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RECRUITING
NCT07436039
NA

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

Sponsor: 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 .

Key Details

Gender

All

Age Range

6 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-10-01

Completion Date

2027-07-01

Last Updated

2026-02-27

Healthy Volunteers

No

Interventions

DEVICE

Fluoridated Toothpaste

Participants will use fluoridated toothpaste (1450 ppm fluoride) three times daily under parental supervision for 9 months to compare its effects with Nano-hydroxyapatite.

DEVICE

Nano-hydroxyapatite Toothpaste

Participants in this group will brush their teeth with Nano-hydroxyapatite toothpaste three times daily under parental supervision for 9 months to evaluate its impact on caries reduction, aesthetics, and sensitivity.

Locations (1)

King Abdulaziz University Hospital, Jeddah, Saudi Arabia

Jeddah, Saudi Arabia