Enamel Hypomineralization, DentalNCT07906236
Esthetic Impact of Different Minimally Invasive Approaches on Hypomineralized Permanent Anterior Teeth
A study testing ICON® resin infiltration, Opalustre® enamel microabrasion and Antivet® enamel micro-abrasion in people with Enamel Hypomineralization, Dental, run by Shaimaa Abdelrahman at 1 site in Egypt.
Trial summary
The aim of the study is to determine the effectiveness of minimally invasive treatments in reducing the visible enamel opacities on permanent anterior teeth in children aged from seven to twelve years with hypomineralized lesions. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Enamel Hypomineralization, Dental
- What is being tested?
- ICON® resin infiltration, Opalustre® enamel microabrasion and Antivet® enamel micro-abrasion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2027to 1 Sep 2027
- Phase
- Interventional
- 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 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- ▪ Participants free from any systemic disease aged from 7 years to 12 years
- Anterior permanent teeth with Degree 1(mild) hypomineralization (according to the Wetzel and Reckel scale) (as shown in Appenxix I).
- Enamel opacities, (White, creamy or yellow to brownish colour), without enamel breakdown
- Caries-free teeth.
- Sensitivity to external stimuli e.g., air/water but not brushing.
Who cannot join
- ▪ Dental caries and filling,
- Loss of the enamel or dentin structure,
- Clinical symptoms of irreversible pulpitis such as spontaneous pain or persisting pain,
- Previous use of bleaching agent.
- Dental anomaly on anterior teeth,
- Periodontal diseases,
Show all 9Show fewer
- Undergoing orthodontic treatment,
- Cognitive and behavioral conditions.
- Patients with milk protein or hydroxybenzoates allergies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Dentistry, Cairo University
Cairo
Shaimaa Awad, Mcs, 01027557531, shaimaa.awad@dentistry.cu.edu.eg
About this study
Official title: Esthetic Impact of Different Minimally Invasive Approaches on Hypomineralized Permanent Anterior Teeth: A Randomized Clinical Trial
The aim of the study is to determine the effectiveness of minimally invasive treatments in reducing the visible enamel opacities on permanent anterior teeth in children aged from seven to twelve years with hypomineralized lesions.
A secondary purpose is to evaluate patient satisfaction and the psychosocial impact of the treatment on the esthetic perception of the treated children.
Read more
The results of all the research papers about treating enamel discoloration caused by hypomineralization with the ICON system can be accepted as satisfactory. However, not all cases achieved the full aesthetic aim.
Microabrasion is an acid abrasive removal and not the dissolution of enamel stain. It is as a treatment modality for enamel opacities like brown, orange, or yellow enamel spots; and fluorotic white streaks. Esthetic results could be reached when microabrasion followed by a remineralizing agent such as C PP-ACFP.
Null hypothesis, there is no difference between microabrasion followed by a remineralizing agent and resin infiltration treatment regarding clinical effectiveness \& patient satisfaction.
Read the detailed description
Outcomes:
Primary outcome Color enhancement using Clinical photographs (Bhandari, et al., 2019). Secondary outcomes
- Patient satisfaction will be evaluated using Numerical scale (NS), (Figure 1). The participant marked the number that represented their self-assessed satisfaction (Rocha et al., 2020) as shown in Appenxix II.
- Psychosocial impact of the treatment on the esthetic perception of the treated children will be evaluated using The Psychosocial Impact of Dental Aesthetics Questionnaire (PIDAQ) (Klages et al., 2006). Appendix III.
- Reducing teeth hypersensitivity will be evaluated using The Schiff Cold Air Sensitivity Scale (SCASS) (Schiff et al., 1994).
- Adverse and undesirable side effects experienced by the respondents: a) pain in teeth and gums will be evaluated using The Wong-Baker FACES® Pain Rating Scale (Wong et al., 1988). Appendix IV.
- b) bitter taste will be evaluated by asking the child right after treatment. (Athayde et al., 2022).
- Follow up:
Follow up after 1 day for adverse and undesirable side effects, 1week \& 6 months.
