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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. juli 2026 oppdatert av: 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.

Studieoversikt

Status

Fullført

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

59

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Antivet
Microabrasion
Aktiv komparator: Opalusture microabrasion
Enamel Micro abrasion

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The mean change in color
Tidsramme: 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).

Samarbeidspartnere og etterforskere

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Publikasjoner og nyttige lenker

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Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

18. mai 2026

Primær fullføring (Faktiske)

15. juni 2026

Studiet fullført (Faktiske)

7. juli 2026

Datoer for studieregistrering

Først innsendt

9. juli 2026

Først innsendt som oppfylte QC-kriteriene

15. juli 2026

Først lagt ut (Faktiske)

16. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

16. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. juli 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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