Actively Recruiting

Phase Not Applicable
Age: 6Years - 12Years
All Genders
NCT07436039

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

Led by King Abdulaziz University · Updated on 2026-02-27

60

Participants Needed

1

Research Sites

91 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 6Years - 12Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Decayed permanent molars
  • Diabetes, hypertension, sleeping disorders, or allergic reactions to medications
  • Children on medication
  • Presence of other enamel defects such as fluorosis, amelogenesis imperfecta, enamel hypoplasia, or white spot lesions
  • Previous treatment with liquid enamel or other remineralizing agents on affected teeth

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

King Abdulaziz University Hospital, Jeddah, Saudi Arabia

Jeddah, Saudi Arabia

Actively Recruiting

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Research Team

S

sabbagh

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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