A clinical trial of the anticaries efficacy of casein derivatives complexed with calcium phosphate in patients with salivary gland dysfunction.

OBJECTIVE: The purpose of this study was to compare the caries preventive efficacy of a mouthrinse solution containing casein derivatives coupled with calcium phosphate (CD-CP) with that of a 0.05% sodium fluoride mouthrinse among individuals with dry mouth. STUDY
DESIGN: A randomized control trial design was used. Participants included individuals who had had radiotherapy for head and neck cancer (n = 82) and others with Sjögren's syndrome (n = 56). Baseline data collection was followed by reexamination 12 months later. Posterior bite-wing radiographs were taken on both occasions.
RESULTS: A total of 124 participants, 61 (49.2%) in the sodium fluoride group and 63 (50.8%) in the CD-CP group, completed the 12-month examination. The baseline characteristics of the 2 groups did not differ. Coronal caries incidence was higher in the sodium fluoride group than in the CD-CP group (34.4% and 27%, respectively), but the difference was not statistically significant. Similarly, the small difference in coronal caries increment between the 2 groups was not statistically significant (0.4 and 0.3 surfaces, respectively). There was insufficient root surface caries experience between the 2 groups observed for differences to be examined. Proportionately more of the CD-CP group lost 1 or more teeth, and the mean number of tooth loss was higher. The participants with the highest incidence and increment were those with Sjögren's syndrome in the CD-CP group. Some of that difference was accounted for by differences in baseline caries status.
CONCLUSION: It appears that CD-CP preparations hold promise as caries preventive agents for individuals with dry mouth, although confirmation of this study's findings in other settings is warranted before a definitive conclusion can be reached.

RCT Entities:   Population Interventions Outcomes