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临床试验/NCT07691879
NCT07691879尚未招募不适用

The Potential of Fluoride Sealants in Preventing White Spot Lesions During Orthodontic Treatment

Sigmund Freud PrivatUniversitat0 个研究点目标入组 40 人开始时间: 2026年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
主要终点
Prevalence of white spot lesions

研究概览

简要总结

The aim of this trial is to investigate the potential of using an adhesive bonding agent that also acts as a fluoride sealant when placing fixed orthodontic appliances in adolescent patients, as an alternative to regular bonding agents.

The main question it aims to answer is:

- Does an adhesive fluoride sealant reduce the prevalence of white spot lesions in orthodontic adolescent patients after an observation period of 3 months?

Participants who need orthodontic treatment and who agree to take part in this study will have their orthodontic appliance placed using regular adhesive on one side of their upper jaw and fluoride sealant on the other.

White spot lesion prevalence will be assessed using the Enamel Decalcification Index (EDI) at baseline and after 3 months.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
10 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age between 10 and 17 years
  • Initiation of fixed orthodontic treatment in the upper jaw
  • Presence of all teeth 15-25
  • Written consent from patients and legal guardians

排除标准

  • Pre-existing white spot lesions
  • Active carious lesions
  • Structural enamel defects
  • Systemic diseases affecting oral health
  • Vestibular restorations in the anterior region
  • Little Index > 9

结局指标

主要结局

Prevalence of white spot lesions

时间窗: 3 months

次要结局

  • Enamel Decalcification Index (EDI)(3 months)

研究者

发起方
Sigmund Freud PrivatUniversitat
申办方类型
Other
责任方
Sponsor

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