Nano-hydroxyapatite toothpaste to improve color and reduce sensitivity in MIH-affected teeth
Official title: Color Change and Desensitization of Molar Incisor Hypomineralization-Affected Enamel Using Biomimetic Nano-Hydroxyapatite Toothpaste
Run by King Abdulaziz University · NCT07436039 · Data updated 2026-11-12
This trial will test whether nano-hydroxyapatite toothpaste can improve tooth color, reduce sensitivity, and lower cavity risk in children aged 6–12 with molar-incisor hypomineralization compared with regular fluoridated toothpaste.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Years to 12 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | King Abdulaziz University Academic / other |
| Locations | 1 site (Jeddah) |
| Status | Recruiting |
| Started | October 1, 2025 |
| Main results expected | June 1, 2027 |
| Study ends | July 1, 2027 |
| Registry record updated | February 27, 2026 |
| Trial ID | NCT07436039 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 6–12 with MIH affecting at least one first permanent molar or hypomineralization of a second primary molar, showing demarcated white, creamy, yellow, or brown opacities on indexed permanent first molars and maxillary incisors, are the intended participants.
✕Probably not a fit
Children with active decay of permanent molars, other enamel defects (such as fluorosis or amelogenesis imperfecta), certain medical conditions, current medication use, or prior treatment with remineralizing agents are unlikely to benefit or may be excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Children aged 6–12 with MIH will be assigned to use either nano-hydroxyapatite toothpaste or a standard fluoridated toothpaste daily for 12 months. Participants will attend clinic visits every one to three months for clinical checks, photographs, and measurement of sensitivity, caries incidence, and tooth appearance, while caregivers record brushing compliance and symptoms. The study compares changes in tooth color, hypersensitivity scores, and new caries between the two toothpaste groups and records any adverse events. Safety and tolerability of the nano-HA toothpaste will be monitored throughout the study period.
Why it matters
Potential benefit: If successful, the nano-hydroxyapatite toothpaste could offer a simple home-based way to improve tooth appearance, reduce sensitivity, and lower cavity risk in children with MIH.
How similar studies have gone: Prior laboratory and small clinical studies indicate nano-hydroxyapatite can aid enamel remineralization and reduce sensitivity, but robust long-term pediatric evidence specifically for MIH is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
King Abdulaziz University Hospital, Jeddah, Saudi Arabia
Jeddah, Saudi Arabia Recruiting
Study contacts
- Study coordinator: sabbagh
- Email: hjsabbagh@gmail.com
- Phone: +966 50 566 8481
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.