Molar Incisor HypomineralizationNCT07873268
Molar-Incisor Hypomineralization and Resin Infiltration
A study testing Resin infiltration and Fluoride Varnishes in people with Molar Incisor Hypomineralization, run by Hanoi Medical University at 3 sites in Vietnam.
Trial summary
This dual-design study-encompassing a cross-sectional descriptive phase and a controlled clinical trial-aims to investigate the prevalence and associated risk factors of Molar Incisor Hypomineralization (MIH), while evaluating the therapeutic efficacy of resin infiltration (ICON) for treating mild MIH lesions in… Read more about this study
- Who is it for?
- Ages 7 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Molar Incisor Hypomineralization
- What is being tested?
- Resin infiltration and Fluoride Varnishes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 3 sitesVietnam
- Study dates
- 2 Oct 2023to 10 Dec 2026
- 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 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 7 to 11 years.
- Children diagnosed with mild Molar-Incisor Hypomineralization (MIH) according to EAPD criteria on permanent incisors.
- Permanent incisors with intact anatomical shape, showing smooth enamel surfaces or minor defect depth without post-eruptive enamel breakdown (PEB).
- Children and parents/guardians willing to participate and sign the informed consent form.
Who cannot join
- Children with severe MIH lesions accompanied by post-eruptive enamel breakdown (PEB), atypical restorations, or dental caries.
- Permanent incisors with developmental anomalies, fluorosis, amelogenesis imperfecta, dentinogenesis imperfecta, or severe enamel hypoplasia.
- Teeth undergoing active orthodontic treatment or presenting with fixed orthodontic appliances.
- Non-vital teeth, teeth with symptoms of pulpitis, apical periodontitis, or history of endodontic treatment.
- Children with systemic diseases, chronic physical/mental conditions, or severe uncooperative behavior during dental procedures.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam3 sites, 3 recruiting
- Recruiting
Hanoi Medical University
Hanoi, North, 100000
Huyen DDS. MsC, 0932481617, minhxinhdep1510@gmail.com
- Recruiting
National Institute Of Hygiene And Epidemiology
Hanoi, North, 100000
Phuong Huyen Nguyen DDS.MsC. Nguyen Phuong Huyen, (+84) 932481617, minhxinhdep1510@gmail.com
- Recruiting
National of Odonto-Stomatology, Hanoi
Hanoi, North, 100000
Phuong Huyen Nguyen DDS.MsC. Nguyen Phuong Huyen, 0932481617, minhxinhdep1510@gmail.com
About this study
Official title: Prevalence of Molar-Incisor Hypomineralization (MIH) and Effectiveness of Resin Infiltration Treatment
This dual-design study-encompassing a cross-sectional descriptive phase and a controlled clinical trial-aims to investigate the prevalence and associated risk factors of Molar Incisor Hypomineralization (MIH), while evaluating the therapeutic efficacy of resin infiltration (ICON) for treating mild MIH lesions in permanent incisors among school children aged 7 to 11 years across selected primary schools in Northern Vietnam. The primary research questions seek to delineate the current epidemiological profile of MIH alongside its pre-, peri-, and postnatal biological determinants, while assessing the longitudinal clinical outcomes of resin infiltration (ICON) regarding color change ΔE, lesion depth penetration, and aesthetic restoration compared to control groups. In the interventional phase, outcomes of the resin infiltration cohort will be evaluated against control protocols (such as topical fluoride varnish application or observation/untreated controls) to quantify improvements in color stability, remineralization, and defect dimensions. Participating pediatric subjects will undergo comprehensive oral examinations to index MIH severity on first permanent molars and incisors, alongside standardized questionnaire-based interviews with guardians to record medical history. Children presenting with mild incisor defects enrolled in the clinical trial will receive treatment with resin infiltration or comparative controls, followed by standardized digital photography and spectrophotometric color assessment (using the VITA Easyshade V device), with structured post-operative follow-up evaluations scheduled at baseline 1 month, 2nd month, 3rd month, 6th month, and 12th month to measure long-term treatment longevity and outcomes.
- Conditions
- Molar Incisor Hypomineralization
- Being tested
- Resin infiltration, Fluoride Varnishes
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resin infiltrationDrug
Isolation \& Prophylaxis: Clean target enamel with fluoride-free paste. Apply rubber dam isolation to protect soft tissues.
Acid Etching: Apply Icon-Etch (15% HCl) for 2 minutes with light mechanical agitation. Rinse with water for > 30 seconds and air-dry.
