Molar Hypomineralization, IncisorMIHNCT07443878
Resin Infiltration vs Ionomer-Based Fluoride Varnish for the Prevention of Post-Eruptive Breakdown in Molars With Mild MIH
A study testing Resin Infiltrant (Icon®, DMG) and Varnish-Modified Glass Ionomer (Clinpro XT®, 3M) in people with Molar Hypomineralization, Incisor, run by Universidad Autonoma de San Luis Potosí at 1 site in Mexico.
Trial summary
round/Objective: The objective of this clinical trial is to evaluate the clinical efficacy of a resin infiltrant (Icon®, DMG) compared to an ionomer-based fluoride varnish (Clinpro XT®, 3M) in preventing post-eruptive enamel breakdown (PEB) in permanent molars with mild Molar Incisor Hypomineralization (MIH). Read more about this study
- Who is it for?
- Ages 6 to 13 years
- Conditions the study is for
- Molar Hypomineralization, Incisor
- What is being tested?
- Resin Infiltrant (Icon®, DMG) and Varnish-Modified Glass Ionomer (Clinpro XT®, 3M)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteMexico
- Study dates
- 23 Sep 2023to 30 Sep 2024
- 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 6 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants with two or more permanent molars affected by mild Molar Incisor Hypomineralization (MIH), graded according to EAPD criteria.
- Mild MIH-affected permanent molars with no history of prior dental treatment.
- Fully erupted or partially erupted permanent molars
- Permanent molars with MIH presenting ICDAS code 0, 1, or 2 (non-cavitated caries lesions).
- Systemically healthy patients.
- Patients (and/or legal guardians) who agree to participate, providing written informed consent and child assent.
Who cannot join
- Presence of only one permanent molar affected by MIH.
- Permanent molars with MIH that already present post-eruptive breakdown (PEB).
- Permanent molars with caries lesions classified as ICDAS 3 or higher.
- Enamel defects of other etiologies in permanent molars (e.g., Amelogenesis Imperfecta, fluorosis, or hypoplasia).
- Patients with systemic diseases or lack of cooperation during dental treatment
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Universidad Autónoma de San Luis Potosí
San Luis Potosí City, San Luis Potosí
About this study
Official title: Resin Infiltration Versus Ionomer-Based Fluoride Varnish to Prevent Post-Eruptive Breakdown in Molars With Mild Molar-Incisor Hypomineralization
round/Objective: The objective of this clinical trial is to evaluate the clinical efficacy of a resin infiltrant (Icon®, DMG) compared to an ionomer-based fluoride varnish (Clinpro XT®, 3M) in preventing post-eruptive enamel breakdown (PEB) in permanent molars with mild Molar Incisor Hypomineralization (MIH).
Research Question: Can resin infiltration effectively prevent post-eruptive enamel breakdown in permanent molars with mild MIH compared to an ionomer-based fluoride varnish? Methodology: The researchers will compare the resin infiltrant Icon® (DMG) with Clinpro XT® Varnish (3M) to prevent post-eruptive enamel breakdown in permanent molars with mild MIH.
Read more
Participants:
Children aged 6 to 13 years presenting at least two permanent molars affected by mild MIH, with no prior structural loss or previous dental treatment.
Requirement to attend follow-up evaluations at 15 days, 1 month, 3 months, and 6 months.
- Conditions
- Molar Hypomineralization, Incisor
- Being tested
- Resin Infiltrant (Icon®, DMG), Varnish-Modified Glass Ionomer (Clinpro XT®, 3M)
- Keywords
- Molar Hypomineralization, Incisor, Preventive Dentistry
- 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 Infiltrant (Icon®, DMG)Other
Application of a low-viscosity light-cured resin (Icon®) after surface pretreatment with 15% hydrochloric acid gel (Icon-Etch). The resin is applied to the affected permanent molar to seal the porous enamel and prevent post-eruptive breakdown.
Varnish-Modified Glass Ionomer (Clinpro XT®, 3M)Other
Application of a site-specific, light-cured varnish-modified glass ionomer (Clinpro XT®). It provides a physical barrier and long-term fluoride release to strengthen the hypomineralized enamel.
| Study group | Role | What they receive |
|---|---|---|
| Resin Infiltrant (Icon®) | Experimental | Participants will receive resin infiltration (Icon®, DMG) on one permanent molar affected by mild MIH. The side (left or right) will be determined by random allocation Receives: Other: Resin Infiltrant (Icon®, DMG) |
| Ionomer-Based Fluoride Varnish (Clinpro XT®) | Active comparator | Participants will receive ionomer-based fluoride varnish (Clinpro XT®, 3M) on the contralateral permanent molar affected by mild MIH Receives: Other: Varnish-Modified Glass Ionomer (Clinpro XT®, 3M) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-eruptive breakdown (PEB)
The primary outcome is the occurrence of Post-Eruptive Breakdown (PEB), defined as the loss of enamel structural integrity resulting in cavitation or a clinical 'step-off' appearance within the hypomineralized area of the permanent molar. This will be recorded as a dichotomous variable (Presence/Absence) based on the European Academy of Paediatric Dentistry (EAPD) diagnostic criteria.
