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

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: Pentoxifylline (also known as oxpentifylline)

Primary Measures

• Reduction in the median pain score
• Reduction in the median ulcer size
• Reduction in the median ulcer number
• Reduction in the total number of episodes of ulceration (RAS)

Secondary Measures

• Change in global ulcer severity score
• Increase in the proportion of ulcer free days
• Difference in the proportion of ulcer free days (comparing trial v baseline)
• Side effect incidence
• Side effect type

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 16 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Central Manchester and Manchester Children's University hospitals NHS Trust

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00315679

Study ID Number: MHT01

ClinicalTrials.gov Identifier: NCT00315679

Health Authority: United Kingdom: National Health Service