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临床试验/NCT07162077
NCT07162077已完成不适用

The Effectiveness of Sodium Hypochlorite Application in Managing Opacities of Molar-incisor Hypomineralization on Incisors Using Resin Infiltration

Latakia University2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2025年8月25日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
2
主要终点
Masking efficacy

研究概览

简要总结

Objectives: to compare aesthetic effectiveness of resin infiltration with/without using sodium hypochlorite in managing opacities of MIH on incisors, and to compare parent's satisfaction with results of both application protocols.

Methods: Twenty-four teeth with yellow/ brown opacities of MIH, will be diagnosed according to EAPD diagnostic criteria, will be randomly allocated to test or control group. In the test group, the investigators will be applied sodium hypochlorite 5.25% by using cotton wad before treatment, then after the first and second etching cycles (application of the Icon-Etch (ICON® -Etch; DMG, Hamburg, Germany) and Icon-dry (ICON® -Dry; DMG, Hamburg, Germany) according to the manufacturer's recommendations) as irrigation step and following the third -Etch etching cycle Icon-infiltrant (ICON® -Infiltrant; DMG, Hamburg, Germany) will be applied . In control group, the investigators will be applied the same protocol of test group but without using sodium hypochlorite. The masking efficacy will be analyzed using the Lab System to calculate the color difference (ΔE) between the opacity and the adjacent enamel in Adobe Photoshop 2024. The infiltration proportion of opacity will be measured using Image J software and the infiltrated area will be expressed as a percentage. The satisfaction of the parents with the results of both application protocols will be compared using Likert scale.

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

性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with MIH-related opacities on the incisal and middle thirds of the buccal surface of their permanent incisors, ac- cording to EAPD diagnostic criteria of (MIH), only isolated lesions will be selected.

排除标准

  • Teeth with resin composite restorations, previously treated by exter- nal bleaching, micro-abrasion or re-mineralization(fluoride varnish or calcium-based products such asCPP-ACP) will be excluded.
  • Opacities present only on incisors without molar
  • WSLs caused by orthodomtic treatment
  • Teeth affected by dental fluorosis, Amelogenesis imperfecta and Tetracycline-pigmented teeth

研究组 & 干预措施

Sodium hypochlorite & ICON

Experimental

Resin infitration ( ICON (DMG, Hamburg, Germany)) and sodium hypochlorite 5.25%

干预措施: Sodium hypochlorite 5.25% (Procedure)

ICON

Active Comparator

Resin infiltration ( ICON (DMG, Hamburg, Germany))

干预措施: ICON resin infiltration Material group in vivo (Procedure)

结局指标

主要结局

Masking efficacy

时间窗: The masking efficacy will be analyzed on day 1 and (7 - 10) days after day 1

The masking efficacy will be analyzed using the Lab System to calculate the color difference (ΔE) between the opacity and the adjacent enamel in Adobe Photoshop 2024.

次要结局

  • The satisfaction of the parents(On day 1 and (7-10) days after)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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