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Search / Trial NCT06362681

Effects of Different Remineralization Agents on Molar Incisor Hypomineralization Defects: a Randomized Clinical Study

Launched by UNIVERSIDAD NACIONAL AUTONOMA DE MEXICO · Apr 8, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Molar Incisor Hypomineralization

ClinConnect Summary

This clinical trial is studying how well different types of treatments can help improve the appearance and health of teeth in children with a condition called Molar Incisor Hypomineralization (MIH). MIH causes white or brown spots on the teeth, which can be concerning for both children and their parents. The researchers want to compare the effectiveness of three remineralization treatments: fluoride varnish, Clinpro™ White Varnish, and a special paste that contains milk proteins. The trial is taking place in Mexico and aims to help children aged 6 to 12 years who have at least one affected tooth.

To participate in the study, children need to be between 6 and 12 years old, live in the study area, and have mild or moderate MIH on at least one permanent tooth. Parents must agree to let their child participate, and the child must not have any allergies to milk proteins. The study will not include children with more severe dental issues or those who are not able to use the treatments properly. If eligible, participants can expect to receive one of the treatments and help researchers learn more about how to better address this dental condition in children.

Gender

ALL

Eligibility 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.

About Universidad Nacional Autonoma De Mexico

The Universidad Nacional Autónoma de México (UNAM) is a prestigious academic institution renowned for its commitment to research and innovation in the field of health sciences. As a leading sponsor of clinical trials, UNAM leverages its extensive resources and expertise to advance medical knowledge and improve patient outcomes. The university fosters interdisciplinary collaboration among its faculties, promoting rigorous scientific methodologies and ethical standards in clinical research. Through its dedication to education and public health, UNAM plays a pivotal role in addressing pressing medical challenges and contributing to the development of effective therapeutic interventions.

Locations

San Pedro Apatlaco, Morelos, Mexico

Patients applied

0 patients applied

Trial Officials

Alvaro Garcia Pérez, PhD

Principal Investigator

Universidad Nacional Autonoma de Mexico

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported