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

NCT07436039 | Recruiting

• 1 other identifier: MIH
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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)

Outcome Measures

Primary Outcomes (1)

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

  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.

  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

Secondary Outcomes (1)

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

  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).

Study Arms (2)

Nano-hydroxyapatite Toothpaste Group

EXPERIMENTAL

Participants in this group will use Nano-hydroxyapatite toothpaste for 9 months to assess its effect on reducing caries, improving aesthetics, and decreasing sensitivity.

Device: Nano-hydroxyapatite Toothpaste

Fluoridated Toothpaste Group

ACTIVE COMPARATOR

Participants in this group will use fluoridated toothpaste (1450 ppm fluoride) three times daily under parental supervision for 9 months.

Device: Fluoridated Toothpaste

Interventions

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.

Fluoridated Toothpaste Group

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.

Nano-hydroxyapatite Toothpaste Group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Abdulaziz University: lead

Study Sites (1)

King Abdulaziz University Hospital, Jeddah, Saudi Arabia

Jeddah, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Molar Hypomineralization

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

sabbagh

CONTACT

+966 50 566 8481; hjsabbagh@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: February 27, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)