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Effect of MI Paste Plus™ on Streptococcus Mutans and White Spot Lesions in Fixed Orthodontics

RecruitingNAAges 5 Years - 45 YearsAllCardenal Herrera University
NCT07244991 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Background This study is part of a doctoral research project at Universidad Cardenal Herrera CEU (Spain), directed by Prof. Santiago Arias de Luxán and conducted by doctoral candidate Shirli Kelmendi within the PhD program in Translational Medicine. Fixed orthodontic appliances complicate oral hygiene by creating retention areas that favor bacterial colonization and alter microbial balance. These conditions increase plaque accumulation and Streptococcus mutans (S. mutans) proliferation in saliva and plaque. The frequent low-pH environment favors aciduric bacteria such as S. mutans and lactobacilli, promoting enamel demineralization and formation of white spot lesions (WSLs) or cavitations. WSLs appear as opaque white areas due to subsurface mineral loss, mainly in the gingival third of the crown. They may develop as early as one month after bracket placement, while in patients without a

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age between 5 and 45 years. * Indication for fixed orthodontic treatment, either with fixed auxiliary appliances (including orthopedic devices) or brackets with or without auxiliary components. * General good health with no systemic diseases affecting oral health. Exclusion Criteria: * Advanced white-spot lesions with untreated dentin involvement. * Presence of active untreated dental caries at baseline. * Antibiotic therapy within the previous two months. * Previous diagnosis of molar-incisor hypomineralization (MIH). * History of immunosuppression. * Iron-deficiency anemia or other clinically relevant hematological disorders. * Parafunctional habits such as lip sucking or finger sucking. * Use of any type of dental prosthesis. * Smoking or tobacco use. * Documented allergy to nickel. * Requirement for orthodontic treatment using removable appliances or clear aligners.
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What it tests

  • MI Paste Plus (CPP-ACP with Sodium Fluoride)
  • Bioadhesive Oral Gel (Placebo)
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Where

2 sites
Beaty Dent
Tirana, Albania
Happy Dent
Tirana, Albania
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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