Design. A prospective randomized, double-blind, placebo-controlled, cr
oss-over clinical trial. Setting. A university hospital. Subjects. Twe
nty-one patients with symptomatic recurrent aphtous stomatitis (RAS),
unresponsive to conventional treatment were enrolled. They were divide
d into three groups. Intervention. In a cross-over trial, the patients
received an oral suspension of sucralfate, an antacid solution or a p
lacebo for 2 years. Results. After 2 years of follow-up, sucralfate wa
s found to be superior to both placebo and antacid (P < 0.001) with re
gard to duration of pain, reduction of the healing period, response ti
me to first treatment and duration of remission. Conclusion. Sucralfat
e suspension should be added to the armament of treatment modalities o
f RAS.