A comparative study of the efficacy of Aphtheal in the management of recurrent minor aphthous ulceration

J Oral Pathol Med. 2005 Aug;34(7):413-9. doi: 10.1111/j.1600-0714.2005.00334.x.


Background: Recurrent minor aphthous ulceration (RAU) is a common condition which is multifactorial in origin.

Methods: This study, firstly, aimed to treat the prodromal stage of RAU with Aphtheal (5% amlexanox paste) to determine if ulcer development could be prevented. A second arm of the study investigated treatment of RAU with Aphtheal once ulceration had developed. Ulcer duration, ulcer size and associated pain were measured. Both groups of subjects had previously undergone a no-treatment run-in period to establish these parameters over an untreated episode of ulceration.

Results: By day 3, only 35% of the prodromal group had developed an ulcer compared with 97% of the ulcer group (P < 0.001). In the treated ulcer group only 66% had an ulcer present by day 3. Treatment at the onset of prodromal symptoms reduced the maximum ulcer size score by 84% (P < 0.01), extent of ulceration by 88% (P < 0.01), maximum pain score by 69% (P < 0.01) and extent of pain by 85% (P < 0.01) compared to no treatment.

Conclusion: Treatment with Aphtheal at the onset of prodromal RAU symptoms can prevent progression to ulcer development and significantly reduced symptoms if ulcers do develop.

Publication types

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

MeSH terms

  • Adult
  • Aminopyridines / adverse effects
  • Aminopyridines / therapeutic use*
  • Anti-Allergic Agents / adverse effects
  • Anti-Allergic Agents / therapeutic use*
  • Body Temperature / drug effects
  • Erythema / drug therapy
  • Female
  • Humans
  • Male
  • Secondary Prevention
  • Stomatitis, Aphthous / drug therapy*
  • Stomatitis, Aphthous / prevention & control
  • Treatment Outcome


  • Aminopyridines
  • Anti-Allergic Agents
  • amlexanox