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临床试验/NCT04685889
NCT04685889已完成不适用

Clinical Evaluation of the Effect of Resin Infiltration Treatment on Hypomineralised Enamel Surfaces

Tokat Gaziosmanpasa University2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2018年5月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
34
试验地点
2
主要终点
Changes in the lesion colour

研究概览

简要总结

The investigators aimed to evaluate changes in mineralisation degree, colour, and size of the lesion after Icon® in permanent teeth with MIH in 6 months.

详细描述

A total of 116 permanent central teeth of 37 patients were included in the study. Icon® was applied to teeth with MIH, while the healthy teeth received no treatment (control).

Group I : Icon® resin infiltration treatment was performed on 58 permanent central teeth with MIH and evaluated before; immediately after; and 1, 3, and 6 months after the procedure.

Group II (Control Group): No treatment was performed on healthy teeth. However, similar to the treated teeth, 58 healthy permanent central teeth of the same individuals were evaluated before; immediately after; and 1, 3, and 6 months after the procedure.

Lesions were evaluated before, immediately after, and 1, 3, and 6 months after treatment. Mineralisation degree of MIH lesions was evaluated using DIAGNOdent Pen, changes in the lesion colour and lesion size were evaluated using VITA EasyShade and the cross polarization technique, respectively.

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
None

入排标准

年龄范围
8 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Molar incisor hypomineralisation on the labial surface of permanent central teeth Least one of the labial surface of the permanent anterior teeth were affected by MIH.

排除标准

  • Dental caries and filling on anterior teeth.
  • Dental anomaly on anterior teeth.
  • Undergoing orthodontic treatment.
  • Periodontal diseases.
  • Cognitive and behavioural problems.

结局指标

主要结局

Changes in the lesion colour

时间窗: Baseline (before resin infiltration), immediately after resin infiltration, 1 month later, 3 months later, 6 months later

Changes in the MIH lesions colour was evaluated using VITA EasyShade (Spectrophotometers are equipped with sensors that can measure in many wavelengths)

Changes in the Mineralisation degree

时间窗: Baseline (before resin infiltration), immediately after resin infiltration, 1 month later, 3 months later, 6 months later

MIH lesions was evaluated using DIAGNOdent Pen (laser fluorescence)

Lesion size evaluated using cross polarization technique

时间窗: Baseline (before resin infiltration), immediately after resin infiltration, 1 month later, 3 months later, 6 months later

Changes in the MIH lesions size was evaluated using cross polarization technique

次要结局

未报告次要终点

研究者

发起方
Tokat Gaziosmanpasa University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Halenur Altan

Associated professor

Tokat Gaziosmanpasa University

研究点 (2)

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