Caries clinical trial of a remineralising toothpaste in radiation patients

OBJECTIVES: The purpose of this study was to determine the efficacy and safety of a specially formulated remineralising toothpaste in controlling caries in a high-risk population: head and neck radiation patients. DESIGN: The study compared the performance of the remineralising toothpaste with a conventional fluoride dentifrice using double-blind randomisation. MATERIALS AND METHODS: Test products: The products compared contained equivalent quantities of fluoride (1100 p.p.m.). The dual-phase remineralising toothpaste, Enamelon, also delivered soluble calcium and phosphate ions, essential components of teeth, from separate phases. Both groups had all caries restored at baseline and used a fluoride rinse daily. SUBJECTS: Fifty-seven subjects who received radiation to the head and neck causing saliva hypofunction, entered the study, while 44 completed the 10-12 month visit. MEASUREMENTS: Examinations included coronal and root caries using the Pitts Diagnostic Criteria, salivary flow rate, plaque and gingival indices and microbiological counts over a 1-year period. RESULTS: The average net increment per year for root caries per subject was 0.04 (+/-.052) in subjects completing the study using the remineralising toothpaste and 1.65 (+/-0.51) for root caries in subjects completing the study using the conventional fluoride dentifrice. The difference was statistically significant (p = 0.03), suggesting lower net root surface increment/year for the remineralising toothpaste relative to the conventional toothpaste. No significant differences were noted on coronal surfaces. CONCLUSION: The results indicate that the remineralising toothpaste provides a significant benefit in preventing and remineralising root caries in high-risk patients.