Molar Incisor HypomineralisationPhase 2MIH-CARENCT07177053
Hydroxyapatite vs Fluoride Toothpaste for MIH Remineralization
A Phase 2 study testing non fluoridated hydroxyapatite tooth paste (KAREX KINDER tooth paste) and fluoridated toothpaste (Colgate Total PROTECTION ACTIVE) in people with Molar Incisor Hypomineralisation, run by Dubai Health.
Trial summary
Molar Incisor Hypomineralization (MIH) is a common developmental enamel defect affecting children, particularly in Dubai, where it contributes to hypersensitivity, esthetic concerns, plaque accumulation, and increased caries risk. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Molar Incisor Hypomineralisation
- What is being tested?
- non fluoridated hydroxyapatite tooth paste (KAREX KINDER tooth paste) and fluoridated toothpaste (Colgate Total PROTECTION ACTIVE)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Nov 2025to Nov 2026
- Phase
- Phase 2
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- at least one affected permanent molar or incisor
- good general health
- parental informed consent, and the child's assent
Who cannot join
- Patients with systemic conditions affecting enamel or recent use of desensitizing treatments.
About this study
Official title: Comparative Clinical Evaluation of Remineralization of Molar Incisor Hypomineralization Using Hydroxyapatite vs. Fluoride Toothpaste
Molar Incisor Hypomineralization (MIH) is a common developmental enamel defect affecting children, particularly in Dubai, where it contributes to hypersensitivity, esthetic concerns, plaque accumulation, and increased caries risk. These complications often lead to premature tooth extraction and orthodontic issues, negatively impacting children's oral health-related quality of life.
This randomized, open-label clinical trial aims to compare the remineralization efficacy of a fluoride-free hydroxyapatite toothpaste with a conventional fluoride toothpaste in children aged 6-12 years diagnosed with mild to moderate MIH.
Read more
Participants will be recruited from Dubai Health pediatric dental clinics, with inclusion criteria requiring at least one affected permanent molar or incisor, good general health, parental informed consent, and the child's assent. Children with systemic conditions affecting enamel or recent use of desensitizing treatments will be excluded.
Primary outcome assessment will involve Quantitative Light-Induced Fluorescence-QLF at baseline, 3, 6, 9, and 12 months. The images were analyzed using a commercial software program (Inspektor QLF 1.97, Inspektor Research Systems, Amsterdam, The Netherlands) to determine the change in fluorescence (ΔF, %) and extension of the lesion (area; mm2).
Secondary outcome measures will include enamel fluorescence readings using the DIAGNOdent Pen. After prophylaxis and air-drying, three readings per lesion will be recorded, with mean and peak values analyzed to monitor mineralization. Hypersensitivity in MIH-affected teeth will be assessed using air stimulus (Schiff scale) and Visual Analogue Scale (VAS) at baseline, 3, 6, 9, and 12 months. Oral health-related quality of life (OHRQoL) will be measured using age-appropriate validated questionnaires to evaluate the impact of MIH and treatment over time.
This study also responds to growing parental concerns about fluoride exposure and the demand for safer, fluoride-free alternatives. By evaluating the clinical effectiveness of hydroxyapatite toothpaste, the trial aims to inform evidence-based preventive strategies for MIH management. The findings may guide clinical practice and public health recommendations, ultimately improving oral health outcomes for affected children.
Read the detailed description
Molar Incisor Hypomineralization (MIH) affects approximately 13-14% of children globally. It is a developmental enamel defect with multifactorial etiology, including perinatal and early childhood illnesses. Clinically, MIH leads to hypersensitivity, enamel breakdown, and increased caries risk, significantly impacting oral health-related quality of life. Remineralization strategies using fluoride and biomimetic agents like hydroxyapatite (HAP) have shown promise. HAP offers comparable efficacy to fluoride with added benefits and fewer risks.
