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Recruiting NCT07436039

Color Change and Desensitization of Molar Incisor Hypomineralization-Affected Enamel Using Biomimetic Nano-Hydroxyapatite Toothpaste

Trial Parameters

Condition Molar-Incisor Hypomineralization (MIH)
Sponsor King Abdulaziz University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 60
Sex ALL
Min Age 6 Years
Max Age 12 Years
Start Date 2025-10-01
Completion 2027-06-01
Interventions
Fluoridated ToothpasteNano-hydroxyapatite Toothpaste

Brief Summary

This clinical trial aims to evaluate if nano-hydroxyapatite (Nano-HA) toothpaste effectively treats children with Molar-Incisor Hypomineralization (MIH). It will also assess the safety of Nano-HA toothpaste. The main questions are: * Does Nano-HA toothpaste reduce caries incidence, improve tooth aesthetics, and decrease hypersensitivity? * How does Nano-HA compare to fluoridated toothpaste in terms of outcomes? Participants will: * Use Nano-HA or fluoridated toothpaste daily for 12 months. * Visit the clinic for checkups and evaluations every 1 to 3 months. * Record symptoms, brushing compliance, and sensitivity. The study will compare Nano-HA toothpaste to fluoridated toothpaste to determine its efficacy in managing MIH .

Eligibility Criteria

Inclusion Criteria: \- Children aged 6-12 years. * Diagnosed with Molar-Incisor Hypomineralization (MIH) in at least one first permanent molar or hypomineralization of a second primary molar (HSPM). * Presence of white, creamy, yellow, or brown demarcated opacities * Indexed teeth include permanent first molars and permanent maxillary incisors. Exclusion Criteria: * • Decayed permanent molars. * Diabetes, hypertension, sleeping disorders, or allergic reactions to medications. * Children on medication * Presence of other enamel defects (e.g., fluorosis, amelogenesis imperfecta, enamel hypoplasia, or white spot lesions). * Previous treatment with liquid enamel or other remineralizing agents on affected teeth.

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