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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoride | Other | Application of remineralizing agents on teeth and molars with MIH during 24 months of follow-up. |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alvaro Garcia Pérez, PhD | Contact | +525525351374 | alvaro.garcia@unam.mx |
| Name | Affiliation | Role |
|---|---|---|
| Alvaro Garcia Pérez, PhD | Universidad Nacional Autonoma de Mexico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alvaro Garcia Pérez | Recruiting | San Pedro Apatlaco | Morelos | Mexico |
Data supporting the findings of this study will be available upon request to the principal investigator of the study.
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| ID | Term |
|---|---|
| D000094604 | Molar Hypomineralization |
| ID | Term |
|---|---|
| D000094603 | Dental Enamel Hypomineralization |
| D000094602 | Developmental Defects of Enamel |
| D014071 | Tooth Abnormalities |
| D018640 | Stomatognathic System Abnormalities |
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| ID | Term |
|---|---|
| D005459 | Fluorides |
| C447032 | casein phosphopeptide-amorphous calcium phosphate nanocomplex |
| C022599 | Fluor Protector |
| ID | Term |
|---|---|
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D006858 |
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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.
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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.
|
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| Hydrofluoric Acid |
| D017611 | Fluorine Compounds |