Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06362681
Other study ID # CF-2023-I-13
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2024
Est. completion date March 30, 2026

Study information

Verified date April 2024
Source Universidad Nacional Autonoma de Mexico
Contact Alvaro Garcia Pérez, PhD
Phone +525525351374
Email alvaro.garcia@unam.mx
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study was to present a comparative evaluation of the long-term efficacy of fluoride varnish( Flúor protector), Clinproâ„¢ 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date March 30, 2026
Est. primary completion date June 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 12 Years
Eligibility 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.

Study Design


Intervention

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

Locations

Country Name City State
Mexico Alvaro Garcia Pérez San Pedro Apatlaco Morelos

Sponsors (1)

Lead Sponsor Collaborator
Universidad Nacional Autonoma de Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mineral Density evaluate 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). 24 months
See also
  Status Clinical Trial Phase
Completed NCT05485662 - Remineralization of Molar Incisor Hypomineralization (MIH) With a Hydroxyapatite Toothpaste N/A
Not yet recruiting NCT06342089 - Association Between Molar Incisor Hypomineralization And Type I Diabetes Milletus.
Not yet recruiting NCT06081491 - Association Between Molar-Incisor Hypomineralization, Maternal Stress and Anxiety: A Cross-Sectional Study.
Not yet recruiting NCT04410172 - Prevalence of MIH Among Group of Egyptians Children Aged From 8 to 12 in Damietta
Not yet recruiting NCT04030936 - Knowledge Regarding Diagnosis of MIH Among Dental Interns in Faculty of Dentistry Cairo University
Not yet recruiting NCT04420520 - Prevalence of Molar Incisor Hypomineralization Among a Group of Egyptian Children in Fayoum Governorate Schools
Active, not recruiting NCT05597956 - Effectiveness of Infiltration With Resin in Treatment of MIH Incisors in Children Showing Opacities N/A
Completed NCT04231019 - Knowledge of Egyptian Dental Practitioners Regarding Molar-Incisor Hypomineralization
Completed NCT03735069 - Vital Pulp Therapy in Carious Teeth With Hypomineralization N/A
Completed NCT05494749 - Zirconia Reinforced Glass Ionomer in MIH N/A
Completed NCT05931822 - Silver Diamine Fluoride Modified Restoration In Treating Hypomineralized First Permanent Molar. N/A
Not yet recruiting NCT04475419 - Restoration Quality in Molars Affected by Molar Incisor Hypo Mineralization N/A
Completed NCT04061096 - Local Anesthesia in Molar Teeth With Molar Incisor Hypomineralization N/A
Active, not recruiting NCT05748067 - Minimally Invasive Treatment for Permanent Molars Affected With Molar-incisor Hypomineralization Defects N/A
Not yet recruiting NCT03583671 - Prevalence of Molar Incisor Hypomineralization Among a Group of Egyptian Children From 8 to 12 Years Old in Dakahlia
Active, not recruiting NCT03870958 - Glass Ionomer Cement Sealant in the Prevention of Post-eruptive Fractures in Molars Affected by MIH N/A
Completed NCT05727475 - Change in OHRQOL Following Minimally Invasive Treatment of Anterior Teeth in Children With MIH N/A
Completed NCT04685889 - Resin Infiltration Treatment for MIH N/A
Not yet recruiting NCT06330272 - Accuracy of Spectrophotometry in Hypomineralized Lesions Treated With CPP-ACPF Dental Mousse: Clinical Study N/A
Enrolling by invitation NCT03233464 - Prevalence of Molar Incisor Hypomineralization Among a Group of Egyptian Children in Giza Governorate N/A