Enamel DiscolorationPhase 4NCT06949878
21% Hydrochloric Acid Based Versus 6.6 % Hydrochloric Based Micro Abrasive Kit in Management of Patients With Mild to Moderate Fluorosis
A Phase 4 study testing Antivet and opalustre in people with Enamel Discoloration and Fluorosis, Dental, run by Cairo University.
Trial summary
compare the clinical performance of different concentrations of hydrochloric acid based as micro abrasive kits in management of patients with mild to moderate fluorosis over 6month follow up . Read more about this study
- Who is it for?
- Ages 15 to 45 years
- Conditions the study is for
- Enamel Discoloration, Fluorosis, Dental
- What is being tested?
- Antivet and opalustre
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- May 2025to Aug 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 15 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients who wanted to change the appearance of their stained teeth Males or females. Patients with three or more stained incisors and canines Patients willing and able to attend periodic follow-up visits Patient concerning with oral health. Co-operative patients who show interest to participate in the study.
Who cannot join
- Patients with known allergic or adverse reaction to the tested materials. Smoking habit Patients having Poor oral hygiene Patients with special health care needs or any systemic disease that may affect treatment Patients participating in other dental studies. Patients suffering from white spot lesion, hypoplasia, amelogenesis imperfecta, dentinogenesis imperfecta, or badly broken and missing teeth due to MIH.
- Participants who had a history of dental bleaching.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Yaqeen A Abdel-Razeq, Master's candidate contact
About this study
Official title: Clinical Evaluation of Different Concentrations of Hydrochloric Acid Based as Micro Abrasive Kits in Management of Patients With Mild to Moderate Fluorosis (A 6month Randomized Clinical Trial)
compare the clinical performance of different concentrations of hydrochloric acid based as micro abrasive kits in management of patients with mild to moderate fluorosis over 6month follow up .
Read the detailed description
microabrasion is a permanent cosmetic dentistry treatment indeed to preserve the health of all part of any defect in enamel.
- Conditions
- Enamel Discoloration, Fluorosis, Dental
- Being tested
- Antivet, opalustre
- Keywords
- Dental fluorosis, Microabrasion, Enamel Discoloration, Patient Reported Outcome Measures, Randomized clinical trial, High consentration hydrochloric acid based microabrasive kit(Antivet), Low consentration hydrochloric acid based microabrasive kit ( opalustre)
- Medical subject headings
- Fluorosis, Dental
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntivetDrug
Complete stain removal from the Enamel-Use a compact cotton swab (3 mm) to apply Antivet solution (Dental Continental, México)to the stained dental piece according to manufacturer's instructions.-Replace the swab as it becomes stained and continue until the stain is removed. " This may take 1-5 minutes per tooth, but do not exceed 15 minutes in total. " - We will keep the tooth moist during the process for effective results and avoid reusing stained cotton swab.-Then we will apply the neutralizing solution to the tooth with a brush or micro brush, ensuring it reaches the gingival margin. Leave it on for 2 minutes.-Once the antivet solution is neutralized, rinse the area and remove the rubber dam.
opalustreDrug
Complete stain removal from the Enamel. Product will be applied to the surface with a 1 mm thick layer; ten applications of 60s to help penetration of the gel into the enamel.- Using an abrasive rubber cup (OpalCup™ Ultradent) in contra-angle low-speed handpiece at low revolution.- Then will be rinsed with injectable water for 30 seconds between each application.
| Study group | Role | What they receive |
|---|---|---|
| Antivet | Experimental | Complete stain removal from the Enamel Use a compact cotton swab (3 mm) to apply Antivet solution (Dental Continental, México)to the stained dental piece according to manufacturer's instructions.
Replace the swab as it becomes stained and continue until the stain is removed. " This may take 1-5 minutes per tooth, but do not exceed 15 minutes in total. " We will keep the tooth moist during the process for effective results and avoid reusing stained cotton swab.
Then we will apply the neutralizing solution to the tooth with a brush or micro brush, ensuring it reaches the gingival margin. Leave it on for 2 minutes.
Once the antivet solution is neutralized, rinse the area and remove the rubber dam. Receives: Drug: Antivet |
| :opalustre | Experimental | Complete stain removal from the Enamel. Product will be applied to the surface with a 1 mm thick layer; ten applications of 60s to help penetration of the gel into the enamel.
Using an abrasive rubber cup (OpalCup™ Ultradent) in contra-angle low-speed handpiece at low revolution.
Then will be rinsed with injectable water for 30 seconds between each application Receives: Drug: opalustre |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical assessment of treatment success
Enamel discoloration or texture by Spectrophotometer Vita EasyShade When totally removed of fluorotic white spots = success \& when stains doesn't removed and surface irregular = failure
Measured: T( Time ) T0(base line )=Immediately , T1 = 3 Months , T2 = 6 Month
Secondary outcomes (2)
Clinical evaluation of Sensitivity
Patient reported outcome measures by visual analog scale (VAS) Is used to describe sensitivity by patient themselves in scores as ( o : no sensitivity) ( 10 : highly sensitive )
Measured: Time frame : T( Time ) T0(base line )=Immediately , T1 = 3 Months , T2 = 6 Month
Patient satisfaction with the Treatment.
Patient reported outcome measures by 4-point Likert scale used to describe patient satisfaction with treatment as [(a) "yes, very satisfied", (b) "yes, mostly satisfied", (c) "less satisfied", (d) "not at all satisfied"].
