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

Randomized Clinical Trial to Evaluate the Effectiveness of Three Remineralizing Agents on Mineral Density in Permanent Teeth and Molars With Molar Incisor Hypomineralization

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06362681
Enrollment
100
Registered
2024-04-12
Start date
2024-03-01
Completion date
2026-03-30
Last updated
2024-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Molar Incisor Hypomineralization

Keywords

Molar Incisor Hypomineralization

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.

Interventions

OTHERFluoride

Application of remineralizing agents on teeth and molars with MIH during 24 months of follow-up.

Sponsors

Universidad Nacional Autonoma de Mexico
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

using a block randomization technique in which a computer-generated sequence would be used to assign each participant to a particular group in the allocation ratio of 1:1.

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.

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Mineral Density24 monthsevaluate and compare variations in mineral density (MD) using laser induced fluorescence (LF) after applying Fluoride Varnish, Clinpro or Casein phosphopeptide amorphous calcium phosphate on teeth with Molar Incisor Hypomineralization (MIH).

Countries

Mexico

Contacts

Primary ContactAlvaro Garcia Pérez, PhD
alvaro.garcia@unam.mx+525525351374

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026