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临床试验/NCT02896556
NCT02896556已完成不适用

Evaluation of Esthetic Performance of Resin Infiltration Technique on Hypomineralized and Demineralized Enamel Lesions

Hacettepe University2 个研究点 分布在 2 个国家目标入组 33 人开始时间: 2017年8月31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
33
试验地点
2
主要终点
Esthetic success of resin-infiltration technique after 6 months as assessed by spectrophotometry

研究概览

简要总结

The purpose of this study is to evaluate the esthetic performance of resin infiltration technique on superficial hypo-mineralized and demineralized enamel lesions of anterior teeth

详细描述

The teeth that meet the inclusion criteria will be cleaned from debris and clinical intra-oral photos of the lesions will be taken before and after the treatment. Resin infiltration technique will be performed according to manufacturer's instructions under rubber-dam isolation. Intra-oral photos will be taken directly after infiltration (1 day), and 1 week and 6 months later.

The system of the Commission Internationale de l'Eclairage (CIE) involving 3 color parameters: lightness (L), red/ green chromaticity (a), and yellow/blue chromaticity (b), will be used to assess the extent and durability of color and lightness changes between lesion and sound enamel areas before and after resin infiltration. The extent of assimilation and durability of effect will be assessed by comparing CIE L*a*b data collected before infiltration (baseline), directly after infiltration (1 day), and 1 week and 6 months later.

The color assessments were standardized using a spectrophotometer (SpectroShade, Italy). Lesion areas will be measured for each time point by using an image analysis toolkit (ImageJ, National Institutes of Health, Bethesda, Md.).

Multifactorial analysis of variance with repeated measures will be used for statistical analyses.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
7 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients and parents of patients who accept to participate and sign the informed consent.
  • At least one non-cavitated anterior teeth with a superficial discoloration on enamel due to demineralization or hypo mineralization
  • Fully erupted anterior teeth with closed apices.

排除标准

  • Patients and parents of patients who accept to participate.
  • Teeth having absence of active cavitated-caries lesions, root canal treatment or restorations
  • Teeth with ICDAS code 3 lesions (localized enamel breakdown due to caries with no visible dentin)
  • Teeth that have a previously esthetic procedure (e.g. bleaching)
  • Patients who are not in cooperation with the procedure.
  • Fully erupted teeth with open apices

结局指标

主要结局

Esthetic success of resin-infiltration technique after 6 months as assessed by spectrophotometry

时间窗: 6 months

次要结局

未报告次要终点

研究者

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

Zafer Cavit Cehreli, DDS, PhD

Professor

Hacettepe University

研究点 (2)

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