Original article
MI Paste Plus to prevent demineralization in orthodontic patients: A prospective randomized controlled trial

https://doi.org/10.1016/j.ajodo.2010.10.025Get rights and content

Introduction

Enamel demineralization is a problem in orthodontics. Fluoride is partially effective in addressing this problem, but additional treatment options are needed. The objective of this prospective randomized controlled trial was to determine the effectiveness of a new product, MI Paste Plus (GC America, Alsip, Ill), in the prevention or reduction of white spot lesions in orthodontic patients.

Methods

Sixty patients who were undergoing routine orthodontic treatment were recruited for this prospective randomized clinical trial. A double-blind method of randomization was used to determine whether each patient received the MI Paste Plus or a placebo paste (Tom’s of Maine, Salisbury, United Kingdom). Each patient was asked to administer the paste by using a fluoride tray for a minimum of 3 to 5 minutes each day at night after brushing. Photographic records obtained in a light-controlled environment were used to record the presence or absence of white spot lesions in both groups. The enamel decalcification index was used to determine the number of white spot lesions per surface at each time interval. Patients were followed at 4-week intervals for 3 months. A scoring system from 0 to 6 was used to determine the level of caries or cavitations. This system was also used for each tooth at each time interval.

Results

Fifty patients (26 using MI Paste Plus, 24 using the placebo paste) completed the study. The enamel decalcification index scores for all surfaces were 271 and 135 at the start of treatment and 126 and 258 at the end of treatment for the MI Paste Plus and placebo paste groups, respectively. The enamel decalcification index scores in the MI Paste Plus group reduced by 53.5%, whereas the placebo group increased by 91.1% during the study period. A 3-way analysis of variance (ANOVA) was done for the average enamel decalcification index scores. The surface type, the product/time interactions, and the product/surface interactions of the mean enamel decalcification index scores were significant (P <0.05).

Conclusions

MI Paste Plus helped prevent the development of new white spot lesions during orthodontic treatment and decreased the number of white spot lesions already present. The placebo paste had no preventive action on white spot development during orthodontic treatment; the number of lesions actually increased. MI Paste Plus reduced white spots on the gingival surfaces; the placebo paste had the opposite effect. The incisal surface effect on the mean enamel decalcification index scores over time and between products was highly significant. The incisal enamel decalcification index scores were consistently higher than those for the other surfaces (mesial, distal, and gingival).

Section snippets

Material and methods

The study protocol was reviewed and approved by the institutional review board of the University of Texas Health Science Center at Houston.

Sixty from a possible 65 patients who were undergoing routine orthodontic treatment were recruited for this prospective double-blind randomized clinical trial. The patients were 12 years of age and older. A caries risk assessment was used to determine their caries risks. They were carefully selected for the study and included and excluded on the following

Results

This study was a prospective clinical trial with a double blind method of randomization. We found that MI Paste Plus, used as presented here, not only lessened the occurrence of white spots, but also actually reduced the number of white spots already present. The results of the statistical analysis are presented in Table II, and the reduction in scores in Tables III and IV.

The subjects were recruited over a 1-year period. Sixty-five patients who expressed an interest were approached to

Discussion

White spot lesion formation is frequently encountered in orthodontic patients.4, 5, 6, 7, 8, 9 The roles of dental materials, such as glass ionomer and resin sealants, in inhibiting demineralization have been well documented and are well accepted as a standard of care. The benefit of topical fluoride in reducing demineralization and supporting remineralization is well recognized. Considerable research has been devoted to fluoride delivery methods that reduce or minimize enamel demineralization

Conclusions

The following results can be drawn from this randomized controlled trial.

  • 1.

    MI Paste Plus not only had a preventive action of white spot development during orthodontic treatment, but also decreased the number of white spot lesions.

  • 2.

    The placebo had no preventive action on white spot development during orthodontic treatment; the number of lesions actually increased.

  • 3.

    MI Paste Plus had an impact on reducing white spots on the gingival surfaces, whereas the placebo group had the opposite effect.

  • 4.

    The

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The authors report no commercial, proprietary, or financial interest in the products or companies described in this article.

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