surface microhardness

时间窗: 7 days

a Vickers microhardness tester with microscopic lens was used, with a 100 g load and 30-s dwell time. Three microhardness measurements were obtained on the top surface of each specimen.

次要结局

未报告次要终点

研究者

发起方
Fujian Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hao Yu

Department Head

Fujian Medical University

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