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Effect of Enamel Cleaning on a Remineralizing Paste for Hypomineralizated Lesions

NCT07653373 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2026-07-08

No results posted yet for this study

Summary

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.

Conditions

  • Molar Incisor Hypomineralization

Interventions

DRUG

Sodium hypochlorite 5.25%

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

DRUG

CPP-ACPF

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.

Sponsors & Collaborators

  • Fundação de Amparo à Pesquisa e Desenvolvimento Científico do Maranhão

    collaborator OTHER

  • Universidade Ceuma

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2027-12-31
Completion
2028-04-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07653373 on ClinicalTrials.gov