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临床试验/NCT05764187
NCT05764187已完成不适用

Incidence of White Spot Lesions Around Ceramic Brackets Compared With Metal Brackets Evaluated With Quantitative Light-induced Fluorescence: A Randomized Clinical Trial

Jordan University of Science and Technology2 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2021年12月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
2
主要终点
Lesion area

研究概览

简要总结

The main objective of this study was to investigate the relation between ceramic brackets and the development of white spot lesions (WSLs) compared to that associated with conventional metal brackets.

详细描述

Objectives : The main objective of this study was to investigate the relation between ceramic brackets and the development of WSL compared to that associated with conventional metal brackets.

Study design: Randomized 2-parallel arm clinical trial. Materials and methods: Quantitative light induced fluorescence (QLF) images were taken for the two randomly allocated groups (Ceramic group, n=26; Metal group, n=25) of patients at T0: before the start of treatment; T1: after 2 months and T2: at 4 months after treatment). The QLF images were analyzed; Primary outcome measures: The lesion area (Pixels) and Mean amount of fluorescence loss (∆F)% and the number of newly developed lesions. Secondary outcome: Maximum fluorescence loss (∆F-Max)% and plaque surface area (∆R 30)%. Means and standard deviations for all the measured parameters at T0, T1 and T2 were calculated. Split plot analysis of variance (SPANOVA) test was used to determine the changes within each group at the different time intervals, and between the two groups. Chi square was used to compare between the two groups regarding the number of new lesions during the treatment. P value was set at 0.05 level.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

盲法说明

It was not possible to mask nether the participants nor the care provider

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy subjects seeking orthodontic treatment with mild-to-moderate crowding (not exceeding 5 mm)
  • No previous orthodontic treatment
  • Optimum oral hygiene
  • Maximum of 3 restored teeth
  • Absence of defective enamel formation in the form of hypocalcification or hypoplasia.

排除标准

  • Subjects with poor oral hygiene
  • Defective enamel
  • Patients with syndromes and Oro-facial anomalies or salivary glands diseases

结局指标

主要结局

Lesion area

时间窗: 4 months

Surface area of the lesion measured in Pixels

Incidence of white spot lesions

时间窗: 4 months

The number of newly developed white spot lesions

Maximum fluorescence loss ∆Fmax(%)

时间窗: 4 months

Deepest point of the lesion

Mean fluorescence loss ∆F(%)

时间窗: 4 months

Mean lesion fluorescence loss reflecting mineral loss measured in percent

次要结局

  • Plaque measurement(4 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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