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

NCT07436039 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-02-27

No results posted yet for this study

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 .

Conditions

  • Molar-Incisor Hypomineralization (MIH)

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.

Sponsors & Collaborators

  • King Abdulaziz University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2027-06-01
Completion
2027-07-01

Countries

  • Saudi Arabia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07436039 on ClinicalTrials.gov