The effect of a dentifrice in the prevention of recurrent aphthous stomatitis.
OBJECTIVE
A multicenter, double-blind, randomized, placebo-controlled clinical trial was conducted to determine the efficacy of an experimental dentifrice on the prevention of recurrent aphthous stomatitis (RAS).


METHODS
A 3-month pretrial period was used to self-record data pertaining to the frequency, ulcer size, duration, and pain associated with ulcers. Thirty-six participants, who reported at least 3 RAS episodes or 30 days with RAS during the pretrial period, completed the study. Following a stratified randomization for age, sex and disease severity, the participants received the experimental dentifrice (T) or the placebo (C). The test period comprised 3 months of self-evaluation of number of ulcers, size and location. Pain related to RAS was estimated by the use of a Visual Analogue Scale (VAS).


RESULTS
Symptoms were found to decrease in both groups when the pretrial and test periods were compared, although no statistical difference was reached in the C group. A statistically significant difference between the two time periods was obtained for the T group concerning the number of days with ulcers (p < 0.025) and VAS (p < 0.010). Of more clinical importance was the observation that 50% of the patients in the T group reported a more than 50% reduction in days with ulcers compared to 17% in the C group.


CONCLUSIONS
The dentifrice may be used as a treatment strategy for a subgroup of patients with RAS in view of the low adverse effects and the benefit of using a treatment modality that is a part of daily routines.
Coli
Pierluigi
P
Department of Prosthetic Dentistry/Dental Materials Science, Faculty of Odontology, Göteborg University, Göteborg, Sweden.
Jontell
Mats
M
Hakeberg
Magnus
M
D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D003802:Dentifrices / Q000032:analysis / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D010919:Placebos; D013281:Stomatitis, Aphthous / Q000473:pathology / Q000503:physiopathology / Q000517:prevention & control*; D013997:Time Factors
D003802:Dentifrices; D010919:Placebos