跳至主要内容
临床试验/NCT02925780
NCT02925780撤回不适用

In Vivo Action of Infiltrating Resin Icon® on Fluorosis - a 12 Month Follow up Trial

DMG Dental Material Gesellschaft mbH0 个研究点开始时间: 2019年12月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
action of DMG Icon-infiltrative ® resin and micro abrasion to mask fluorotic enamel

研究概览

简要总结

Clinical trial to investigate the clinical efficiency of resin infiltration compared to microabrasion in the improvement of dental fluorosis.

详细描述

Dental fluorosis is an endemic public health concern that develops if infants are subjected to excessive amounts of fluoride during enamel formation. Anatomopathologically, dental fluorosis presents itself as a hypermineralized surface layer and subsurface hypomineralization involving the external third of the thickness of the enamel, which is equivalent to early carious lesions. In addition, fluorosis features a number of clinical changes in the enamel surface, ranging from the appearance of thin white lines up to severe structural defects, thereby compromising overall esthetics, which sometimes leads to children dropping out of school due to its psychological impact.

The aim of this controlled clinical trial is to evaluate the efficacy of enamel microabrasion and resin infiltration in improving the dental esthetic of patients with fluorosis. Resin infiltration is a microinvasive technique that can improve the esthetics by infiltrating a low-viscosity resin (that has a similar refractive index to enamel) into the porose hypomineralized enamel of fluorosed white spots. This approach thus largely preserves the enamel compared to more invasive techniques such as microabrasion and has been shown to be efficient in previous studies.

This study will be conducted in the provinces of Pichincha and Cotopaxi, Ecuador and patients between 10 to 12 years of age with stage 1, 2, and 3 fluorosis according to the Thylstrup and Fejerskov (TF) scale or questionable, very mild, and mild fluorosis according to Dean's Index will be recruited. In addition to the immediate esthetic improvement, long term stability of the outcome will be assessed at 3, 6 and 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
10 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Questionable, Very mild, and Mild (Dean's Index) dental fluorosis as well as TF scale grades 1, 2, and 3 of the upper anterior teeth.
  • Parents of children who accept and commit to the informed consent letter collaborate with the study taking their children to each of the scheduled follow ups.

排除标准

  • Teeth without fluorosis.
  • Teeth with hypoplasia.
  • Teeth with incipient caries lesions observed at gingival level and differentiated by the Presence of plaque.
  • Teeth previously restored or with aesthetic corrective treatments
  • Teeth with endodontic treatment.
  • Patients with low or questionable hygiene.
  • Malnourished patients or that have some underlying disease.
  • Teeth with less than two thirds of its visible crown.
  • Children that have less than six teeth in their oral cavity.
  • Allergic reaction to methylmethacrylate.

结局指标

主要结局

action of DMG Icon-infiltrative ® resin and micro abrasion to mask fluorotic enamel

时间窗: immediate after treatment

Evaluate the action of DMG Icon-infiltrative resin and micro abrasion immediately after application to mask fluorotic teeth by comparison of pre- vs. post-treatment photographs

次要结局

  • Surface changes(12 month)
  • Clinical characteristics Icon(3, 6, 9, 12 month)
  • Efficacy of infiltration to mask fluorotic teeth long-time(12 month)

研究者

申办方类型
Industry
责任方
Sponsor

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