Double blind clinical trial of a remineralizing dentifrice in the prevention of caries in a radiation therapy population

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 PRODUCTS: The products compared both contain equivalent quantities of fluoride (1150 ppm). 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.