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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Dental Caries, Streptococcus Mutans, Tooth Demineralization, Orthodontic Appliances, Fixed

In brief

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. Objective To evaluate whether MI Paste Plus during fixed orthodontic treatment reduces S. mutans counts in saliva and/or WSL incidence. Study Design A prospective, triple-blind, randomized clinical trial, approved by the Ethics Committee of the Ministry of Health of Albania and the Ethics Committee for Human Research of Universidad Cardenal Herrera CEU, Spain. The study will include 200 patients (100 per group) from two orthodontic clinics in Tirana, Albania. Participants will be stratified by age, risk level, and appliance type, then randomized by third parties. Outcome Measures Primary variables: S. mutans counts in saliva and number of WSLs after 3 months. Standardized saliva collection, culturing, and bacterial quantification ensure consistency. Clinical assessments will be performed at 1 and 3 months using QRay Cam Pro (Inspektor Systems, Netherlands) for quantitative fluorescence and ICDAS for visual inspection. Data will be analyzed using SPSS/R Commander software.

Key facts

Study ID: NCT07244991
Run by: Cardenal Herrera University
People needed: 200
Starts: 2026-01-04
Expected to finish: 2027-11-01
Last updated by the study team: 2026-03-27

Who can join

Age: 5 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Beaty Dent — Tirana, Albania, Albania (enrolling)
Happy Dent — Tirana, Albania, Albania

Full record on ClinicalTrials.gov

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