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.