Desiccation \& Optical Verification: Apply Icon-Dry (99% ethanol) for 30 seconds and air-dry. Verify lesion masking visually; repeat etching step if opaque discoloration remains (up to 3 cycles).
First Infiltration: Apply Icon-Infiltrant for 3 minutes. Floss interproximally, remove excess resin with gentle air stream, and light-cure for 40 seconds.
Second Infiltration \& Finishing: Re-apply Icon-Infiltrant for 1 minute. Remove excess resin, light-cure for 40 seconds, remove isolation, and polish with fine finishing discs.
Fluoride VarnishesDrug
Teeth were cleaned with prophylaxis paste, isolated with cotton rolls, and dried. A thin layer of 5% sodium fluoride (NaF) varnish was applied using a microbrush. Patients were instructed to refrain from eating, drinking, or toothbrushing for at least 4 hours post-treatment to allow optimal remineralization. Follow-up evaluations were conducted at T1, T2, T3, T6, and T12 months.
| Study group | Role | What they receive |
|---|---|---|
| Varnish Fluoride | Active comparator | Permanent incisors affected by mild molar-incisor hypomineralization (MIH) treated with 5% sodium fluoride varnish (NaF) application following standard prophylaxis and drying protocols. Receives: Drug: Fluoride Varnishes |
| Resin Infiltration | Experimental | Incisors with mild MIH treated with resin infiltration (Icon, DMG, Germany) following standard etching, drying, and light-curing protocols. Receives: Drug: Resin infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Color Improvement and Lesion Masking Effect
Assessment of esthetic improvement and color masking of hypomineralized enamel lesions using digital spectrophotometry or standardized visual aesthetic indices (e.g., VAS / Color Difference delta E).
Measured: Baseline, 1 month, 3 months, 6 months, and 12 months post-treatment
Secondary outcomes (3)
Enamel Surface Integrity
Structural stability/breakdown of the treated enamel surfaces.
Measured: Baseline, 1 month, 3 months, 6 months, and 12 months post-treatment
Tooth Hypersensitivity Assessed by Visual Analog Scale (VAS)
Tooth hypersensitivity is self-reported by the subject using a 10-cm Visual Analog Scale (VAS) ranging from 0 to 10 following thermal/air stimulation. Score 0 indicates "no pain or discomfort" and score 10 indicates "worst possible pain". Higher scores indicate greater hypersensitivity (worse outcome).
Measured: Baseline, 1 month, 3 months, 6 months, and 12 months post-treatment
Tooth Hypersensitivity Assessed by Schiff Cold Air Sensitivity Scale (SCASS)
Tooth hypersensitivity is evaluated in response to a 1-second blast of cold air from a dental air syringe applied to the affected tooth surface. Sensitivity is scored using the Schiff Cold Air Sensitivity Scale ranging from 0 to 3: 0 = Tooth/subject does not respond to air stimulus; 1 = Tooth/subject responds to air stimulus but does not request discontinuation; 2 = Tooth/subject responds to air stimulus and requests discontinuation or moves from stimulus; 3 = Tooth/subject responds to air stimulus, considers stimulus painful, and requests discontinuation. Higher scores indicate greater hypersensitivity (worse outcome).
Measured: Baseline, 1 month, 3 months, 6 months, and 12 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study start2 Oct 2023
- Primary completion10 Oct 2026 (estimated)
- Study completion10 Dec 2026 (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.
- 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
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanoi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07873268
- Sponsor's protocol ID
- HMUIRB1084
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 14 Oct 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 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Molar-Incisor Hypomineralization (MIH) and Effectiveness of Resin Infiltration Treatment
- ClinicalTrials.gov ID
- NCT07873268
- Acronym / sponsor ID
- HMUIRB1084
- Conditions
- Molar Incisor Hypomineralization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hanoi Medical UniversityUniversity, hospital or other
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 10 Oct 2026 (estimated)
- Study completion
- 10 Dec 2026 (estimated)
- First posted
- 14 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.
