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NCT Number: NCT07436039

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

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 .

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Key information

Conditions

Molar-Incisor Hypomineralization (MIH) Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dental Enamel Hypomineralization Developmental Defects of Enamel Molar Hypomineralization Stomatognathic Diseases Stomatognathic System Abnormalities Tooth Abnormalities Tooth Diseases

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Abdulaziz University Hospital, Jeddah, Saudi Arabia

Jeddah, Saudi Arabia

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fluoridated Toothpaste

Device

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

Nano-hydroxyapatite Toothpaste

Device

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.

Primary outcomes

  1. Desensitization of Molar Incisor Hypomineralization-Affected Enamel Using Biomimetic Nano-Hydroxyapatite Toothpaste

    Time frame: Follow-up duration: 12 months. Clinical evaluations will be conducted at baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3), 9 months (T4), and 12 months (T5). The primary endpoint will be assessed at 6 months to evaluate treatment effectiveness

    Hypersensitivity can be measured using the Schiff sensitivity scale to rate patients' pain The Schiff Cold Air Sensitivity Scale is a 4-point scale used to assess dentin hypersensitivity. A score of zero indicates no sensitivity, one signifies mild sensitivity without a request to stop the stimulus, two represents moderate sensitivity with a request to stop or visible discomfort, and three indicates severe sensitivity with a request to stop and physical withdrawal.

Secondary outcomes

  1. Color Change of Molar Incisor Hypomineralization-Affected Enamel Using Biomimetic Nano-Hydroxyapatite Toothpaste

    Time frame: 12 months (Evaluations will be conducted at follow-up intervals: 1 month, 3 months, 6 months, 9 months and 12 months after the trial starts).

    The VITA Easyshade® advance spectrophotometer (VITA Zahnfabrik, Bad Sackingen, Germany) will be used to assess the color of MIH-affected permanent incisors and the adjacent sound enamel

Study contacts

Contact information is provided by the study sponsor or research team.

sabbagh

CONTACT

[email protected]

+966 50 566 8481

Sponsors and collaborators

Lead sponsor

King Abdulaziz University

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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