Caries clinical trial of a remineralising toothpaste in radiation patients.
OBJECTIVE
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.


METHODS
The study compared the performance of the remineralising toothpaste with a conventional fluoride dentifrice using double-blind randomisation.


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.


METHODS
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.


METHODS
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.


CONCLUSIONS
The results indicate that the remineralising toothpaste provides a significant benefit in preventing and remineralising root caries in high-risk patients.
Papas
Athena
A
Tufts University School of Dental Medicine, Boston, MA, USA. athena.papas@tufts.edu
Russell
David
D
Singh
Mabi
M
Kent
Ralph
R
Triol
Cal
C
Winston
Anthony
A
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002130:Calcium Phosphates / Q000627:therapeutic use*; D002327:Cariostatic Agents / Q000627:therapeutic use*; D016371:Cranial Irradiation / Q000009:adverse effects*; D003731:Dental Caries / Q000188:drug therapy* / Q000209:etiology; D004311:Double-Blind Method; D005260:Female; D005459:Fluorides / Q000627:therapeutic use*; D006258:Head and Neck Neoplasms / Q000532:radiotherapy; D006801:Humans; D007571:Jaw Diseases / Q000150:complications* / Q000209:etiology; D008297:Male; D008875:Middle Aged; D010025:Osteoradionecrosis / Q000150:complications* / Q000209:etiology; D014089:Tooth Remineralization / Q000379:methods*; D014100:Toothpastes / Q000737:chemistry / Q000627:therapeutic use*; D014987:Xerostomia / Q000150:complications / Q000209:etiology
D002130:Calcium Phosphates; D002327:Cariostatic Agents; C118793:Enamelon; D014100:Toothpastes; C519480:amorphous calcium phosphate; D005459:Fluorides