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

Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010 Apr;109(4):561-6. doi: 10.1016/j.tripleo.2009.11.006. Epub 2010 Feb 26.

Abstract

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.

Material and 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.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Buccal
  • Adult
  • Anti-Bacterial Agents / administration & dosage
  • Anti-Bacterial Agents / adverse effects
  • Anti-Bacterial Agents / therapeutic use*
  • China
  • Cohort Studies
  • Double-Blind Method
  • Erythema / chemically induced
  • Female
  • Follow-Up Studies
  • Headache / chemically induced
  • Humans
  • Male
  • Pain Measurement
  • Penicillin G / administration & dosage
  • Penicillin G / adverse effects
  • Penicillin G / therapeutic use*
  • Placebos
  • Recurrence
  • Stomatitis, Aphthous / drug therapy*
  • Stomatitis, Aphthous / pathology
  • Stomatitis, Aphthous / physiopathology
  • Treatment Outcome

Substances

  • Anti-Bacterial Agents
  • Placebos
  • Penicillin G