Fluorosis, DentalNCT07707349
The Effectiveness of Antivet Versus Opalustre® for the Management of Enamel Fluorosis/Discolored Enamel and Its Impact on Aesthetic Outcomes.
A study testing Antivet and Opalusture in people with Fluorosis, Dental and Enamel Discoloration, run by October University for Modern Sciences and Arts at 1 site in Egypt.
Trial summary
Dental fluorosis is a developmental enamel defect characterized by discoloration and altered enamel appearance, which may negatively affect dental esthetics and patient satisfaction. Read more about this study
- Who is it for?
- Ages 20 to 35 years
- Conditions the study is for
- Fluorosis, Dental, Enamel Discoloration
- What is being tested?
- Antivet and Opalusture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteEgypt
- Study dates
- 18 May 2026to 7 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
October University for Modern Sciences and Arts
Giza, Sixth of October, 12566
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Fluorosis, Dental, Enamel Discoloration
- Being tested
- Antivet, Opalusture
- Keywords
- Enamel Fluorosis, Enamel discoloration, Antivet, Opalusture, Micro abrasion, Spectrophotometer
- Medical subject headings
- Fluorosis, Dental
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntivetOther
Microabrasion
OpalustureOther
Enamel Micro abrasion
| Study group | Role | What they receive |
|---|---|---|
| Antivet | Experimental | Not described Receives: Other: Antivet |
| Opalusture microabrasion | Active comparator | Not described Receives: Other: Opalusture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (before treatment) and immediately after completion of the intervention (same visit Day 1).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start18 May 2026
- Primary completion15 Jun 2026
- Study completion7 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fluorosis, DentalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- October University for Modern Sciences and Arts
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shereen Assem, October University for Modern Sciences and Arts
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07707349
- Sponsor's protocol ID
- REC-D12295-6
- Status last verified
- May 2026
- First submitted
- 9 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
10.21608/edj.2023.217606.2603
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.
PubMed 41469534
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Antivet Versus Opalustre® for the Management of Enamel Fluorosis/Discolored Enamel and Its Impact on Aesthetic Outcomes. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07707349
- Acronym / sponsor ID
- REC-D12295-6
- Conditions
- Fluorosis, Dental, Enamel Discoloration
- Keywords
- Enamel Fluorosis, Enamel discoloration, Antivet, Opalusture, Micro abrasion, Spectrophotometer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- October University for Modern Sciences and ArtsUniversity, hospital or other
- Study start
- 18 May 2026 (actual)
- Primary completion
- 15 Jun 2026 (actual)
- Study completion
- 7 Jul 2026 (actual)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Antivet | Experimental | Other: Antivet |
| Opalusture microabrasion | Active comparator | Other: Opalusture |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AntivetMicroabrasion | Other | Antivet |
| OpalustureEnamel Micro abrasion | Other | Opalusture microabrasion |
Primary outcome
The mean change in color
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Results publication10.21608/edj.2023.217606.2603
- Results publication: PubMed 41469534Diab 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antivet and Opalusture in people with Fluorosis, Dental and Enamel Discoloration, run by October University for Modern Sciences and Arts at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean change in color (time frame: Baseline (before treatment) and immediately after completion of the intervention (same visit Day 1).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07707349, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.