Use of a Glass Ionomer Sealant in Molar Incisor Hypomineralization
Launched by IRCCS BURLO GAROFOLO · Mar 28, 2023
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the use of a special type of dental sealant called glass ionomer sealant for children with a condition known as Molar Incisor Hypomineralization (MIH). MIH affects the enamel, which is the hard outer layer of teeth, making them more vulnerable to issues like cavities and sensitivity. The researchers want to see how well this glass ionomer sealant works in protecting the affected teeth over a period of 12 months.
To participate, children must be between 6 and 10 years old and have specific teeth (first permanent molars) that have erupted and show signs of MIH. They should be generally healthy and able to cooperate during the dental procedure. Parents or guardians will need to sign consent forms for their children to join the study. Participants can expect regular check-ups to monitor how well the sealant holds up and if it helps improve their dental health. This trial aims to provide more information about the best ways to treat and manage MIH in young patients.
Gender
ALL
Eligibility 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.
About Irccs Burlo Garofolo
IRCCS Burlo Garofolo is a prestigious research institute located in Trieste, Italy, dedicated to advancing pediatric healthcare through innovative clinical research. As a recognized IRCCS (Istituto di Ricovero e Cura a Carattere Scientifico), it focuses on a wide range of pediatric diseases, emphasizing the integration of clinical care and scientific research to improve patient outcomes. The institute collaborates with various national and international partners, fostering an environment of rigorous scientific inquiry and excellence in medical practice. Its commitment to ethical standards and patient safety ensures that all clinical trials conducted under its auspices contribute meaningful advancements in pediatric medicine.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Trieste, , Italy
Patients applied
Trial Officials
Milena Cadenaro, MD
Study Director
IRCCS materno infantile Burlo Garofolo
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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