Molar incisor hypomineralization (MIH) is a qualitative enamel defect affecting up to 14% of children globally. It is associated with enamel breakdown, hypersensitivity, and increased caries risk. Fluoride is widely used for remineralization but carries risks like fluorosis. Hydroxyapatite (HAP), a biomimetic agent, has shown comparable efficacy in caries prevention and remineralization. However, there is a lack of in vivo clinical trials comparing HAP and fluoride for MIH management in children. This study addresses the need for safer, effective alternatives to fluoride in pediatric dentistry.
- Conditions
- Molar Incisor Hypomineralisation
- Being tested
- non fluoridated hydroxyapatite tooth paste (KAREX KINDER tooth paste), fluoridated toothpaste (Colgate Total PROTECTION ACTIVE)
- Keywords
- Molar Incisor Hypomineralization (MIH), Child, Remineralization, Hydroxyapatite Toothpaste, Fluoride Toothpaste, Quantitative Light-Induced Fluorescence(QLF)
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non fluoridated hydroxyapatite tooth paste (KAREX KINDER tooth paste)Drug
arm 1 : hydroxyapatite tooth paste [ HAP] (study group): assessment will involve Quantitative Light-Induced Fluorescence- QLF at baseline, 3, 6, 9, and 12 months. The images were analyzed using a commercial software program (Inspektor QLF 1.97, Inspektor Research Systems, Amsterdam, The Netherlands) to determine the change in fluorescence
(ΔF, %) and extension of the lesion (area; mm2).
fluoridated toothpaste (Colgate Total PROTECTION ACTIVE)Drug
Arm 2 :Fluoride-containing tooth paste [1450ppm fluoride] (control group):
assessment will involve Quantitative Light-Induced Fluorescence- QLF at baseline, 3, 6, 9, and 12 months. The images were analyzed using a commercial software program (Inspektor QLF 1.97, Inspektor Research Systems, Amsterdam, The Netherlands) to determine the change in fluorescence (ΔF, %) and extension of the lesion (area; mm2).
| Study group | Role | What they receive |
|---|---|---|
| hydroxyapatite tooth paste [ HAP] (study group) | Active comparator | Not described Receives: Drug: non fluoridated hydroxyapatite tooth paste (KAREX KINDER tooth paste) |
| Fluoride-containing tooth paste [1450ppm fluoride] (control group) | Active comparator | Not described Receives: Drug: fluoridated toothpaste (Colgate Total PROTECTION ACTIVE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enamel remineralization - Fluorescence Change (ΔF, %)
Unit of measure: Percent change in fluorescence intensity (ΔF, %)
Measurement tool/method: Quantitative Light-Induced Fluorescence (QLF) imaging; images analysed with Inspektor QLF software (v1.97).
Measured: 3,6,9,12 months
Enamel remineralization - Lesion Area (mm²)
Unit of measure: Lesion surface area (mm²)
Measurement tool/method: Quantitative Light-Induced Fluorescence (QLF) imaging; images analysed with Inspektor QLF software (v1.97).
Measured: Baseline, 3, 6, 9, and 12 months.
Secondary outcomes (4)
Enamel fluorescence (adjunct)
Unit of measure: DIAGNOdent value (device units; 0-99) - numeric reading reported by the DIAGNOdent Pen (mean and peak values per lesion).
Measurement tool / method: DIAGNOdent Pen fluorescence readings (three readings per lesion after prophylaxis and air-drying; report mean and peak).
Measured: 3,6,9,12 months
Hypersensitivity- Schiff Cold Air Sensitivity Scale Score
Unit of measure: Ordinal score (0-3) per tooth
Scale description: Schiff Cold Air Sensitivity Scale; minimum = 0 (no response), maximum = 3 (severe painful response).
Interpretation: Higher scores indicate worse hypersensitivity.
Measurement tool/method: 1-second air blast (40-65 psi, 1 cm distance) applied to the affected tooth; response scored by examiner.
Measured: Baseline, 3, 6, 9, and 12 months.
Visual Analogue Scale (VAS) for Hypersensitivity
Unit of measure: Continuous score (0-10 cm)
Scale description: Visual Analogue Scale; minimum = 0 cm (no pain), maximum = 10 cm (worst imaginable pain).
