Comparing different agents for treating Molar Incisor Hypomineralization in children
Randomized Clinical Trial to Evaluate the Effectiveness of Three Remineralizing Agents on Mineral Density in Permanent Teeth and Molars With Molar Incisor Hypomineralization
NA · Universidad Nacional Autonoma de Mexico · NCT06362681
This study is testing different treatments to see which one works best for fixing tooth defects in children aged 6 to 12 with Molar Incisor Hypomineralization.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 6 Years to 12 Years |
| Sex | All |
| Sponsor | Universidad Nacional Autonoma de Mexico (other) |
| Locations | 1 site (San Pedro Apatlaco, Morelos) |
| Trial ID | NCT06362681 on ClinicalTrials.gov |
What this trial studies
This study evaluates the long-term effectiveness of various remineralization agents, including fluoride varnish and CPP-ACP pastes, on treating Molar Incisor Hypomineralization (MIH) defects in children aged 6-12 years. A total of 208 teeth with creamy-white and yellow-brown defects will be assessed over a 24-month period. Participants will be randomly assigned to different treatment groups, including a control group that receives only oral hygiene motivation. The effectiveness of the treatments will be measured using the ICDAS criteria and laser fluorescence methods.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 6 to 12 years with mild to moderate Molar Incisor Hypomineralization defects.
Not a fit: Patients with severe Molar Incisor Hypomineralization or other dental conditions such as dental fluorosis or syndromic defects may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective treatment options for children with Molar Incisor Hypomineralization, improving their dental health and quality of life.
How similar studies have performed: Other studies have shown varying degrees of success with remineralization agents, but this specific comparative approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children between 6 to 12 years * They live in the selected study area * Have at least one permanent incisor or molar with mild or moderate MIH (creamy white and/or yellow or brown opacities) * That their parents authorize participation in the study through informed consent. * No proven or suspected allergy and/or sensitivity to milk protein, as it is a component of the CPP-ACP product. Exclusion Criteria: * Defects in enamel development related to syndromes, dental fluorosis, amelogenesis imperfecta, dentinogenesis imperfecta. * Presence of orthodontic appliances. * Teeth with MIH with restorations, or severe MIH (affected enamel develops post-eruptive enamel breakdown), or carious lesions classified as score \>0 according to the ICDAS. * Children who do not show cooperation in the use of remineralizing agents.
Where this trial is running
San Pedro Apatlaco, Morelos
- Alvaro Garcia Pérez — San Pedro Apatlaco, Morelos, Mexico (RECRUITING)
Study contacts
- Principal investigator: Alvaro Garcia Pérez, PhD — Universidad Nacional Autonoma de Mexico
- Study coordinator: Alvaro Garcia Pérez, PhD
- Email: alvaro.garcia@unam.mx
- Phone: +525525351374
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.
Conditions: Molar Incisor Hypomineralization