A prospective randomized clinical trial into the capacity of a toothpaste containing NovaMin to prevent white spot lesions and gingivitis during orthodontic treatment

BACKGROUND: White spot lesions and gingivitis represent common, yet challenging, dilemmas for orthodontists. Fluoride has shown some benefit as a protective measure against demineralization; however, this is usually insufficient for orthodontic patients with less than ideal oral hygiene. Dentifrices containing calcium sodium phosphosilicate bioactive glass (NovaMin) have been proposed to aid in prevention of white spot lesions and gingival inflammation. Thus, the purpose of this study was to determine if the use of NovaMin reduces the formation of white spot lesions and improves gingival health in orthodontic patients. METHODS: This was a prospective, double-blind, randomized controlled trial. Forty-eight patients undergoing orthodontic treatment were randomly allocated to two groups. The control group consisted of 24 patients who received over-the-counter fluoride toothpaste (Crest®), while the study group consisted of 24 patients who were given the test dentifrice (ReNew™) containing 5 % NovaMin and fluoride. Patients were followed up for 6 months on a monthly basis. Decalcification, gingival health, plaque, and bacteria levels were evaluated every 3 months. Statistical analysis was performed using both parametric and non-parametric tests to identify differences between groups at different time points. RESULTS: There were no significant differences between the groups in regard to changes in white spot lesions, plaque, or gingival health (P > 0.05). There was a trend toward improvement in white spot lesions found in subjects using Crest® at the 3-month time point; however, this was not sustained throughout the study. CONCLUSIONS: Our results indicate that a toothpaste containing NovaMin does not differ significantly compared to traditional fluoride toothpaste for improving white spot lesions and gingivitis in orthodontic patients.