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.