Measured: Time frame : T( Time ) T0(base line )=Immediately , T1 = 3 Months , T2 = 6 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study startMay 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enamel DiscolorationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yaqeen Atef AbdelRazeq Mohammed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06949878
- Sponsor's protocol ID
- Opertive 4
- Status last verified
- Apr 2025
- First submitted
- 22 Apr 2025
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Different Concentrations of Hydrochloric Acid Based as Micro Abrasive Kits in Management of Patients With Mild to Moderate Fluorosis (A 6month Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT06949878
- Acronym / sponsor ID
- Opertive 4
- Conditions
- Enamel Discoloration, Fluorosis, Dental
- Keywords
- Dental fluorosis, Microabrasion, Enamel Discoloration, Patient Reported Outcome Measures, Randomized clinical trial, High consentration hydrochloric acid based microabrasive kit(Antivet), Low consentration hydrochloric acid based microabrasive kit ( opalustre)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 29 Apr 2025 (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.
compare the clinical performance of different concentrations of hydrochloric acid based as micro abrasive kits in management of patients with mild to moderate fluorosis over 6month follow up .
Detailed description
microabrasion is a permanent cosmetic dentistry treatment indeed to preserve the health of all part of any defect in enamel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antivet | Experimental | Drug: AntivetComplete stain removal from the Enamel Use a compact cotton swab (3 mm) to apply Antivet solution (Dental Continental, México)to the stained dental piece according to manufacturer's instructions. Replace the swab as it becomes stained and continue until the stain is removed. " This may take 1-5 minutes per tooth, but do not exceed 15 minutes in total. " We will keep the tooth moist during the process for effective results and avoid reusing stained cotton swab. Then we will apply the neutralizing solution to the tooth with a brush or micro brush, ensuring it reaches the gingival margin. Leave it on for 2 minutes. Once the antivet solution is neutralized, rinse the area and remove the rubber dam. |
| :opalustre | Experimental | Drug: opalustreComplete stain removal from the Enamel. Product will be applied to the surface with a 1 mm thick layer; ten applications of 60s to help penetration of the gel into the enamel. Using an abrasive rubber cup (OpalCup™ Ultradent) in contra-angle low-speed handpiece at low revolution. Then will be rinsed with injectable water for 30 seconds between each application |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients who wanted to change the appearance of their stained teeth Males or females. Patients with three or more stained incisors and canines Patients willing and able to attend periodic follow-up visits Patient concerning with oral health. Co-operative patients who show interest to participate in the study.
Key exclusion criteria (2 listed)
- Patients with known allergic or adverse reaction to the tested materials. Smoking habit Patients having Poor oral hygiene Patients with special health care needs or any systemic disease that may affect treatment Patients participating in other dental studies. Patients suffering from white spot lesion, hypoplasia, amelogenesis imperfecta, dentinogenesis imperfecta, or badly broken and missing teeth due to MIH.
- Participants who had a history of dental bleaching.
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 |
|---|---|---|
| AntivetComplete stain removal from the Enamel-Use a compact cotton swab (3 mm) to apply Antivet solution (Dental Continental, México)to the stained dental piece according to manufacturer's instructions.-Replace the swab as it becomes stained and continue until the stain is removed. " This may take 1-5 minutes per tooth, but do not exceed 15 minutes in total. " - We will keep the tooth moist during the process for effective results and avoid reusing stained cotton swab.-Then we will apply the neutralizing solution to the tooth with a brush or micro brush, ensuring it reaches the gingival margin. Leave it on for 2 minutes.-Once the antivet solution is neutralized, rinse the area and remove the rubber dam. | Drug | Antivet |
| opalustreComplete stain removal from the Enamel. Product will be applied to the surface with a 1 mm thick layer; ten applications of 60s to help penetration of the gel into the enamel.- Using an abrasive rubber cup (OpalCup™ Ultradent) in contra-angle low-speed handpiece at low revolution.- Then will be rinsed with injectable water for 30 seconds between each application. | Drug | :opalustre |
Primary outcome
Clinical assessment of treatment success
Time frame: T( Time ) T0(base line )=Immediately , T1 = 3 Months , T2 = 6 Month
Enamel discoloration or texture by Spectrophotometer Vita EasyShade When totally removed of fluorotic white spots = success \& when stains doesn't removed and surface irregular = failure
2 secondary outcomes
Clinical evaluation of Sensitivity
Time frame: Time frame : T( Time ) T0(base line )=Immediately , T1 = 3 Months , T2 = 6 Month
Patient satisfaction with the Treatment.
Time frame: Time frame : T( Time ) T0(base line )=Immediately , T1 = 3 Months , T2 = 6 Month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Individual participant dataSharing planned: Yes
Related trials for Enamel Discoloration
Recruiting
Tooth Discoloration and Chairside Handling Time (Bonding-Debonding) in Flowable Versus Packable Composites for Clear Aligner Bonded Attachments: A Randomized Clinical Trial
Clear Aligner Orthodontic Treatment, Composite Attachment
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.
Yaqeen A Abdel-Razeq, Master's candidate contact
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Antivet and opalustre in people with Enamel Discoloration and Fluorosis, Dental, run by Cairo University.
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 1 inclusion and 2 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: opening soon, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yaqeen A Abdel-Razeq, Master's candidate (0020201018769392 ext. 0201121159913, yaqeen.atef@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical assessment of treatment success (time frame: T( Time ) T0(base line )=Immediately , T1 = 3 Months , T2 = 6 Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2025.