A Trial of Pentoxifylline for the Treatment of Recurrent Aphthous Stomatitis

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Brief Title

A Trial of Pentoxifylline for the Treatment of Recurrent Aphthous Stomatitis

Brief Summary

      This is a randomized, double blind, placebo controlled trial of the use of pentoxifylline
      (oxpentifylline) for the treatment of recurrent mouth ulcers.

Detailed Description

      There are few effective treatments for recurrent aphthous stomatitis (cancer sores, recurrent
      mouth ulcers). Most existing treatments are palliative topical treatments. Some systemic
      drugs e.g. steroids and thalidomide can suppress the recurrence of mouth ulcers but have
      serious long term side effects. Pentoxifylline (also known as oxpentifylline) has been used
      systemically for many years to treat peripheral vascular disease and has a good side effect
      profile. It shares several actions with thalidomide but does not share its serious side
      effects. Furthermore, some small scale, open label clinical studies have indicated it may be
      very effective in treating recurrent aphthous stomatitis (RAS). This study enrolled patients
      with RAS for which no underlying cause could be identified. Patients kept a diary of the
      pattern of their mouth ulcers for 60 days to confirm the pattern of ulceration and provide
      baseline data. Those still qualified for the study were then randomized to treatment with
      pentoxifylline 400mg three times daily or an identical placebo tablet three times daily for a
      further 60 days during which they continued to keep a daily ulcer diary. At the end of this
      period, treatment was stopped and they kept the daily ulcer diary for a further 60 days to
      identify if any benefit from the treatment was continued after ceasing treatment.

Study Type


Primary Outcome

Reduction in the median pain score

Secondary Outcome

 Change in global ulcer severity score


Recurrent Aphthous Stomatitis


Pentoxifylline (also known as oxpentifylline)


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

June 1996

Completion Date

November 1998

Primary Completion Date

November 1998

Eligibility Criteria

        Inclusion Criteria:

          -  Diagnosis of minor recurrent aphthous stomatitis

          -  2 or more mouth ulcers per month for more than 6

          -  No current treatment for oral ulceration or willing to stop treatment

          -  Age 16 to 65 years

        Exclusion Criteria:

          -  Taking ketorolac, theophylline or anti-hypertensive medication except diuretics
             (contra-indicated in patients treated with pentoxifylline)

          -  Systemic diseases that contra-indicate the use of pentoxifylline i.e. pregnancy,
             hypotension, ischaemic heart disease, acute myocardial infarction, cerebral or occular
             hemorrhage, renal or hepatic failure, porphyria or allergy to pentoxifylline.

          -  Patients with an underlying deficiency state or systemic disease that could cause
             recurrent mouth ulcers e.g. iron, vitamin B12 or foliate deficience, coeliac disease,
             Crohn's disease, ulcerative colitis, Behcet's disease or Aids.




16 Years - 65 Years

Accepts Healthy Volunteers



Martin H Thornhill, MBBS, BDS, , 

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations



Organization ID


Study Sponsor

Manchester University NHS Foundation Trust

Study Sponsor

Martin H Thornhill, MBBS, BDS, Principal Investigator, University of Sheffield School of Clinical Dentistry

Verification Date

August 2018