Clinical Performance of Giomer Preceded by Etching Versus Resin-Based Sealants Applied on Permanent Molars Affected by Molar-Incisor Hypo-mineralization
Launched by CAIRO UNIVERSITY · Apr 3, 2025
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying two types of dental sealants to see which one works better for protecting the permanent molars of children with a condition called Molar Incisor Hypomineralization (MIH). MIH causes certain teeth to have softer or discolored enamel, which can make them more sensitive and prone to cavities. The trial will compare a specific sealant called Giomer, which requires a special preparation step called etching, against a more commonly used resin-based sealant. The main goal is to find out if the Giomer sealant works just as well as the resin-based one in preventing cavities in these affected teeth.
To participate in the trial, children between the ages of 6 and 14 years must be healthy and have mild MIH, meaning they have visible changes in their tooth enamel but no severe damage. They also need to have at least one fully erupted permanent molar that is suitable for a non-invasive sealant. However, children with more serious dental issues, other health problems, or those who can't cooperate during the procedure would not be eligible. Parents will need to agree to their child's participation, and the trial is not yet actively recruiting participants. If chosen, families can expect to help contribute to important research that aims to improve dental care for children with this condition.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Healthy children aged 6-14 years who are diagnosed with mild (MIH) according to European Academy of Pediatric Dentistry (EAPD) criteria which includes demarcated enamel opacities (white, creamy, or yellow to brownish), that may induce sensitivity to external stimuli without enamel breakdown.
- • Cooperative children.
- • Presenting at least one first permanent molar (FPMs) that were fully erupted and indicated for non-invasive fissure sealant.
- • Medically fit Children (ASA I).
- Exclusion Criteria:
- • Children have hypomineralized (FPMs) with post-eruptive breakdown, cavitated and non-cavitated carious lesions, restorations, or fixed orthodontic appliances.
- • Enamel defects due to a condition other than (MIH).
- • Parents are not willing to join.
- • Molars that cannot be isolated using rubber dam.
- • Uncooperative children.
- • Medically unfit children (other than ASA I).
About Cairo University
Cairo University, a premier institution in Egypt, is dedicated to advancing medical research and education through innovative clinical trials. With a strong emphasis on improving healthcare outcomes, the university collaborates with various stakeholders to conduct rigorous scientific studies that address critical health challenges. Leveraging its extensive resources and expert faculty, Cairo University aims to contribute valuable insights to the medical community and enhance patient care both locally and globally. Through its commitment to ethical research practices and excellence, the university plays a pivotal role in shaping the future of healthcare in the region.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Cairo, , Egypt
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported