A Clinical Trial Measuring White Spot Lesion Progression and Regression

Objectives: A clinical trial to investigate the progression/regression of white spot lesions (WSL) in post-orthodontic adolescent subjects utilizing ICDAS II criteria for assessment of lesion severity and activity.

Methods: Eligible subjects exhibiting at least 2 WSL on buccal surfaces of anterior teeth were recruited within seven days of orthodontic bracket removal. In the 45 subjects (age 12-18 years) recruited, 408 WSL (mean 9 WSL per subject) were recorded. Subjects were randomised to either intervention group (Tooth Mousse^TM) or control group (placebo cream). Subjects were instructed to apply study product at home twice daily for 12 weeks. Clinical assessments were undertaken by three calibrated examiners at baseline, 4, 8 and 12 weeks. After prophylaxis and inspection of both wet and air-dried surfaces, WSL were scored for lesion severity and activity using ICDAS II criteria. To assess efficacy, a transition matrix incorporating both ICDAS II severity and activity criteria was used to assess transitions between baseline and follow-up examination scores. Transitions were coded as progressing (positive score), regressing (negative score) or stable (score zero). Impossible or implausible transitions were excluded from the calculation.

The transition scores were analysed using a proportional odds ordinal logistic regression model and robust variance estimates to account for clustering of lesions within subjects.

Results: Lesion severity was scored as Code 1 in 7.8%, Code 2 in 89.7% and Code 3 in 2.5% of WSL. 86.3% of WSL were classified as active. For codes 2 and 3, 31% more of these lesions had regressed with Tooth Mousse^TM than with the placebo control at 12 weeks (OR=2.3, P=0.04). Differences in the regression rates between the two treatments were not statistically significant at 4 and 8 weeks.

Conclusions: ICDAS II criteria and transition scoring provided a useful method to demonstrate that significantly more post-orthodontic WSL regressed with Tooth Mousse^TM compared to a placebo control.

Study Sponsor: CRC for Oral Health Science/GC Corporation, Japan