This dual-design study-encompassing a cross-sectional descriptive phase and a controlled clinical trial-aims to investigate the prevalence and associated risk factors of Molar Incisor Hypomineralization (MIH), while evaluating the therapeutic efficacy of resin infiltration (ICON) for treating mild MIH lesions in permanent incisors among school children aged 7 to 11 years across selected primary schools in Northern Vietnam. The primary research questions seek to delineate the current epidemiological profile of MIH alongside its pre-, peri-, and postnatal biological determinants, while assessing the longitudinal clinical outcomes of resin infiltration (ICON) regarding color change ΔE, lesion depth penetration, and aesthetic restoration compared to control groups. In the interventional phase, outcomes of the resin infiltration cohort will be evaluated against control protocols (such as topical fluoride varnish application or observation/untreated controls) to quantify improvements in color stability, remineralization, and defect dimensions. Participating pediatric subjects will undergo comprehensive oral examinations to index MIH severity on first permanent molars and incisors, alongside standardized questionnaire-based interviews with guardians to record medical history. Children presenting with mild incisor defects enrolled in the clinical trial will receive treatment with resin infiltration or comparative controls, followed by standardized digital photography and spectrophotometric color assessment (using the VITA Easyshade V device), with structured post-operative follow-up evaluations scheduled at baseline 1 month, 2nd month, 3rd month, 6th month, and 12th month to measure long-term treatment longevity and outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Varnish Fluoride | Active comparator | Drug: Fluoride VarnishesPermanent incisors affected by mild molar-incisor hypomineralization (MIH) treated with 5% sodium fluoride varnish (NaF) application following standard prophylaxis and drying protocols. |
| Resin Infiltration | Experimental | Drug: Resin infiltrationIncisors with mild MIH treated with resin infiltration (Icon, DMG, Germany) following standard etching, drying, and light-curing protocols. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 7 to 11 years.
- Children diagnosed with mild Molar-Incisor Hypomineralization (MIH) according to EAPD criteria on permanent incisors.
- Permanent incisors with intact anatomical shape, showing smooth enamel surfaces or minor defect depth without post-eruptive enamel breakdown (PEB).
- Children and parents/guardians willing to participate and sign the informed consent form.
Key exclusion criteria (5 listed)
- Children with severe MIH lesions accompanied by post-eruptive enamel breakdown (PEB), atypical restorations, or dental caries.
- Permanent incisors with developmental anomalies, fluorosis, amelogenesis imperfecta, dentinogenesis imperfecta, or severe enamel hypoplasia.
- Teeth undergoing active orthodontic treatment or presenting with fixed orthodontic appliances.
- Non-vital teeth, teeth with symptoms of pulpitis, apical periodontitis, or history of endodontic treatment.
- Children with systemic diseases, chronic physical/mental conditions, or severe uncooperative behavior during dental procedures.
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 |
|---|---|---|
| Resin infiltrationIsolation \& Prophylaxis: Clean target enamel with fluoride-free paste. Apply rubber dam isolation to protect soft tissues. Acid Etching: Apply Icon-Etch (15% HCl) for 2 minutes with light mechanical agitation. Rinse with water for > 30 seconds and air-dry. Desiccation \& Optical Verification: Apply Icon-Dry (99% ethanol) for 30 seconds and air-dry. Verify lesion masking visually; repeat etching step if opaque discoloration remains (up to 3 cycles). First Infiltration: Apply Icon-Infiltrant for 3 minutes. Floss interproximally, remove excess resin with gentle air stream, and light-cure for 40 seconds. Second Infiltration \& Finishing: Re-apply Icon-Infiltrant for 1 minute. Remove excess resin, light-cure for 40 seconds, remove isolation, and polish with fine finishing discs. | Drug | Resin Infiltration |
| Fluoride VarnishesTeeth were cleaned with prophylaxis paste, isolated with cotton rolls, and dried. A thin layer of 5% sodium fluoride (NaF) varnish was applied using a microbrush. Patients were instructed to refrain from eating, drinking, or toothbrushing for at least 4 hours post-treatment to allow optimal remineralization. Follow-up evaluations were conducted at T1, T2, T3, T6, and T12 months. | Drug | Varnish Fluoride |
Primary outcome
Color Improvement and Lesion Masking Effect
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months post-treatment
Assessment of esthetic improvement and color masking of hypomineralized enamel lesions using digital spectrophotometry or standardized visual aesthetic indices (e.g., VAS / Color Difference delta E).
3 secondary outcomes
Enamel Surface Integrity
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months post-treatment
Tooth Hypersensitivity Assessed by Visual Analog Scale (VAS)
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months post-treatment
Tooth Hypersensitivity Assessed by Schiff Cold Air Sensitivity Scale (SCASS)
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months post-treatment
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 14 Oct 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.
National Institute Of Hygiene And Epidemiology
Hanoi, Vietnam
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resin infiltration and Fluoride Varnishes in people with Molar Incisor Hypomineralization, run by Hanoi Medical University at 3 sites in Vietnam.
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 5 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: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Vietnam. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Color Improvement and Lesion Masking Effect (time frame: Baseline, 1 month, 3 months, 6 months, and 12 months post-treatment). 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 14 Oct 2026.