Interpretation: Higher scores indicate worse hypersensitivity.
Measurement tool/method: Immediately after the air stimulus, the child self-reports hypersensitivity by marking on a 10 cm VAS line.
Measured: Baseline, 3, 6, 9, and 12 months.
Oral health-related quality of life (OHRQoL)
Unit of measure: Total CPQ score (numeric sum); change in total and domain scores from baseline.
Measurement tool/method: Child Perceptions Questionnaire (CPQ), age-appropriate validated versions (e.g., CPQ8-10, CPQ11-14), using validated Arabic translations where applicable.
Scale description:
CPQ8-10: 25 items, total score range = 0 to 100.
CPQ11-14: 37 items, total score range = 0 to 148.
Higher scores indicate worse oral health-related quality of life (more negative impact).
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study startNov 2025 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 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 HypomineralisationStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dubai Health
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Shaima Buhamer, Dubai Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07177053
- Sponsor's protocol ID
- Not yet issued
- Acronym
- MIH-CARE
- Status last verified
- Aug 2025
- First submitted
- 30 Aug 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Clinical Evaluation of Remineralization of Molar Incisor Hypomineralization Using Hydroxyapatite vs. Fluoride Toothpaste
- ClinicalTrials.gov ID
- NCT07177053
- Acronym / sponsor ID
- MIH-CARE / Not yet issued
- Conditions
- Molar Incisor Hypomineralisation
- Keywords
- Molar Incisor Hypomineralization (MIH), Child, Remineralization, Hydroxyapatite Toothpaste, Fluoride Toothpaste, Quantitative Light-Induced Fluorescence(QLF)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Dubai HealthOther government
- Study start
- Nov 2025 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 16 Sep 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.
Molar Incisor Hypomineralization (MIH) is a common developmental enamel defect affecting children, particularly in Dubai, where it contributes to hypersensitivity, esthetic concerns, plaque accumulation, and increased caries risk. These complications often lead to premature tooth extraction and orthodontic issues, negatively impacting children's oral health-related quality of life.
This randomized, open-label clinical trial aims to compare the remineralization efficacy of a fluoride-free hydroxyapatite toothpaste with a conventional fluoride toothpaste in children aged 6-12 years diagnosed with mild to moderate MIH.
Participants will be recruited from Dubai Health pediatric dental clinics, with inclusion criteria requiring at least one affected permanent molar or incisor, good general health, parental informed consent, and the child's assent. Children with systemic conditions affecting enamel or recent use of desensitizing treatments will be excluded.
Primary outcome assessment will involve Quantitative Light-Induced Fluorescence-QLF at baseline, 3, 6, 9, and 12 months. The images were analyzed using a commercial software program (Inspektor QLF 1.97, Inspektor Research Systems, Amsterdam, The Netherlands) to determine the change in fluorescence (ΔF, %) and extension of the lesion (area; mm2).
Secondary outcome measures will include enamel fluorescence readings using the DIAGNOdent Pen. After prophylaxis and air-drying, three readings per lesion will be recorded, with mean and peak values analyzed to monitor mineralization. Hypersensitivity in MIH-affected teeth will be assessed using air stimulus (Schiff scale) and Visual Analogue Scale (VAS) at baseline, 3, 6, 9, and 12 months. Oral health-related quality of life (OHRQoL) will be measured using age-appropriate validated questionnaires to evaluate the impact of MIH and treatment over time.
This study also responds to growing parental concerns about fluoride exposure and the demand for safer, fluoride-free alternatives. By evaluating the clinical effectiveness of hydroxyapatite toothpaste, the trial aims to inform evidence-based preventive strategies for MIH management. The findings may guide clinical practice and public health recommendations, ultimately improving oral health outcomes for affected children.
Detailed description
Molar Incisor Hypomineralization (MIH) affects approximately 13-14% of children globally. It is a developmental enamel defect with multifactorial etiology, including perinatal and early childhood illnesses. Clinically, MIH leads to hypersensitivity, enamel breakdown, and increased caries risk, significantly impacting oral health-related quality of life. Remineralization strategies using fluoride and biomimetic agents like hydroxyapatite (HAP) have shown promise. HAP offers comparable efficacy to fluoride with added benefits and fewer risks.
