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Color Change and Desensitization of Molar Incisor Hypomineralization-Affected Enamel Using Biomimetic Nano-Hydroxyapatite Toothpaste | Clinical Trials | Clareo Health

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

NCT07436039•King Abdulaziz University

View on ClinicalTrials.gov

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

Age

6 - 12 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

King Abdulaziz University Hospital, Jeddah, Saudi Arabia

Jeddah, Saudi Arabia

Key Dates

Start Date

October 1, 2025

Primary Completion Date

June 1, 2027

Completion Date

July 1, 2027

Last Updated

February 27, 2026

Enrollment

ESTIMATED participants

Conditions

Molar-Incisor Hypomineralization (MIH)

Interventions

Fluoridated Toothpaste

DEVICE

Nano-hydroxyapatite Toothpaste

DEVICE

Contacts

sabbagh

CONTACT

+966 50 566 8481 hjsabbagh@gmail.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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