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

15 juillet 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

59

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Sixth of October
      • Giza, Sixth of October, Egypte, 12566
        • October university for modern sciences and arts

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Antivet
Microabrasion
Comparateur actif: Opalusture microabrasion
Enamel Micro abrasion

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
The mean change in color
Délai: 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).

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

18 mai 2026

Achèvement primaire (Réel)

15 juin 2026

Achèvement de l'étude (Réel)

7 juillet 2026

Dates d'inscription aux études

Première soumission

9 juillet 2026

Première soumission répondant aux critères de contrôle qualité

15 juillet 2026

Première publication (Réel)

16 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

16 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

15 juillet 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

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INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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