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临床试验/NCT03187483
NCT03187483已完成不适用

Do Adhesive Flash-free Brackets Affect Bacterial Plaque? A Randomized Controlled Clinical and Microbiological Assessment

Ege University0 个研究点目标入组 45 人开始时间: 2014年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
45
主要终点
development of white spot lesion (WSL)

研究概览

简要总结

This study aimed to compare flash-free bracket system with conventional adhesive-coated bracket system in patients with maxillary crowding.

详细描述

Aim: The aim of this split-mouth study was to compare conventional and adhesive flash-free-bracket systems in terms of plaque retention, white spot lesion formation, biomarker levels and select microbes in gingival crevicular fluid (GCF).

Materials & Methods: Thirty-seven systemically healthy patients (18 males, 19 females) with the age range of 13-18 years were involved in this split-mouth study. Clinical evaluations, quantitative light-induced fluorescence (QLF) imaging, GCF and plaque samplings were performed at baseline and at 1-, 2-, 3-months. QLF was repeated following debonding, GCF samples were analyzed by immunoassay and real-time PCR for the biomarker and bacteria content. Data were analyzed by Wilcoxon on dependent samples.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

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

入选标准

  • being systemically healthy
  • having 4-7 mm maxillary crowding with a maximum of 2 mm linear displacement of contact points and non-extraction treatment planning.

排除标准

  • 未提供

研究组 & 干预措施

Flash-free bracket group

Active Comparator

Orthodontic treatment with flash-free bracket system

干预措施: orthodontic treatment (Procedure)

Control

Active Comparator

Orthodontic treatment with conventional adhesive-coated brackets

干预措施: orthodontic treatment (Procedure)

结局指标

主要结局

development of white spot lesion (WSL)

时间窗: 1 month

WSL is the first sign of caries

次要结局

  • plaque accumulation around the brackets(1 month)
  • microbial composition around the brackets(1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nurcan Buduneli

Professor

Ege University

相似试验

Flash-free Brackets and Dental Plaque | 临床试验