Clinical trial NCT06362681: Effects of Different Remineralization Agents on Molar Incisor Hypomineralization Defects: a Randomized Clinical Study
Official title: Randomized Clinical Trial to Evaluate the Effectiveness of Three Remineralizing Agents on Mineral Density in Permanent Teeth and Molars With Molar Incisor Hypomineralization
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Molar Incisor Hypomineralization
Keywords: Molar Incisor Hypomineralization
Lead sponsor: Universidad Nacional Autonoma de Mexico
Sponsor class: OTHER
First posted: 2024-04-12
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: The children will be randomly divided into the experiment groups: control (oral hygiene motivation only), fluoride varnish, clinpro white Varnish and pastes containing CPP-ACP and followed up for 24 months.
Primary purpose: PREVENTION

Brief summary: The aim of this study was to present a comparative evaluation of the long-term efficacy of fluoride varnish( Flúor protector), Clinpro™ White Varnish and pastes containing CPP-ACP in the remineralization of creamy-white and yellow brown defects in incisors and permanent first molars with Molar Incisor Hypomineralization (MIH) in schoolchildren 6-12 years-old in Mexico.

Detailed description: The study included 208 teeth with yellow-brown or creamy-white defects in children aged 6-12 years who were newly diagnosed with MIH with no substance loss or caries or prior restorative treatment. The children will be randomly divided into the experiment groups: control (oral hygiene motivation only), fluoride varnish, clinpro white Varnish and pastes containing CPP-ACP and followed up for 24 months. The evaluations will be made based on the ICDAS criteria and the measurements which were performed using the laser fluorescence method (DIAGNOdent, KaVo, Biberach, Germany) in the follow-ups.

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.

Primary outcomes:
measure: Mineral Density
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Pedro Apatlaco
country: Mexico
facility: Alvaro Garcia Pérez
state: Morelos
Study officials:
affiliation: Universidad Nacional Autonoma de Mexico
name: Alvaro Garcia Pérez, PhD
role: PRINCIPAL_INVESTIGATOR
References: