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 .

Study Overview

• Status: Recruiting
• Conditions: Molar-Incisor Hypomineralization (MIH)
• Intervention / Treatment: Device: Fluoridated Toothpaste; Device: Nano-hydroxyapatite Toothpaste

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: sabbagh; Phone Number: +966 50 566 8481; Email: hjsabbagh@gmail.com

Study Locations

• Saudi Arabia
  • Jeddah, Saudi Arabia
    • Recruiting
    • King Abdulaziz University Hospital, Jeddah, Saudi Arabia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nano-hydroxyapatite Toothpaste Group; 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; 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.
Active Comparator: Fluoridated Toothpaste Group; Participants in this group will use fluoridated toothpaste (1450 ppm fluoride) three times daily under parental supervision for 9 months.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Color Change of Molar Incisor Hypomineralization-Affected Enamel Using Biomimetic Nano-Hydroxyapatite Toothpaste	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	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).

Collaborators and Investigators

• Sponsor: King Abdulaziz University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: November 23, 2025
• First Submitted That Met QC Criteria: February 21, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 21, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Dental Enamel Hypomineralization; Developmental Defects of Enamel; Stomatognathic Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Tooth Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Molar Hypomineralization
• Other Study ID Numbers: MIH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No