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

NCT07707349 | Completed

• 1 other identifier: REC-D12295-6
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fluorosis, Dental; Enamel Discoloration

Keywords

Enamel Fluorosis; Enamel discoloration; Antivet; Opalusture; Micro abrasion; Spectrophotometer

Outcome Measures

Primary Outcomes (1)

• The mean change in color

  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).

Study Arms (2)

Antivet

EXPERIMENTAL

Other: Antivet

Opalusture microabrasion

ACTIVE COMPARATOR

Other: Opalusture

Interventions

Antivet OTHER

Microabrasion

Antivet

Opalusture OTHER

Enamel Micro abrasion

Opalusture microabrasion

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• October University for Modern Sciences and Arts: lead

Study Sites (1)

October University for Modern Sciences and Arts

Giza, Sixth of October, 12566, Egypt

Location

Related Publications (2)

• 10.21608/edj.2023.217606.2603

  RESULT

• Diab DFS, Elhaddad EEH. Comparative effect of Antivet(R), Oplasture(R), and a prototype paste on color change and microhardness of simulated stained enamel: an in vitro study. BDJ Open. 2025 Dec 30;11(1):100. doi: 10.1038/s41405-025-00393-x.

  PMID: 41469534 RESULT

MeSH Terms

Conditions

Fluorosis, Dental

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the interventions, operator blinding was not feasible. However, the examiner responsible for outcome assessment and the biostatistician performing the statistical analyses were blinded to treatment allocation throughout the study to minimize detection and analysis bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Conservative Dentistry

Model Details: Participants meeting the eligibility criteria were randomly assigned in a 1:1 allocation ratio to one of two parallel treatment groups. The intervention group received Antivet treatment, while the control group underwent enamel microabrasion using Opalustre. Each participant received only one of the two interventions, and treatment allocation remained unchanged throughout the study. The effectiveness of both treatment modalities was evaluated by comparing changes in tooth color before and after treatment using objective spectrophotometric measurements based on the CIELAB color system.

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: July 16, 2026
• Study Start: May 18, 2026
• Primary Completion: June 15, 2026
• Study Completion: July 7, 2026
• Last Updated: July 16, 2026

Record last verified: 2026-05

Locations

EG (1)