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

NCT06362681 | Recruiting DMC

• 1 other identifier: CF-2023-I-13
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Molar Incisor Hypomineralization

Keywords

Molar Incisor Hypomineralization

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Group I: control (oral hygiene motivation only),

NO INTERVENTION

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.

Group II: fluoride varnish (Flúor Protector Ivoclar Vivadent)

EXPERIMENTAL

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

Group III: fluoride varnish (Clinpro White Varnish 3M ESPE)

EXPERIMENTAL

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

Group IV: CPP-ACP

EXPERIMENTAL

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

Interventions

Fluoride OTHER

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

Also known as: Casein phosphopeptide-amorphous calcium phosphate, Fluor protector, Clinpro White Varnish

Group II: fluoride varnish (Flúor Protector Ivoclar Vivadent); Group III: fluoride varnish (Clinpro White Varnish 3M ESPE); Group IV: CPP-ACP

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Nacional Autonoma de Mexico: lead

Study Sites (1)

Alvaro Garcia Pérez

San Pedro Apatlaco, Morelos, Mexico

RECRUITING

MeSH Terms

Conditions

Molar Hypomineralization

Interventions

Fluorides; casein phosphopeptide-amorphous calcium phosphate nanocomplex; Fluor Protector

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Anions; Ions; Electrolytes; Inorganic Chemicals; Hydrofluoric Acid; Fluorine Compounds

Study Officials

• Alvaro Garcia Pérez, PhD

  Universidad Nacional Autonoma de Mexico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alvaro Garcia Pérez, PhD

CONTACT

+525525351374; alvaro.garcia@unam.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: 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.

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 12, 2024
• Study Start: March 1, 2024
• Primary Completion: June 30, 2024
• Study Completion: March 30, 2026
• Last Updated: April 12, 2024

Record last verified: 2024-04

Locations

ME (1)