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

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.

Study Overview

• Status: Recruiting
• Conditions: Molar Incisor Hypomineralization
• Intervention / Treatment: Other: Fluoride

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alvaro Garcia Pérez, PhD; Phone Number: +525525351374; Email: alvaro.garcia@unam.mx

Study Locations

• Mexico
  • Morelos
    • San Pedro Apatlaco, Morelos, Mexico
      • Recruiting
      • Alvaro Garcia Pérez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Group I: control (oral hygiene motivation only),; Participants will be advised to brush their teeth and enamel surfaces three times a day with a 1000 ppm fluoride toothpaste (stabilized Tin Fluoride), for which a 75ml/102g tube will be provided to each participant each time. months to ensure compliance and uniformity.
Experimental: Group II: fluoride varnish (Flúor Protector Ivoclar Vivadent); The selected participants will have the fluoride varnish applied once a month for the 24 months of the study. The varnish will only be applied to the teeth and molars with HIM.	Other: Fluoride; Application of remineralizing agents on teeth and molars with MIH during 24 months of follow-up.; Other Names: Casein phosphopeptide-amorphous calcium phosphate; Fluor protector; Clinpro White Varnish
Experimental: Group III: fluoride varnish (Clinpro White Varnish 3M ESPE); The selected participants will have the fluoride varnish applied once a month for the 24 months of the study. The varnish will only be applied to the teeth and molars with HIM.	Other: Fluoride; Application of remineralizing agents on teeth and molars with MIH during 24 months of follow-up.; Other Names: Casein phosphopeptide-amorphous calcium phosphate; Fluor protector; Clinpro White Varnish
Experimental: Group IV: CPP-ACP; Participants will make a single daily application of 0.3 g of CPP-ACP cream (GC America, MI Paste™ Recaldent®) on the enamel surface. This will be done for 24 months, at night, to maintain prolonged contact of this agent with the surface of the tooth. The night time schedule is chosen because the longer the time in which both CPP-ACP and saliva are kept in the mouth, the more effective the result will be. A measuring spoon will be given to each participant to ensure standardized delivery of 0.3 g of CPP-ACP to each participant's enamel surface.	Other: Fluoride; Application of remineralizing agents on teeth and molars with MIH during 24 months of follow-up.; Other Names: Casein phosphopeptide-amorphous calcium phosphate; Fluor protector; Clinpro White Varnish

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Universidad Nacional Autonoma de Mexico
• Investigators: Principal Investigator: Alvaro Garcia Pérez, PhD, Universidad Nacional Autonoma de Mexico

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): March 30, 2026

Study Registration Dates

• First Submitted: April 8, 2024
• First Submitted That Met QC Criteria: April 8, 2024
• First Posted (Actual): April 12, 2024

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Molar Incisor Hypomineralization
• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Tooth Abnormalities; Dental Enamel Hypomineralization; Developmental Defects of Enamel; Dental Enamel Hypoplasia; Molar Hypomineralization; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides
• Other Study ID Numbers: CF-2023-I-13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data supporting the findings of this study will be available upon request to the principal investigator of the study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No