Hydroxyapatite vs Fluoride Toothpaste for MIH Remineralization

NCT07177053 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: Not yet issued
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Molar Incisor Hypomineralisation

Keywords

Molar Incisor Hypomineralization (MIH); Child; Remineralization; Hydroxyapatite Toothpaste; Fluoride Toothpaste; Quantitative Light-Induced Fluorescence(QLF)

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  Baseline, 3, 6, 9, and 12 months.

Secondary Outcomes (4)

• Enamel fluorescence (adjunct)

  3,6,9,12 months

• Hypersensitivity- Schiff Cold Air Sensitivity Scale Score

  Baseline, 3, 6, 9, and 12 months.

• Visual Analogue Scale (VAS) for Hypersensitivity

  Baseline, 3, 6, 9, and 12 months.

• Oral health-related quality of life (OHRQoL)

  Baseline and 6 months

Study Arms (2)

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)

Interventions

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).

hydroxyapatite tooth paste [ HAP] (study group)

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).

Fluoride-containing tooth paste [1450ppm fluoride] (control group)

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• at least one affected permanent molar or incisor
• good general health
• parental informed consent, and the child's assent

You may not qualify if:

• Patients with systemic conditions affecting enamel or recent use of desensitizing treatments.

Sponsors & Collaborators

• Dubai Health: lead

MeSH Terms

Conditions

Molar Hypomineralization

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Pediatric Dentist

Study Record Dates

• First Submitted: August 30, 2025
• First Posted: September 16, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-08