Double-blind, randomized, controlled clinical trial of the effects of diosmectite and basic fibroblast growth factor paste on the treatment of minor recurrent aphthous stomatitis.

OBJECTIVE

This study investigated the effectiveness and safety of topical application of diosmectite (DS) and basic fibroblast growth factor (bFGF) paste in the treatment of minor recurrent aphthous stomatitis.

STUDY

DESIGN

Four pastes, containing bFGF and DS, DS alone, bFGF alone, and vehicle only, were consecutively applied 4 times per day for 5 days. Pain levels and the amount of ulcer amelioration were evaluated.

RESULTS

A total of 129 participants completed the study. DS+bFGF paste released bFGF continuously and significantly lowered ulcer pain scores (P < .05 for days 3, 4, 5, and 6) compared with the other pastes. The ulcer size was significantly reduced (P < .05 for days 2, 4, and 6) in the DS+bFGF paste group compared with the other groups. No obvious adverse drug effects were observed.

CONCLUSIONS

DS+bFGF paste was effective in alleviating ulcer pain and promoting healing without significant side effects in the treatment of minor recurrent aphthous stomatitis.