Effects of Different Remineralization Agents on Molar Incisor Hypomineralization Defects: a Randomized Clinical Study
NCT ID: NCT06362681
Last Updated: 2024-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2024-03-01
2026-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
QUADRUPLE
Study Groups
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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.
No interventions assigned to this group
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.
Fluoride
Application of remineralizing agents on teeth and molars with MIH during 24 months of follow-up.
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.
Fluoride
Application of remineralizing agents on teeth and molars with MIH during 24 months of follow-up.
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.
Fluoride
Application of remineralizing agents on teeth and molars with MIH during 24 months of follow-up.
Interventions
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Fluoride
Application of remineralizing agents on teeth and molars with MIH during 24 months of follow-up.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
6 Years
12 Years
ALL
Yes
Sponsors
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Universidad Nacional Autonoma de Mexico
OTHER
Responsible Party
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Alvaro García Perez
Dr.
Principal Investigators
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Alvaro Garcia Pérez, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidad Nacional Autonoma de Mexico
Locations
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Alvaro Garcia Pérez
San Pedro Apatlaco, Morelos, Mexico
Countries
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Central Contacts
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Other Identifiers
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CF-2023-I-13
Identifier Type: -
Identifier Source: org_study_id
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