Nano-hydroxyapatite toothpaste to improve color and reduce sensitivity in MIH-affected teeth
Color Change and Desensitization of Molar Incisor Hypomineralization-Affected Enamel Using Biomimetic Nano-Hydroxyapatite Toothpaste
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 6 Years to 12 Years |
| Sex | All |
| Sponsor | King Abdulaziz University Academic / other |
| Locations | 1 site (Jeddah) |
| Trial ID | NCT07436039 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Jeddah
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.