Effect of MI Paste Plus™ on Streptococcus Mutans and White Spot Lesions in Fixed Orthodontics
MIPASTEORTHO
1 other identifier
interventional
200
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2026
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2025
CompletedFirst Posted
Study publicly available on registry
November 24, 2025
CompletedStudy Start
First participant enrolled
January 4, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2027
March 27, 2026
December 1, 2025
1.4 years
November 14, 2025
March 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in salivary Streptococcus mutans count (log₁₀ CFU/mL)
Stimulated saliva will be collected after ≥2 hours of fasting and oral hygiene abstention, using sterile insulin syringes to obtain 2-3 mL directly from the floor of the mouth. Samples will be refrigerated (4 °C, ≤24h), serially diluted in saline, and 1 µL plated onto TYCSB selective agar for anaerobic incubation at 37 °C for 72 hours. Colonies will be identified morphologically and confirmed with API Strep 20. S. mutans levels (CFU/mL) will be calculated from colony counts and dilution factors and expressed as log₁₀ CFU/mL. The outcome is the change in S. mutans from baseline to 1 and 3 months.
Baseline, 1 month, 3 months
Secondary Outcomes (2)
Incidence of new white-spot enamel lesions detected by ICDAS
Baseline, 1 month, 3 months
Change in ΔF (%) of white-spot lesions measured by QLF™
Baseline, 1 month, 3 months
Study Arms (2)
Experimental: MI Paste Plus
EXPERIMENTALParticipants assigned to the experimental group will apply MI Paste Plus (GC Corporation, Japan) once daily at night after toothbrushing for three months. The product contains casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) and 0.20% sodium fluoride (≈900 ppm F-). Application is performed using a clean finger or applicator, avoiding eating, drinking, or rinsing for at least 30 minutes afterward. The goal is to evaluate the preventive effect of MI Paste Plus on Streptococcus mutans levels and enamel white-spot lesions during fixed orthodontic treatment.
Placebo Comparator: Bioadhesive Gel without Active Ingredients
PLACEBO COMPARATORParticipants in the control group will use an identical-appearing bioadhesive oral gel without active ingredients, applied once daily at night after toothbrushing for three months. The gel has the same texture, color, and packaging as MI Paste Plus and serves as the placebo control. Application instructions are identical to those of the experimental group.
Interventions
Participants in the experimental arm will apply MI Paste Plus once daily at night after toothbrushing for three months. MI Paste Plus is a water-based topical dental cream containing 10% casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) and 0.20% sodium fluoride (900 ppm F-). The product is applied using a clean finger or applicator and left undisturbed for at least 30 minutes. The intervention aims to reduce Streptococcus mutans counts and prevent enamel demineralization (white-spot lesions) during fixed orthodontic treatment.
Bioadhesive oral gel without active ingredients, identical in appearance to MI Paste Plus, applied once daily for three months under the same conditions to maintain blinding.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cardenal Herrera Universitylead
- Beaty Dentcollaborator
- Institute of Public Health, Albaniacollaborator
Study Sites (2)
Beaty Dent
Tirana, Albania, 1001, Albania
Happy Dent
Tirana, Albania, 1001, Albania
Related Publications (3)
Wan AK, Seow WK, Walsh LJ, Bird PS. Comparison of five selective media for the growth and enumeration of Streptococcus mutans. Aust Dent J. 2002 Mar;47(1):21-6. doi: 10.1111/j.1834-7819.2002.tb00298.x.
PMID: 12035953BACKGROUNDMaret D, Marchal-Sixou C, Vergnes JN, Hamel O, Georgelin-Gurgel M, Van Der Sluis L, Sixou M. Effect of fixed orthodontic appliances on salivary microbial parameters at 6 months: a controlled observational study. J Appl Oral Sci. 2014 Jan-Feb;22(1):38-43. doi: 10.1590/1678-775720130318.
PMID: 24626247BACKGROUNDRobertson MA, Kau CH, English JD, Lee RP, Powers J, Nguyen JT. MI Paste Plus to prevent demineralization in orthodontic patients: a prospective randomized controlled trial. Am J Orthod Dentofacial Orthop. 2011 Nov;140(5):660-8. doi: 10.1016/j.ajodo.2010.10.025.
PMID: 22051486BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Santiago Arias de Luxán, DMD, PhD
Universidad CEU Cardenal Herrera - Facultad de Ciencias de la Salud
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The study is conducted under a triple-blind design. Participants, investigators, and outcome assessors remain unaware of group assignments. Both MI Paste Plus and placebo gels are identical in packaging, texture, and color and are supplied in coded opaque containers prepared by a dental hygienist not involved in patient evaluation or data analysis. The randomization code will be kept sealed until the completion of data collection and statistical analysis.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Orthodontics
Study Record Dates
First Submitted
November 14, 2025
First Posted
November 24, 2025
Study Start
January 4, 2026
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
November 1, 2027
Last Updated
March 27, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share
Individual participant data will not be publicly available to protect patient privacy, but de-identified data may be provided by the corresponding author upon reasonable request after publication.