Effect of Enamel Cleaning on a Remineralizing Paste for Hypomineralizated Lesions

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-9
SponsorUniversidade Ceuma

About this trial

Molar-incisor hypomineralization (MIH) is a qualitative defect of dental enamel, in which low mineral content and high protein content compromise the effectiveness of remineralizing treatments. Various agents have been used to remove proteins from hypomineralized enamel, such as sodium hypochlorite (NaOCl). Sodium hypochlorite is an antimicrobial irrigant capable of dissolving tissues. The amorphous calcium fluoride casein phosphate phosphopeptide (CPP-ACPF) is used as a remineralizing agent for MIH lesions, it is capable of stabilizing calcium, phosphate, and fluoride ions on the tooth surface, maintaining them in an amorphous form. Therefore, the objective of this study is to evaluate the clinical performance of CPP-ACPF dental mousse on deproteinized hypomineralized enamel.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Children with at least one permanent molar without MIH.

At least two permanent molars with mild MIH lesions (demarcated opacities without structural loss)

Lesions may be with or without sensitivity

Lesions cream-white or yellowish in color

Disqualifiers

Visible bacterial biofilm

Enamel malformations associated with syndromes

Amelogenesis imperfecta

Fluorosis

Trial design

Design model

Single group

Treatments tested in this trial

  • Sodium hypochlorite 5.25%

    Drug

    Sodium hypochlorite is a proteolytic substance that interferes with the cellular metabolism of proteins.

  • CPP-ACPF

    Drug

    Casein is a milk-derived protein that, during enzymatic digestion in the mouth, is converted into a casein phosphopeptide (CPP) molecule. CPP is capable of stabilizing calcium, phosphate, and fluoride ions on the tooth surface, keeping them in an amorphous form. Thus, CPP-ACPF functions as a reservoir of calcium phosphate.

Treatment groups

54 Participants
are divided into 3 treatment groups
Group A: Control Group (molars without hypomineralization)No intervention 0 interventions
Group B: CPP-ACPF in hypomineralized molarsExperimental treatment 1 intervention
Group C: Sodium hypochlorite 5.25%/CPP-ACPF GroupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Mineralization of MIH lesions

The measurements will be taken using a spectrophotometer (Vita Easyshade) to assess tooth brightness before and after treatment

Time frame
1 month

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidade Ceuma

Lead sponsor

Fundação de Amparo à Pesquisa e Desenvolvimento Científico do Maranhão

Collaborator

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