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

N

National Autonomous University of Mexico ( UNAM )

Status

Enrolling

Conditions

Molar Incisor Hypomineralization

Treatments

Other: Fluoride

Study type

Interventional

Funder types

Other

Identifiers

NCT06362681
CF-2023-I-13

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

6 to 12 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Quadruple Blind

100 participants in 4 patient groups

Group I: control (oral hygiene motivation only),
No Intervention group
Description:
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 group
Description:
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.
Treatment:
Other: Fluoride
Group III: fluoride varnish (Clinpro White Varnish 3M ESPE)
Experimental group
Description:
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.
Treatment:
Other: Fluoride
Group IV: CPP-ACP
Experimental group
Description:
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.
Treatment:
Other: Fluoride

Trial contacts and locations

1

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Central trial contact

Alvaro Garcia Pérez, PhD

Data sourced from clinicaltrials.gov

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