Randomization:
The participants will be randomly assigned to one of the three experimental groups the interventions and control groups using simple randomization with a 1:1 allocation ratio.
Masking/blinding:
Neither the operator nor the patients could be blinded due to the nature of the study but the outcome assessor and statistician will be blinded.
- Conditions
- Enamel Hypomineralization, Dental
- Being tested
- ICON® resin infiltration, Opalustre® enamel microabrasion, Antivet® enamel micro-abrasion
- Keywords
- Hypomineralized enamel; microabrasion
- Medical subject headings
- Dental Enamel Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICON® resin infiltrationOther
- Applying a 15% hydrochloric acid gel (ICON-Etch; DMG; Hamburg, Germany®) for 120 s using the Icon® etch syringe included in the set,
- followed by a thorough washing of the etchant for 30 s. and Dring the tooth using an air spray,
- Once the enamel surface appeared chalky, Ethanol lesion desiccation (ICON-Dry; DMG®) will be performed for 30 s,
- followed by drying using an air spray.
- Using the Icon® infiltrant syringe Infiltration with a sufficient amount resin (ICON-Infiltrate; DMG®) of the lesion surface by massaging the tip of the syringe on the lesion in circular movements for 3 min.
- Before drying, clean the remaining material and excess removal by Gauze or cotton swab and dental floss.
- Light curing for 40 s with a light-cure device,
- Then another round of infiltration will take place
- One minute was provided for the material to infiltrate the pores, after which it was polymerized for 40 s.
Opalustre® enamel microabrasionOther
- Isolation is extremely important because of the hydrochloric acid. Patients and clinician should both wear protective eyewear.
- Isolate teeth to be treated and one tooth posterior on each side using rubber dam.
- For additional protection, apply a bead of rubber dam sealer or light-cured resin barrier at the gingival margin beneath the dam.
NOTE: For hypo-mineralization greater than 0.1-0.3mm use a fine-grit water-cooled tapered diamond bur, lightly sweep over the stained area for 5-10 seconds prior to applying Opalustre.
- Apply approximately 1.0mm thick layer over the discolored area from Opalustre syringe with the White Mac tip.
- Using a rubber prophy cup at a slow RPM (approximately 500 RPM), apply medium to heavy pressure for 60 seconds at a time.
- Suction the paste from the teeth first, then rinse, evaluate and repeat as necessary.
- Aesthetic improvement should be visualized on the wet surfaces.
- After final rinse, remove rubber dam, and sealer from the teeth. Rinse
Antivet® enamel micro-abrasionOther
- The Antivet® abrasive solution (MDC DENTAL, Zapopan Jalisco, México) containing 21% hydrofluoric acid will be placed on the buccal surface with a cotton swab.
- When the swab became pigmented, it will change to another clean swab with the abrasive solution.
- The procedure would be repeated for 10 min.
- When the process is finished, the excess solution will be cleaned using cotton, and calcium hydroxide as a neutralizing solution would be placed for 1 min with a micro brush.
- In the end, rinsing with water for 30 s.
- Apply MI varnish to the enamel.
| Study group | Role | What they receive |
|---|---|---|
| Control group ICON® resin infiltration | Active comparator | Resin infiltration treatment (Icon®) for Hypomineralized anterior permanent teeth in children Receives: Other: ICON® resin infiltration |
| Intervention group 1 | Experimental | Opalustre® Enamel Microabrasion Slurry Receives: Other: Opalustre® enamel microabrasion |
| Intervention group 2 | Experimental | Antivet® enamel micro-abrasion Receives: Other: Antivet® enamel micro-abrasion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Color enhancement measured by Clinical photographs
Clinical photographs will be taken with a digital camera macro lens, and flash. With the patient and digital camera at the same vertical plane and dental clinic illuminated evenly.
The photographs will be taken in baseline, during the application time of the test or control.
For standardizing the photographic conditions, the camera will be placed at the equidistance from the tooth. To prevent the change of refractive index by moisture, 30 s of drying of the lesion will be done.
