MI Varnish and MI Paste Plus in a caries prevention and remineralization study: a randomized controlled trial
White spot lesions (WSLs) are a complication of orthodontic therapy. This study investigated the effect of MI (minimally invasive) Paste Plus (MIPP) and MI Varnish (MIV) on WSLs in orthodontic patients during a 12-month, randomized, single-blind, prospective, standard-of-care controlled clinical trial.
Materials and methods
Forty subjects, recruited from the UCSF School of Dentistry Orthodontics Clinic, were randomly assigned to the experimental (twice-daily 1100 ppm fluoride toothpaste, daily MIPP, quarterly MIV application) or control group (twice-daily 1100 ppm fluoride toothpaste, fluoride rinse recommendation). Facial surfaces of incisors, canines, and first bicuspids were evaluated at baseline, 3, 6, and 12 months using the enamel decalcification index (EDI) and the international caries detection and assessment system (ICDAS).
Findings from 37 subjects are reported. At 12 months, teeth receiving experimental treatment were at lower but not significantly different odds of increased EDI scores (odds ratio, OR 0.63; intra-patient cluster-adjusted 95% CI 0.43, 1.18) and not associated with increased ICDAS scores (OR 0.99; 95% CI 0.64, 1.54). There was no statistically significant difference in mean patient-level EDI sum (experimental group 40.2; control 41.3; t test p = 0.80), ICDAS score (experimental 22.3; control 22.6; Mann-Whitney U test p = 0.80), or percentage of scored surfaces with ICDAS > 0 (experimental 54.6%; control 55.2%; t test p = 0.88). Salivary fluoride levels were significantly higher at 12 months for the experimental than for the control group (0.20 ± 0.26 versus 0.04 ± 0.04 ppm, Mann-Whitney U test p < 0.01).
Applying daily MIPP and quarterly MIV resulted in no statistically significant differences in EDI sum and ICDAS scores. Higher salivary fluoride levels in the experimental group suggest that MIPP and MIV effectively deliver fluoride when used clinically.
Daily MIPP and quarterly MIV applications do not appear to reduce significantly WSLs incidence during fixed orthodontic treatment.
KeywordsOrthodontic brackets White spot lesions Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) MI Paste Plus MI Varnish Randomized controlled single-blind prospective clinical trial Salivary fluoride level
Thanks to Karina Lee and Anupama Sharma, UCSF School of Dentistry Class of 2016 for verifying data transfers into digital spreadsheets. Gerald Nelson, UCSF Division of Orthodontics, is gratefully acknowledged for consulting with clinical questions. The authors thank Marcia Rapozo-Hilo for performing the salivary fluoride assays.
Consent to submit the manuscript and contribution
Consent to submit has been received explicitly from all coauthors. All authors have contributed sufficiently to the scientific work and therefore share collective responsibility and accountability for the results.
This work is a Principal Investigator Initiated Study and was funded by GC America, Inc. (Alsip, IL) through the University of California, San Francisco’s Contracts & Grants Division.
Compliance with ethical standards
UCSF Institutional Review Board (IRB) approval was obtained (IRB #13-10710) and the study was registered with the US National Institute of Health as a Phase 4 clinical trial (ClinicalTrials.gov Identifier: NCT02424097).
Conflict of interest
The authors declare that they have no conflict of interest.
All procedures performed in this study involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.
Informed consent was obtained from all individual participants included in the study.
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