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


METHODS
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.


METHODS
On completion, 50 subjects who received > 50 Gy of radiation to the head and neck.


METHODS
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.
Papas
A
A
Tufts University School of Dental Medicine, Boston, USA. apapas@infonet.tufts.edu
Russell
D
D
Singh
M
M
Stack
K
K
Kent
R
R
Triol
C
C
Winston
A
A
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D002130:Calcium Phosphates / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D016371:Cranial Irradiation / Q000009:adverse effects*; D004245:DMF Index; D003731:Dental Caries / Q000209:etiology / Q000517:prevention & control*; D004311:Double-Blind Method; D005260:Female; D005459:Fluorides / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D017213:Root Caries / Q000209:etiology / Q000517:prevention & control; D012463:Saliva / Q000378:metabolism; D012636:Secretory Rate / Q000528:radiation effects; D018709:Statistics, Nonparametric; D014089:Tooth Remineralization / Q000379:methods*; D014100:Toothpastes / Q000627:therapeutic use*
D002130:Calcium Phosphates; C118793:Enamelon; D014100:Toothpastes; D005459:Fluorides