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 posted2 Mar 2026
- Study start23 Sep 2023
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Molar Hypomineralization, IncisorStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a split-mouth study design where each participant receives both interventions in different quadrants
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de San Luis Potosí
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniela Guzmán Uribe, Universidad Autonoma de San Luis Potosí
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07443878
- Sponsor's protocol ID
- CEI-FE-066-023
- Acronym
- MIH
- Status last verified
- Feb 2026
- First submitted
- 23 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nogueira VKC, Mendes Soares IP, Fragelli CMB, Boldieri T, Manton DJ, Bussaneli DG, Cordeiro RCL. Structural integrity of MIH-affected teeth after treatment with fluoride varnish or resin infiltration: An 18-Month randomized clinical trial. J Dent. 2021 Feb;105:103570. doi: 10.1016/j.jdent.2020.103570. Epub 2020 Dec 29.
PubMed 33385533
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resin Infiltration Versus Ionomer-Based Fluoride Varnish to Prevent Post-Eruptive Breakdown in Molars With Mild Molar-Incisor Hypomineralization
- ClinicalTrials.gov ID
- NCT07443878
- Acronym / sponsor ID
- MIH / CEI-FE-066-023
- Conditions
- Molar Hypomineralization, Incisor
- Keywords
- Molar Hypomineralization, Incisor, Preventive Dentistry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Universidad Autonoma de San Luis PotosíUniversity, hospital or other
- Study start
- 23 Sep 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 2 Mar 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.
round/Objective: The objective of this clinical trial is to evaluate the clinical efficacy of a resin infiltrant (Icon®, DMG) compared to an ionomer-based fluoride varnish (Clinpro XT®, 3M) in preventing post-eruptive enamel breakdown (PEB) in permanent molars with mild Molar Incisor Hypomineralization (MIH).
Research Question: Can resin infiltration effectively prevent post-eruptive enamel breakdown in permanent molars with mild MIH compared to an ionomer-based fluoride varnish? Methodology: The researchers will compare the resin infiltrant Icon® (DMG) with Clinpro XT® Varnish (3M) to prevent post-eruptive enamel breakdown in permanent molars with mild MIH.
Participants:
Children aged 6 to 13 years presenting at least two permanent molars affected by mild MIH, with no prior structural loss or previous dental treatment.
Requirement to attend follow-up evaluations at 15 days, 1 month, 3 months, and 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a split-mouth study design where each participant receives both interventions in different quadrants
| Arm | Type | Receives |
|---|---|---|
| Resin Infiltrant (Icon®) | Experimental | Other: Resin Infiltrant (Icon®, DMG)Participants will receive resin infiltration (Icon®, DMG) on one permanent molar affected by mild MIH. The side (left or right) will be determined by random allocation |
| Ionomer-Based Fluoride Varnish (Clinpro XT®) | Active comparator | Other: Varnish-Modified Glass Ionomer (Clinpro XT®, 3M)Participants will receive ionomer-based fluoride varnish (Clinpro XT®, 3M) on the contralateral permanent molar affected by mild MIH |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Participants with two or more permanent molars affected by mild Molar Incisor Hypomineralization (MIH), graded according to EAPD criteria.
- Mild MIH-affected permanent molars with no history of prior dental treatment.
- Fully erupted or partially erupted permanent molars
- Permanent molars with MIH presenting ICDAS code 0, 1, or 2 (non-cavitated caries lesions).
- Systemically healthy patients.
Key exclusion criteria (5 listed)
- Presence of only one permanent molar affected by MIH.
- Permanent molars with MIH that already present post-eruptive breakdown (PEB).
- Permanent molars with caries lesions classified as ICDAS 3 or higher.
- Enamel defects of other etiologies in permanent molars (e.g., Amelogenesis Imperfecta, fluorosis, or hypoplasia).
- Patients with systemic diseases or lack of cooperation during dental treatment
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 Infiltrant (Icon®, DMG)Application of a low-viscosity light-cured resin (Icon®) after surface pretreatment with 15% hydrochloric acid gel (Icon-Etch). The resin is applied to the affected permanent molar to seal the porous enamel and prevent post-eruptive breakdown. | Other | Resin Infiltrant (Icon®) |
| Varnish-Modified Glass Ionomer (Clinpro XT®, 3M)Application of a site-specific, light-cured varnish-modified glass ionomer (Clinpro XT®). It provides a physical barrier and long-term fluoride release to strengthen the hypomineralized enamel. | Other | Ionomer-Based Fluoride Varnish (Clinpro XT®) |
Primary outcome
Post-eruptive breakdown (PEB)
Time frame: 6 months
The primary outcome is the occurrence of Post-Eruptive Breakdown (PEB), defined as the loss of enamel structural integrity resulting in cavitation or a clinical 'step-off' appearance within the hypomineralized area of the permanent molar. This will be recorded as a dichotomous variable (Presence/Absence) based on the European Academy of Paediatric Dentistry (EAPD) diagnostic criteria.
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 4 Mar 2026.
- Background: PubMed 33385533Nogueira VKC, Mendes Soares IP, Fragelli CMB, Boldieri T, Manton DJ, Bussaneli DG, Cordeiro RCL. Structural integrity of MIH-affected teeth after treatment with fluoride varnish or resin infiltration: An 18-Month randomized clinical trial. J Dent. 2021 Feb;105:103570. doi: 10.1016/j.jdent.2020.103570. Epub 2020 Dec 29.
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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 Resin Infiltrant (Icon®, DMG) and Varnish-Modified Glass Ionomer (Clinpro XT®, 3M) in people with Molar Hypomineralization, Incisor, run by Universidad Autonoma de San Luis Potosí at 1 site in Mexico.
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 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: finished, as of the sponsor's last update on 4 Mar 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 Mexico. 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?
Post-eruptive breakdown (PEB) (time frame: 6 months). 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 NCT07443878, which also lists 1 linked publication.
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 4 Mar 2026.