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.)
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