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临床试验/NCT07770724
NCT07770724尚未招募不适用

Effect of Bioactive Glass Versus Resin Infiltration (ICON) on the Depth of White Spot Lesions: An in Vitro Study

Riphah International University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2026年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
90
试验地点
1
主要终点
Scanning Electron Microscopy

研究概览

简要总结

The aim of this in vitro study is to assess the mean lesion depth improvement and hardness of artificial white spot lesions by comparing the effects of bioactive glass toothpaste and resin infiltration (ICON).

详细描述

White spot lesions are an adverse result of orthodontic treatment caused by poor oral hygiene. It is difficult to maintain oral hygiene during fixed orthodontic treatment.White spot lesions are subsurface enamel porosities due to demineralization of enamel. They are basically the early stages of caries and has milky white appearance. WSLs are usually formed four weeks after bracket placement.There are various methods for the treatment of white spot lesions. The invasive methods include crowns or veneers and microabrasion. The non-invasive methods are remineralizing agents like topical fluoride, bioactive glass, GC Tooth Mousse and resin infiltration material (ICON). Fluoride compounds are one of the first therapies for WSL. Fluoride varnishes inhibit the demineralization process and promotes the remineralization of enamel. The fluoride varnish forms the calcium fluoride on enamel surface and prolong the contact between fluoride and enamel.Previous studies have shown promising results achieved by bioactive glass as compared to other remineralizing agents. Resin infiltration has been introduced recently and there are few studies on the treatment of WSLs. The rationale of the study is to compare the effects of bioactive glass and resin infiltration through scanning electron microscopy and microhardness, as there is limited research on this topic. The purpose of this study is to compare and evaluate the lesion depth of artificial white spot lesions before and after the treatment with sodium fluoride varnish, bioactive glass and resin infiltration (ICON). The null hypothesis is that there are no significant differences among the three groups for the treatment of white spot lesions.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • Upper and lower premolars will be collected from patients undergoing extractions.
  • The teeth should be healthy with no carious lesions.
  • The crown and root morphology of teeth should be normal.
  • The extracted premolar teeth of patients should have no history of previous dental treatment.

排除标准

  • • Fractured premolars due to any cause.
  • Loss of enamel due to parafunctional habits.
  • Presence of enamel anomalies (amelogenesis imperfecta, hypoplasia etc.).
  • Presence of stains, demineralization, decay, fluorosis and restorations

结局指标

主要结局

Scanning Electron Microscopy

时间窗: 4th week

Changes in baseline lesion depth were assessed using scanning electron microscopy. Scanning electron microscopy is used to assess lesion depth before and after treatment with remineralizing agents. Lesion depth is measured in microns. Comparison is made by calculating the average depth of treated samples against untreated demineralized control samples.

Vickers Microhardness Test

时间窗: 4th week

Changes from baseline microhardness tests are used to measure changes in surface hardness before and after remineralization. Sound or artificially demineralized enamel (acid-etched or caries-like lesions) is tested first to set a control value. Agents like fluoride varnishes, CPP-ACP (Casein Phosphopeptide-Amorphous Calcium Phosphate), or bioactive glass are applied over cycles. The percentage surface hardness measures how much demineralized enamel is hardened after remineralization treatment relative to original healthy baseline.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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