• Caries Incidence;
  • Caries Prevention;
  • Remineralization;
  • Radiation;
  • High Risk Population;
  • Calcium;
  • Phosphate;
  • Fluoride;
  • Dentifrice


Objectives:The purpose of this study is to determine the efficacy and safety of a specially formulated remineralizing toothpaste in controlling caries in a group of high risk, head and neck radiation patients. Design:The study compares the performance of the remineralizing toothpaste with a leading conventional fluoride dentifrice using double-blind randomization. Test ProductsThe products compared both contain equivalent quantities of fluoride (1150ppm). The remineralizing toothpaste also delivers soluble calcium and phosphate ions, the essential components of teeth. Subjects:On completion, 50 subjects who received >50 Gy of radiation to the head and neck. Measurements:Examinations include coronal and root caries using the Pitts Diagnostic Criteria, salivary flow rate, plaque and gingival indices and microbiological counts over one year. Results:At this point subjects are enrolled in the study at various phases. However, the current average for the net increment per month per subject is −0.12 (±1.30) for coronal caries and 0.06 (±0.73) for root caries in subjects using the remineralizing toothpaste and 0.53 (±1.62) for coronal caries and 0.45 (±0.98) for root caries in subjects using the conventional fluoride dentifrice. Non-parametric analysis of rank scores for net root surface increments/month was statistically significant (p=0.02), suggesting lower net root surface increment/month for the remineralizing toothpaste relative to the conventional toothpaste. No significant differences were noted on coronal surfaces. Conclusions:The results to date indicate that the remineralizing toothpaste is significantly superior to the conventional fluoride dentifrice in preventing root caries in high risk patients.