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临床试验/DRKS00012540
DRKS00012540已完成未知

Efficacy of Fluor-Protector S fluoride varnish for preventing white-spot lesions and gingivitis in fixed orthodontic treatment of patients with high risk of caries - a randomized controlled trial

Poliklinik für Kieferorthopädie,Universitätsklinikum Regensburg0 个研究点目标入组 44 人开始时间: 2017年6月8日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
44

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized controlled study
盲法
Blinded (masking used)

入排标准

年龄范围
one 至 18 Years(—)
性别
All

入选标准

  • Patients before starting a fixed orthodontic therapy in buccal technique (in both dental arches) with a minimum expected treatment period of 6 months
  • Bonding of brackets in the upper and lower arch on the same day (T0)
  • no previous or paused fixed orthodontic therapy
  • all permanent incisors, canines and premolars in both arches are present or erupted (5-5)
  • All anterior teeth and premolars in both arches are intended to be fit with a bracket (20 tooth surfaces / participant).

排除标准

  • Patients = 18 years (adults)
  • Pregnancy or lactation
  • Application of a dental fluoride varnish or other caries-protective varnish preparations within the last 12 months
  • Patients with a low to moderate caries risk (corresponding to 4 assessment parameters)
  • Enamel changes (fluorosis, hypocalcification, etc.)
  • Fillings and restorations in buccal tooth surfaces (with bracket)
  • Syndrome patients and patients with reduced oral hygiene ability or ability to perform the study properly
  • systemic, endocrine or oral diseases (diabetes, periodontitis, open oral wounds / ulcers, etc.), poor general condition
  • alcohol / drug abuse, smoking (tobacco), long-term medications or antibiotics / antisialoga / steroids or other medicines affecting the saliva, biofilm or the tooth holding apparatus in the last 6 months
  • local fluoride content in domestic drinking water> 0.2ppm F-
  • Allergy / intolerance to fluorides or the preparations used
  • Missing written consent
  • Patients who are not prepared to comply with the protocol (no additional fluoride / PZR, dental treatment in consultation with orthodontists, oral hygiene, etc.)

研究者

发起方
Poliklinik für Kieferorthopädie,Universitätsklinikum Regensburg

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