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The Effectiveness of Antivet Versus Opalustre® for the Management of Enamel Fluorosis/Discolored Enamel and Its Impact on Aesthetic Outcomes.

2026年7月15日 更新者:Shereen Assem、October University for Modern Sciences and Arts

The Effectiveness of Antivet Versus Opalustre® for the Management of Enamel Fluorosis/Discolored Enamel and Its Impact on Aesthetic Outcomes. A Randomized Controlled Trial

Dental fluorosis is a developmental enamel defect characterized by discoloration and altered enamel appearance, which may negatively affect dental esthetics and patient satisfaction. Conservative treatment approaches, including enamel microabrasion and minimally invasive chemical treatments, have been proposed to improve the appearance of affected teeth while preserving tooth structure. However, evidence comparing the effectiveness of these treatment modalities remains limited.

This randomized controlled clinical trial aims to compare the effectiveness of Antivet treatment and Opalustre enamel microabrasion in improving the esthetic appearance of mild enamel fluorosis/discolored enamel affecting anterior teeth. Eligible participants with mild enamel fluorosis will be randomly allocated to receive either Antivet treatment or Opalustre enamel microabrasion in a 1:1 ratio. Tooth color will be objectively assessed before and after treatment using a spectrophotometer based on the CIELAB color system (L*, a*, and b* coordinates), and the overall color difference (ΔE) will be calculated. The primary outcome is the change in tooth color following treatment, while secondary outcomes include changes in individual CIELAB color coordinates. The findings of this study are expected to provide evidence regarding the comparative effectiveness of these minimally invasive treatment modalities for the esthetic management of mild enamel fluorosis.

研究概览

详细说明

Dental fluorosis is a developmental enamel defect resulting from excessive fluoride intake during enamel formation. It is characterized by varying degrees of enamel opacity, discoloration, and surface irregularities that may compromise dental esthetics and negatively affect patients' quality of life. Conservative treatment approaches are preferred for managing mild fluorosis because they preserve sound tooth structure while improving esthetic appearance. Among these approaches, enamel microabrasion has been widely used to remove superficial enamel discolorations through the combined action of hydrochloric acid and abrasive particles. More recently, minimally invasive chemical treatment systems, such as Antivet, have been introduced as alternative treatment options for improving enamel discoloration while minimizing the removal of sound enamel.

Although both treatment modalities have demonstrated favorable clinical outcomes, evidence directly comparing their effectiveness in improving tooth color remains limited. Therefore, this randomized controlled clinical trial was designed to compare the esthetic outcomes of Antivet treatment and Opalustre enamel microabrasion in the management of mild enamel fluorosis affecting anterior teeth.

Eligible participants presenting with mild enamel fluorosis involving permanent maxillary or mandibular anterior teeth were randomly assigned in a 1:1 allocation ratio to receive either Antivet treatment or Opalustre enamel microabrasion. All treatment procedures were performed according to the manufacturers' recommendations under rubber dam isolation to ensure adequate moisture control and protection of the surrounding soft tissues.

The primary outcome measure was the change in tooth color following treatment, objectively assessed using a spectrophotometer based on the Commission Internationale de l'Éclairage (CIELAB) color system. Color coordinates (L*, a*, and b*) were recorded before and after treatment, and the overall color difference (ΔE) was calculated to quantify treatment-induced color improvement. Secondary outcome measures included changes in individual CIELAB color coordinates, including lightness (L*), red-green chromaticity (a*), and yellow-blue chromaticity (b*).

Statistical analysis included paired-samples and independent-samples t-tests to evaluate within-group and between-group differences. Because baseline differences in chromaticity were identified, analysis of covariance (ANCOVA) was performed using baseline color values as covariates to provide adjusted comparisons between treatment groups. Statistical significance was established at a two-sided α level of 0.05.

The findings of this study are expected to provide high-quality clinical evidence regarding the comparative effectiveness of two minimally invasive treatment modalities for improving the esthetic appearance of fluorosis-affected anterior teeth. The results may assist clinicians in selecting conservative treatment approaches that optimize esthetic outcomes while preserving enamel structure.

研究类型

介入性

注册 (实际的)

59

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Sixth of October
      • Giza、Sixth of October、埃及、12566
        • October university for modern sciences and arts

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

Inclusion Criteria:

  1. Patients aged from 20-35 years old.
  2. Patients free from any systematic diseases.
  3. Patients agreed to the informed consent and are compliant to the follow-up periods.
  4. Teenagers and young adult patients refrained from tobacco products throughout the current study period.
  5. Patients with hypominerlized maxillary and mandibular ante- rior teeth (incisors and canines) were included.
  6. Teeth with Degree 1 (mild) according to the Wetzel and Reckel scale.

Exclusion criteria

  1. Patients with special health care needs or any systemic disease that may delay normal healing.
  2. Patients having bad oral hygiene.
  3. Patients who could not be committed to the follow-up period.
  4. Patients suffering from untreated, periodontal diseases
  5. Participants with caries lesions or defective restorations in the anterior teeth.
  6. Sensitive and fractured teeth.
  7. Participants who had a history of dental bleaching.
  8. Patients participating in other dental studies.
  9. Patients suffering from hypoplasia, amelogenesis imperfecta, dentinogenesis imperfecta, tetracycline stains, fluorosis, or badly broken and missing teeth due to MIH.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:Antivet
Microabrasion
有源比较器:Opalusture microabrasion
Enamel Micro abrasion

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
The mean change in color
大体时间:Baseline (before treatment) and immediately after completion of the intervention (same visit Day 1).
The primary outcome measure was the change in tooth color following treatment, objectively assessed using a spectrophotometer based on the Commission Internationale de l'Éclairage (CIELAB) color system. Color coordinates (L*, a*, and b*) were recorded at the base line and then after the intervention was applied in the same visit and the overall color difference (ΔE) was calculated to quantify treatment-induced color improvement.
Baseline (before treatment) and immediately after completion of the intervention (same visit Day 1).

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月18日

初级完成 (实际的)

2026年6月15日

研究完成 (实际的)

2026年7月7日

研究注册日期

首次提交

2026年7月9日

首先提交符合 QC 标准的

2026年7月15日

首次发布 (实际的)

2026年7月16日

研究记录更新

最后更新发布 (实际的)

2026年7月16日

上次提交的符合 QC 标准的更新

2026年7月15日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

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