Molar Incisor HypomineralizationNCT07753070
Aesthetic Masking and Resin Infiltration Time in MIH-affected Incisors
A study testing macroabrasion followed by oxidative pretreatment and macroabrasion alone in people with Molar Incisor Hypomineralization, run by Alexandria University at 1 site in Egypt.
Trial summary
Background: Resin infiltration often shows unpredictable outcomes in teeth affected by molar incisor hypomineralisation (MIH) due to variable enamel porosities, hypermineralised surface layers, and elevated protein content. Read more about this study
- Who is it for?
- Ages 8 to 13 years
- Conditions the study is for
- Molar Incisor Hypomineralization
- What is being tested?
- macroabrasion followed by oxidative pretreatment and macroabrasion alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Aug 2026to 30 Mar 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 8 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Healthy children with MIH-related mild white creamy opacities on permanent incisors, code 1 according to the European Academy of Paediatric Dentistry (EAPD) criteria.
- Clinically detectable isolated lesions (whether homogeneous or heterogeneous on the incisal and middle thirds of the buccal surface of the selected teeth.
- Patients with score 3 (positive) or score 4 (definitely positive) according to Frankl behavioral rating scale
- Parents or legal guardians accepting to sign a written consent and join the study
Who cannot join
- MIH-affected permanent incisors with post-eruptive enamel breakdown, cavitated lesions, restorations, or previously treated with surface layer removal or remineralising agents in the previous six months.
- Children with an allergy history
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
Outpatient Clinic of Pediatric dentistry, Faculty of dentistry, Alexandria University, Egypt
Alexandria
Alexandria University
Mariam AbdulAziz, BDS
About this study
Official title: Effectiveness of Transillumination-Guided Surface Pretreatment on Aesthetic Masking and Resin Infiltration Time in MIH-affected Incisors (A Randomised Clinical Trial)
Background: Resin infiltration often shows unpredictable outcomes in teeth affected by molar incisor hypomineralisation (MIH) due to variable enamel porosities, hypermineralised surface layers, and elevated protein content. Different pretreatment modalities alongside modified resin infiltration protocols have been suggested to enhance aesthetic masking and the required resin infiltration time.
Aim: To compare the effectiveness of transillumination-guided 5.25% NaOCl pretreatment following macroabrasion, with macroabrasion alone, each with 10-second hydrochloric acid (HCl) etching intervals, on aesthetic masking and resin infiltration time required in MIH-affected incisors.
- Conditions
- Molar Incisor Hypomineralization
- Being tested
- macroabrasion followed by oxidative pretreatment, macroabrasion alone
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
macroabrasion followed by oxidative pretreatmentOther
Fine-grit aluminum oxide finishing stone under water coolant, using a high-speed handpiece to remove the superficial enamel layer, then 5.25% sodium hypochlorite will be applied to the labial lesion surface and agitated with a microbrush for one minute, then rinsed for 20 seconds.
macroabrasion aloneOther
Fine-grit aluminum oxide finishing stone under water coolant, using a high-speed handpiece to remove the superficial enamel layer,
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Not described Receives: Other: macroabrasion followed by oxidative pretreatment |
| Control Group | Active comparator | Not described Receives: Other: macroabrasion alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in aesthetic masking effectiveness
Transillumination images (T0, Tx, Tmax) will be imported into ImageJ (National Institutes of Health, MD, USA), resized, and superimposed to align the labial surfaces. The labial surface and opacity will be manually outlined to measure their respective surface areas. The opacity area ratio will then be calculated as: R = (AO × 100) / AL, where AO is the opacity area and AL is the total labial surface area
Measured: up to 6 months
Secondary outcomes (3)
change in color stability
- Color stability will be calculated based on the changes in the CIE L*a*b* values over time. The color difference (ΔE) between timepoints will be obtained using the following formula: ΔE=√[(ΔL)2 + (Δa)2 + (Δb)2].
