Purpose: White spot lesions (WSLs) are a common complication of orthodontic therapy. It has been proposed that treatment with casein phosphopeptide-amorphous calcium phosphate, the active ingredient in MI TM products can effectively reduce the appearance of WSLs.
The aim of this study was to investigate the effect of quarterly in-office applications of MI Varnish in combination with daily at-home application of MI Paste Plus on the prevention and regression of WSLs as compared to the use 1,100 ppm fluoride toothpaste and recommendation of fluoride mouth-rinse in orthodontic patients in a 12-month, randomized, single-blind, prospective, standard-of-care controlled clinical trial.
Methods: Forty subjects at least 11 years of age and undergoing therapy with full fixed orthodontic appliances were recruited from the UCSF Orthodontics Clinic. Subjects had at least two active WSLs on the maxillary and mandibular anterior teeth at baseline. Subjects were randomly assigned to experimental or control groups. The facial surfaces of anterior teeth were evaluated at baseline, 3, 6, and 12 months using the Enamel Decalcification Index, the International Caries Detection and Assessment System and the Nyvad criteria for caries lesion activity.
Data from the final time point will be collected after the submission of this thesis. In order to avoid unblinding the study investigators to subject group assignment, data collected over the first 6 months of the study will be presented here on the entire group of subjects as a collective.
Results: There was no difference in the number of 0s, 1s, 2s, and 3s scored for tooth surfaces in the EDI or ICDAS indices from baseline to 3 months to 6 months. There was no change in average EDI sums across time or average highest ICDAS scores across time. Gingival surfaces received higher WSL scores than mesial and distal surface scores, and occlusal surfaces scored virtually zero. Salivary fluoride levels increased significantly and plaque levels decreased significantly over time.
Conclusions: Gingival surfaces experienced greater surface coverage of WSLs and higher severity of demineralization. Plaque levels improved across subjects with quarterly oral hygiene reinforcement. Salivary fluoride levels increased over time across all subjects receiving topical fluoride.