Caries clinical trial of a remineralising toothpaste in radiation patients.

Abstract

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.

• Authors: Athena Papas, David Russell, Mabi Singh, Ralph Kent, Cal Triol, Anthony Winston
• Journal: Gerodontology (Gerodontology) Vol. 25 Issue 2 Pg. 76-88 (Jun 2008) ISSN: 0734-0664 [Print] England
• PMID: 18485139 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Calcium Phosphates
• Cariostatic Agents
• Enamelon
• Toothpastes
• amorphous calcium phosphate
• Fluorides

Topics

• Adult
• Aged
• Aged, 80 and over
• Calcium Phosphates (therapeutic use)
• Cariostatic Agents (therapeutic use)
• Cranial Irradiation (adverse effects)
• Dental Caries (drug therapy, etiology)
• Double-Blind Method
• Female
• Fluorides (therapeutic use)
• Head and Neck Neoplasms (radiotherapy)
• Humans
• Jaw Diseases (complications, etiology)
• Male
• Middle Aged
• Osteoradionecrosis (complications, etiology)
• Tooth Remineralization (methods)
• Toothpastes (chemistry, therapeutic use)
• Xerostomia (complications, etiology)