Measured: 6 months
Secondary outcomes (2)
Patient satisfaction measured by Visual analogue scale
The patient is asked to draw a line perpendicular to the VAS at their perceived pain-intensity level, no discomfort (score 0), mild discomfort (score 1-3), moderate (score 4-6) and very severe (7-9) or worst discomfort (score 10).
Measured: 6 months
Reducing teeth hypersensitivity measured by The Schiff Cold Air Sensitivity Scale (SCASS)
It is a behavioral scale because it is based on observed behavior in response to a stimulus beyond a certain threshold.
The dentist (or another assessor present) rates the response of the patient to the stimulus as 0 for no response to air stimulus,
- for response to air stimulus but no request for discontinuation of the stimulus,
- for response to air stimulus and requests discontinuation or moves from the stimulus\&
- for response to air stimulus, considers stimulus to be painful, and requests discontinuation'
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enamel Hypomineralization, 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaimaa Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shaimaa Abdelrahman, Cairo University
- Investigators
- Shaimaa AM Awad, Mcs, Principal investigator, Cairo Uviversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07906236
- Sponsor's protocol ID
- 261711198415920202321948291954
- Status last verified
- Sep 2026
- First submitted
- 24 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esthetic Impact of Different Minimally Invasive Approaches on Hypomineralized Permanent Anterior Teeth: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07906236
- Acronym / sponsor ID
- 261711198415920202321948291954
- Conditions
- Enamel Hypomineralization, Dental
- Keywords
- Hypomineralized enamel; microabrasion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Shaimaa AbdelrahmanUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 30 Oct 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.
The aim of the study is to determine the effectiveness of minimally invasive treatments in reducing the visible enamel opacities on permanent anterior teeth in children aged from seven to twelve years with hypomineralized lesions.
A secondary purpose is to evaluate patient satisfaction and the psychosocial impact of the treatment on the esthetic perception of the treated children.
The results of all the research papers about treating enamel discoloration caused by hypomineralization with the ICON system can be accepted as satisfactory. However, not all cases achieved the full aesthetic aim.
Microabrasion is an acid abrasive removal and not the dissolution of enamel stain. It is as a treatment modality for enamel opacities like brown, orange, or yellow enamel spots; and fluorotic white streaks. Esthetic results could be reached when microabrasion followed by a remineralizing agent such as C PP-ACFP.
Null hypothesis, there is no difference between microabrasion followed by a remineralizing agent and resin infiltration treatment regarding clinical effectiveness \& patient satisfaction.
Detailed description
Outcomes:
Primary outcome Color enhancement using Clinical photographs (Bhandari, et al., 2019). Secondary outcomes
- Patient satisfaction will be evaluated using Numerical scale (NS), (Figure 1). The participant marked the number that represented their self-assessed satisfaction (Rocha et al., 2020) as shown in Appenxix II.
- Psychosocial impact of the treatment on the esthetic perception of the treated children will be evaluated using The Psychosocial Impact of Dental Aesthetics Questionnaire (PIDAQ) (Klages et al., 2006). Appendix III.
- Reducing teeth hypersensitivity will be evaluated using The Schiff Cold Air Sensitivity Scale (SCASS) (Schiff et al., 1994).
- Adverse and undesirable side effects experienced by the respondents: a) pain in teeth and gums will be evaluated using The Wong-Baker FACES® Pain Rating Scale (Wong et al., 1988). Appendix IV.
- b) bitter taste will be evaluated by asking the child right after treatment. (Athayde et al., 2022).
- Follow up:
Follow up after 1 day for adverse and undesirable side effects, 1week \& 6 months.
Randomization:
The participants will be randomly assigned to one of the three experimental groups the interventions and control groups using simple randomization with a 1:1 allocation ratio.