Measured: up to 6 months
Changes in the patient-reported SCASS scores
The Schiff Cold Air Sensitivity Scale (SCASS) was used to assess patient-reported dentin hypersensitivity following an air stimulus. The scale ranges from 0 to 3, where 0 indicates no response to the stimulus, 1 indicates a response without requesting discontinuation, 2 indicates a response accompanied by a request to stop the stimulus or withdrawal from it, and 3 indicates a painful response with an immediate request to discontinue the stimulus and/or marked painful behavior. Higher SCASS scores indicate greater dentin hypersensitivity.
Measured: up to 6 months
change in patient satisfaction
5-point Likert scale for the patients' satisfaction. higher socres mean more satisfaction
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start10 Aug 2026 (estimated)
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Molar Incisor HypomineralizationStudies of the same condition, open and under way.
- More trials run by Alexandria 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07753070
- Sponsor's protocol ID
- 1338-05/2026
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Transillumination-Guided Surface Pretreatment on Aesthetic Masking and Resin Infiltration Time in MIH-affected Incisors (A Randomised Clinical Trial)
- ClinicalTrials.gov ID
- NCT07753070
- Acronym / sponsor ID
- 1338-05/2026
- Conditions
- Molar Incisor Hypomineralization
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 10 Aug 2026 (estimated)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 7 Aug 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.
Background: Resin infiltration often shows unpredictable outcomes in teeth affected by molar incisor hypomineralisation (MIH) due to variable enamel porosities, hypermineralised surface layers, and elevated protein content. Different pretreatment modalities alongside modified resin infiltration protocols have been suggested to enhance aesthetic masking and the required resin infiltration time.
Aim: To compare the effectiveness of transillumination-guided 5.25% NaOCl pretreatment following macroabrasion, with macroabrasion alone, each with 10-second hydrochloric acid (HCl) etching intervals, on aesthetic masking and resin infiltration time required in MIH-affected incisors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Other: macroabrasion followed by oxidative pretreatment |
| Control Group | Active comparator | Other: macroabrasion alone |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy children with MIH-related mild white creamy opacities on permanent incisors, code 1 according to the European Academy of Paediatric Dentistry (EAPD) criteria.
- Clinically detectable isolated lesions (whether homogeneous or heterogeneous on the incisal and middle thirds of the buccal surface of the selected teeth.
- Patients with score 3 (positive) or score 4 (definitely positive) according to Frankl behavioral rating scale
- Parents or legal guardians accepting to sign a written consent and join the study
Key exclusion criteria (2 listed)
- MIH-affected permanent incisors with post-eruptive enamel breakdown, cavitated lesions, restorations, or previously treated with surface layer removal or remineralising agents in the previous six months.
- Children with an allergy history
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 |
|---|---|---|
| macroabrasion followed by oxidative pretreatmentFine-grit aluminum oxide finishing stone under water coolant, using a high-speed handpiece to remove the superficial enamel layer, then 5.25% sodium hypochlorite will be applied to the labial lesion surface and agitated with a microbrush for one minute, then rinsed for 20 seconds. | Other | Test Group |
| macroabrasion aloneFine-grit aluminum oxide finishing stone under water coolant, using a high-speed handpiece to remove the superficial enamel layer, | Other | Control Group |
Primary outcome
change in aesthetic masking effectiveness
Time frame: up to 6 months
Transillumination images (T0, Tx, Tmax) will be imported into ImageJ (National Institutes of Health, MD, USA), resized, and superimposed to align the labial surfaces. The labial surface and opacity will be manually outlined to measure their respective surface areas. The opacity area ratio will then be calculated as: R = (AO × 100) / AL, where AO is the opacity area and AL is the total labial surface area
3 secondary outcomes
change in color stability
Time frame: up to 6 months
Changes in the patient-reported SCASS scores
Time frame: up to 6 months
change in patient satisfaction
Time frame: up to 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 7 Aug 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing macroabrasion followed by oxidative pretreatment and macroabrasion alone in people with Molar Incisor Hypomineralization, run by Alexandria University 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 4 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 7 Aug 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 Maryam AbdulAziz (01033254672, coolmaryomi96@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in aesthetic masking effectiveness (time frame: up to 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 7 Aug 2026.