Molar incisor hypomineralization (MIH) is a qualitative enamel defect affecting up to 14% of children globally. It is associated with enamel breakdown, hypersensitivity, and increased caries risk. Fluoride is widely used for remineralization but carries risks like fluorosis. Hydroxyapatite (HAP), a biomimetic agent, has shown comparable efficacy in caries prevention and remineralization. However, there is a lack of in vivo clinical trials comparing HAP and fluoride for MIH management in children. This study addresses the need for safer, effective alternatives to fluoride in pediatric dentistry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hydroxyapatite tooth paste [ HAP] (study group) | Active comparator | Drug: non fluoridated hydroxyapatite tooth paste (KAREX KINDER tooth paste) |
| Fluoride-containing tooth paste [1450ppm fluoride] (control group) | Active comparator | Drug: fluoridated toothpaste (Colgate Total PROTECTION ACTIVE) |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- at least one affected permanent molar or incisor
- good general health
- parental informed consent, and the child's assent
Key exclusion criteria (1 listed)
- Patients with systemic conditions affecting enamel or recent use of desensitizing treatments.
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 |
|---|---|---|
| non fluoridated hydroxyapatite tooth paste (KAREX KINDER tooth paste)arm 1 : hydroxyapatite tooth paste [ HAP] (study group): assessment will involve Quantitative Light-Induced Fluorescence- QLF at baseline, 3, 6, 9, and 12 months. The images were analyzed using a commercial software program (Inspektor QLF 1.97, Inspektor Research Systems, Amsterdam, The Netherlands) to determine the change in fluorescence (ΔF, %) and extension of the lesion (area; mm2). | Drug | hydroxyapatite tooth paste [ HAP] (study group) |
| fluoridated toothpaste (Colgate Total PROTECTION ACTIVE)Arm 2 :Fluoride-containing tooth paste [1450ppm fluoride] (control group): assessment will involve Quantitative Light-Induced Fluorescence- QLF at baseline, 3, 6, 9, and 12 months. The images were analyzed using a commercial software program (Inspektor QLF 1.97, Inspektor Research Systems, Amsterdam, The Netherlands) to determine the change in fluorescence (ΔF, %) and extension of the lesion (area; mm2). | Drug | Fluoride-containing tooth paste [1450ppm fluoride] (control group) |
Primary outcome
Enamel remineralization - Fluorescence Change (ΔF, %)
Time frame: 3,6,9,12 months
Unit of measure: Percent change in fluorescence intensity (ΔF, %) Measurement tool/method: Quantitative Light-Induced Fluorescence (QLF) imaging; images analysed with Inspektor QLF software (v1.97).
Enamel remineralization - Lesion Area (mm²)
Time frame: Baseline, 3, 6, 9, and 12 months.
Unit of measure: Lesion surface area (mm²) Measurement tool/method: Quantitative Light-Induced Fluorescence (QLF) imaging; images analysed with Inspektor QLF software (v1.97).
4 secondary outcomes
Enamel fluorescence (adjunct)
Time frame: 3,6,9,12 months
Hypersensitivity- Schiff Cold Air Sensitivity Scale Score
Time frame: Baseline, 3, 6, 9, and 12 months.
Visual Analogue Scale (VAS) for Hypersensitivity
Time frame: Baseline, 3, 6, 9, and 12 months.
Oral health-related quality of life (OHRQoL)
Time frame: Baseline and 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 16 Sep 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing non fluoridated hydroxyapatite tooth paste (KAREX KINDER tooth paste) and fluoridated toothpaste (Colgate Total PROTECTION ACTIVE) in people with Molar Incisor Hypomineralisation, run by Dubai Health.
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 3 inclusion and 1 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 16 Sep 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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?
Enamel remineralization - Fluorescence Change (ΔF, %) (time frame: 3,6,9,12 months). The study lists 2 primary outcomes in all. 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 16 Sep 2025.