MI Paste Plus for lowering Streptococcus mutans and preventing white spot lesions during fixed orthodontic treatment
Official title: Effect of MI Paste Plus™ on Streptococcus Mutans Counts and White Spot Lesions in Patients With Fixed Orthodontic Appliances: A Triple-Blind Clinical Trial
Run by Cardenal Herrera University · NCT07244991 · Data updated 2026-11-12
This trial will test whether daily application of MI Paste Plus reduces Streptococcus mutans levels and prevents white spot lesions in people aged 5–45 who wear fixed braces.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 5 Years to 45 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Cardenal Herrera University Academic / other |
| Locations | 2 sites (Tirana, Albania and 1 other locations) |
| Status | Recruiting |
| Started | January 4, 2026 |
| Main results expected | June 2027 |
| Study ends | November 2027 |
| Registry record updated | March 27, 2026 |
| Trial ID | NCT07244991 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are otherwise healthy people aged 5–45 who are receiving fixed orthodontic appliances and have no active untreated caries or other exclusion conditions.
✕Probably not a fit
Patients with advanced white-spot lesions involving dentin, active untreated caries, recent antibiotic use, removable-appliance treatment, tobacco use, relevant medical conditions, or allergies noted in the exclusion criteria are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Participants with fixed orthodontic appliances will be assigned to apply either MI Paste Plus (CPP-ACP with fluoride) or a bioadhesive placebo gel according to the study protocol. Investigators will collect saliva and plaque samples and will photograph and score white spot lesions at baseline and at scheduled follow-up visits to track changes over time. MI Paste Plus releases calcium, phosphate, and fluoride ions intended to promote remineralization and alter biofilm composition, while the placebo controls for gel application effects. Outcomes will compare shifts in S. mutans counts and lesion development between the groups during orthodontic treatment.
Why it matters
Potential benefit: If successful, this could reduce enamel demineralization and lower S. mutans levels in patients with braces, decreasing white spot lesions and improving long-term tooth health.
How similar studies have gone: Previous research supports that fluoride combined with CPP-ACP can enhance enamel remineralization, so MI Paste Plus has prior evidence of benefit though results specifically in fixed-appliance populations vary.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Beaty Dent
Tirana, Albania, Albania Recruiting -
Happy Dent
Tirana, Albania, Albania Not yet recruiting
Study contacts
- Principal investigator: Santiago Arias de Luxán, DMD, PhD — Universidad CEU Cardenal Herrera - Facultad de Ciencias de la Salud
- Study coordinator: Santiago Arias de Luxán, DMD, PhD
- Email: santiago.arias@uchceu.es
- Phone: +34 961 369 000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.