Using a glass ionomer sealant for treating Molar Incisor Hypomineralization
Use of a Glass Ionomer Sealant in First Permanent Molars Affected by Molar Incisor Hypomineralization
This study is testing if a special sealant can help treat dental problems in kids aged 6 to 10 who have weak enamel on their first permanent molars.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15 (estimated) |
| Ages | 6 Years to 10 Years |
| Sex | All |
| Sponsor | IRCCS Burlo Garofolo Academic / other |
| Locations | 1 site (Trieste) |
| Trial ID | NCT05806398 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on Molar Incisor Hypomineralization (MIH), a developmental defect of dental enamel affecting permanent molars and incisors. It aims to evaluate the effectiveness of glass ionomer sealants on MIH-affected first permanent molars in children aged 6 to 10 years. The study will include children with erupted MIH lesions on their molars, assessing the impact of the sealant on the management of MIH-related dental issues. The research will be conducted at the IRCCS Burlo Garofolo in Trieste.
Who should consider this trial
Good fit: Ideal candidates are children aged 6 to 10 years with erupted MIH-affected first permanent molars showing lesions on the occlusal surface.
Not a fit: Patients with other enamel defects, such as fluorosis or amelogenesis imperfecta, or those with severe caries or orthodontic devices may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve dental health outcomes for children with Molar Incisor Hypomineralization by preventing further enamel damage and associated complications.
How similar studies have performed: While there is limited data on the specific use of glass ionomer sealants for MIH, similar approaches in managing dental enamel defects have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. FPMs of children aged between 6 and 10 years; 2. Erupted MIH affected FPMs presenting lesions on the occlusal surface; 3. Good general health conditions; 4. Sufficient cooperative behaviour; 5. Signature of the informed consent to the study by patients' parents or by their legal guardians Exclusion Criteria: 1. FPMs presenting fluorosis, amelogenesis imperfecta, white spots, or other enamel defects that are in differential diagnosis with MIH; 2. FPMs presenting the occlusal surface already sealed or restored; 3. FPMs presenting occlusal cavitated caries (ICDAS Pit and Fissures ≥ 3) 4. FPMs presenting severe PEB involving the dentin; 5. Children with orthodontic devices hiding FPMs.
Where this trial is running
Trieste
- IRCCS Burlo Garofolo — Trieste, Italy (Recruiting)
Study contacts
- Study coordinator: Milena Cadenaro, MD
- Email: milena.cadenaro@burlo.trieste.it
- Phone: +390403785111
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.