Masking/blinding:
Neither the operator nor the patients could be blinded due to the nature of the study but the outcome assessor and statistician will be blinded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group ICON® resin infiltration | Active comparator | Other: ICON® resin infiltrationResin infiltration treatment (Icon®) for Hypomineralized anterior permanent teeth in children |
| Intervention group 1 | Experimental | Other: Opalustre® enamel microabrasionOpalustre® Enamel Microabrasion Slurry |
| Intervention group 2 | Experimental | Other: Antivet® enamel micro-abrasionAntivet® enamel micro-abrasion |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- ▪ Participants free from any systemic disease aged from 7 years to 12 years
Key exclusion criteria (9 listed)
- ▪ Dental caries and filling,
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 |
|---|---|---|
| ICON® resin infiltration* Applying a 15% hydrochloric acid gel (ICON-Etch; DMG; Hamburg, Germany®) for 120 s using the Icon® etch syringe included in the set, * followed by a thorough washing of the etchant for 30 s. and Dring the tooth using an air spray, * Once the enamel surface appeared chalky, Ethanol lesion desiccation (ICON-Dry; DMG®) will be performed for 30 s, * followed by drying using an air spray. * Using the Icon® infiltrant syringe Infiltration with a sufficient amount resin (ICON-Infiltrate; DMG®) of the lesion surface by massaging the tip of the syringe on the lesion in circular movements for 3 min. * Before drying, clean the remaining material and excess removal by Gauze or cotton swab and dental floss. * Light curing for 40 s with a light-cure device, * Then another round of infiltration will take place * One minute was provided for the material to infiltrate the pores, after which it was polymerized for 40 s. | Other | Control group ICON® resin infiltration |
| Opalustre® enamel microabrasion* Isolation is extremely important because of the hydrochloric acid. Patients and clinician should both wear protective eyewear. * Isolate teeth to be treated and one tooth posterior on each side using rubber dam. * For additional protection, apply a bead of rubber dam sealer or light-cured resin barrier at the gingival margin beneath the dam. NOTE: For hypo-mineralization greater than 0.1-0.3mm use a fine-grit water-cooled tapered diamond bur, lightly sweep over the stained area for 5-10 seconds prior to applying Opalustre. * Apply approximately 1.0mm thick layer over the discolored area from Opalustre syringe with the White Mac tip. * Using a rubber prophy cup at a slow RPM (approximately 500 RPM), apply medium to heavy pressure for 60 seconds at a time. * Suction the paste from the teeth first, then rinse, evaluate and repeat as necessary. * Aesthetic improvement should be visualized on the wet surfaces. * After final rinse, remove rubber dam, and sealer from the teeth. Rinse | Other | Intervention group 1 |
| Antivet® enamel micro-abrasion* The Antivet® abrasive solution (MDC DENTAL, Zapopan Jalisco, México) containing 21% hydrofluoric acid will be placed on the buccal surface with a cotton swab. * When the swab became pigmented, it will change to another clean swab with the abrasive solution. * The procedure would be repeated for 10 min. * When the process is finished, the excess solution will be cleaned using cotton, and calcium hydroxide as a neutralizing solution would be placed for 1 min with a micro brush. * In the end, rinsing with water for 30 s. * Apply MI varnish to the enamel. | Other | Intervention group 2 |
Primary outcome
Color enhancement measured by Clinical photographs
Time frame: 6 months
Clinical photographs will be taken with a digital camera macro lens, and flash. With the patient and digital camera at the same vertical plane and dental clinic illuminated evenly. The photographs will be taken in baseline, during the application time of the test or control. For standardizing the photographic conditions, the camera will be placed at the equidistance from the tooth. To prevent the change of refractive index by moisture, 30 s of drying of the lesion will be done.
2 secondary outcomes
Patient satisfaction measured by Visual analogue scale
Time frame: 6 months
Reducing teeth hypersensitivity measured by The Schiff Cold Air Sensitivity Scale (SCASS)
Time frame: 6 months
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 5 Nov 2026.
- Individual participant dataSharing planned: No
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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.
Shaimaa AM Awad, Mcs principal investigator
Cairo Uviversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICON® resin infiltration, Opalustre® enamel microabrasion and Antivet® enamel micro-abrasion in people with Enamel Hypomineralization, Dental, run by Shaimaa Abdelrahman 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 5 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: opening soon, as of the sponsor's last update on 5 Nov 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?
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 Shaimaa AM Awad, Mcs (01027557531, shaimaa.awad@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Color enhancement measured by Clinical photographs (time frame: 6 months). 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 5 Nov 2026.