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Study identifier: NCT07244991 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Dental Caries · Streptococcus Mutans · Tooth Demineralization  ·  Sponsor: Cardenal Herrera University

PhaseNA
Planned participants200
Who can joinAll sexes, 5 Years to 45 Years
Healthy volunteersYes

About this study

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 appliances, progression occurs after at least six months. Increased S. mutans levels have been reported as early as six weeks after treatment start. Risk factors include poor brushing, lack of floss or rinse use, time since last cleaning, and presence of caries or lesions. Intervention MI Paste Plus (GC, Japan) is a remineralizing cream with 0.20% sodium fluoride (900 ppm) and 10% CPP-ACP (RECALDENT™), providing calcium and phosphate stabilized by casein phosphopeptides. It has antibacterial and remineralizing effects, suitable during or after orthodontic treatment to prevent or reduce WSLs. …

This description comes directly from the study's public registry record.

Talk to the study team

Santiago Arias de Luxán, DMD, PhD  ·  +34 961 369 000  ·  santiago.arias@uchceu.es

Shirli Kelmendi, DMD  ·  +355697721263  ·  shirli.kelmendi@alumnos.uchceu.es

Always discuss trial participation with your own doctor first.

Locations (2)

Beaty DentTirana, Albania, AlbaniaRecruiting
Happy DentTirana, Albania, AlbaniaNot Yet Recruiting

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Source record: clinicaltrials.gov/study/NCT07244991