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临床试验/NCT03711097
NCT03711097撤回4 期

The Effectiveness of Resin-Modified Glass Ionomer Varnish in Preventing White Spot Lesions During Fixed Appliance Orthodontic Therapy

University of Nebraska0 个研究点开始时间: 2018年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
撤回
主要终点
Development of White Spot Lesion on the Labial Surface of the Upper Central and/or Lateral Incisors

研究概览

简要总结

This is a prospective study to determine the effects of resin-modified glass ionomer (RMGI) on the prevention of white spot lesion (WSL) development during fixed appliance orthodontic treatment. WSLs are the beginning stages of cavity formation on teeth and RMGI is a preventative material placed on teeth. The RMGI will be applied at the initial bonding appointment when braces are put on. RMGI will be applied to some participant's teeth while others will not receive the varnish treatment. Patients will be given standardized oral hygiene instructions. At six months, the RMGI will be reapplied to the same teeth that received the original RMGI application. The development of WSLs will be assessed both by photographs and visual assessment as well as utilizing laser technology to assess the level of enamel demineralization via a dental scanner called the Canary System. Participants will be examined at 3-month intervals for a total of nine months to one year to determine if application of RMGI during fixed appliance orthodontic therapy is effective in preventing the development of WSLs.

详细描述

This study is a prospective study to assess the effects of resin-modified glass ionomer (RMGI) on the prevention of white spot lesion (WSL) development during fixed appliance orthodontic treatment. WSLs are the beginning stages of cavity formation on teeth and RMGI is a material that is placed on the teeth to prevent WSLs. Patients will be recruited from the UNMC College of Dentistry Orthodontic Clinic who have been treatment planned to undergo fixed appliance therapy to include the maxillary central and lateral and central incisor teeth, which are the upper front four teeth in the mouth. In order to be included in this study, these teeth need to be fully erupted and planned to have braces on their front surfaces for a minimum of six months. The RMGI will be applied at the initial bonding appointment, which is the appointment that the subject receives their braces, to the labial surfaces of the teeth either to the right or left side central and lateral incisor. The control teeth will be the upper central and lateral incisors that do not receive the varnish treatment. Assignment of the left or right side will be randomized to obtain equal numbers of left and right-sided RMGI applications, mitigating the potential effects related to the handedness of the patients. The patients will be given standardized oral hygiene instructions and will be seen in follow up at 3-month intervals. At the 6-month mark, the RMGI will be reapplied to the same teeth that received the original RMGI application. At the initial bonding appointment and at each 3-month interval following, the development of WSLs will be assessed both by photographs and visual assessment as well as utilizing laser technology to assess the level of enamel demineralization via a dental scanner called the Canary System. Measurements and application of the RMGI will be performed by an individual examiner and a random subset of measurements will be re-measured after adequate washout time to ensure high intra-examiner reliability. Photographs will be assessed by examiners that have been blinded to the teeth receiving treatment. The goal of this study is to have the patients examined at 3-month intervals for a total treatment time of nine months to one year to ascertain if application of RMGI to the labial surfaces of the central and lateral incisor teeth during fixed appliance orthodontic therapy is effective in preventing the development of WSLs.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
10 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Willingness to participate in research project
  • Age ≥ 10 years old, fully erupted maxillary central and lateral incisors
  • treatment time with fixed appliances estimated to be at least 6 months

排除标准

  • Presence of peg lateral maxillary incisors
  • Presence of one or more significant WSLs on maxillary incisors prior to orthodontic therapy
  • Restorations covering a significant portion of the labial surfaces of the maxillary incisors
  • Unerupted maxillary incisors, presence of uncontrolled caries
  • Craniofacial Syndromic patients and patients with cleft lip and/or palate
  • Pregnant or breast-feeding patients

研究组 & 干预措施

Varnish Intervention

Experimental

Upper central and lateral incisor contralateral to control upper central and lateral incisor

干预措施: Vanish XT Dental Varnish (Drug)

结局指标

主要结局

Development of White Spot Lesion on the Labial Surface of the Upper Central and/or Lateral Incisors

时间窗: 6-9 months

The development of white spot lesion in subjects will be determined by photographs that are evaluated for white spot lesions by experienced orthodontists as well as by objectively measuring the level of demineralization of the teeth based on dental scanning technology (The Canary System). The Canary System gives a numerical score based on the level of demineralization of the tooth and indicates if demineralization is progressing or improving over time.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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