Evaluation of penicillin G potassium troches in the treatment of minor recurrent aphthous ulceration in a Chinese cohort: a randomized, double-blinded, placebo and no-treatment-controlled, multicenter clinical trial.
OBJECTIVE
The aim of this study was to explore the effectiveness and safety of topical application of 50 mg penicillin G potassium troches in the treatment of minor recurrent aphthous ulcerations (MiRAU) in a Chinese cohort.


METHODS
A randomized, double-blinded, placebo and no-treatment-controlled, multicenter clinical trial was performed. Troches were consecutively applied 4 times per day for 4 days. The size and pain level of ulcers were measured and recorded on days 0, 3, 4, 5, and 6.


RESULTS
A total of 258 subjects with minor recurrent aphthous ulcerations (86 subjects in penicillin G potassium group, 88 subjects in placebo control group, and 84 subjects in no-treatment control group) fulfilled the study. Penicillin G potassium significantly reduced ulcer size (P < .00001 for days 3, 4, 5, and 6) and alleviated ulcer pain (P < .00001 for days 3, 4, 5, and 6). No severe adverse reactions were observed. Only 4 subjects experienced mild adverse reaction.


CONCLUSIONS
Penicillin G potassium troches are effective in reducing ulcer size and alleviating ulcer pain of the patients in the treatment of a single episode of MiRAU in this Chinese cohort. Few adverse effects were observed with this therapeutic approach.
Zhou
Yu
Y
State Key Laboratory of Oral Disease, West China College of Stomatology, Sichuan University, Sichuan, China.
Chen
Qiaming
Q
Meng
Wenxia
W
Jiang
Lu
L
Wang
Zhi
Z
Liu
Jie
J
Lin
Mei
M
Zhou
Hongmei
H
Chen
Xiaofang
X
Zhao
Man
M
Zeng
Xin
X
D000278:Administration, Buccal; D000328:Adult; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002681:China; D015331:Cohort Studies; D004311:Double-Blind Method; D004890:Erythema / Q000139:chemically induced; D005260:Female; D005500:Follow-Up Studies; D006261:Headache / Q000139:chemically induced; D006801:Humans; D008297:Male; D010147:Pain Measurement; D010400:Penicillin G / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010919:Placebos; D012008:Recurrence; D013281:Stomatitis, Aphthous / Q000188:drug therapy* / Q000473:pathology / Q000503:physiopathology; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D010919:Placebos; D010400:Penicillin G