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A Trial of Pentoxifylline for the Treatment of Recurrent Aphthous Stomatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00315679
Recruitment Status : Completed
First Posted : April 19, 2006
Last Update Posted : August 3, 2018
Information provided by:
Manchester University NHS Foundation Trust

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

Condition or disease Intervention/treatment Phase
Recurrent Aphthous Stomatitis Drug: Pentoxifylline (also known as oxpentifylline) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : June 1996
Actual Primary Completion Date : November 1998
Actual Study Completion Date : November 1998

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Canker Sores

Primary Outcome Measures :
  1. Reduction in the median pain score
  2. Reduction in the median ulcer size
  3. Reduction in the median ulcer number
  4. Reduction in the total number of episodes of ulceration (RAS)

Secondary Outcome Measures :
  1. Change in global ulcer severity score
  2. Increase in the proportion of ulcer free days
  3. Difference in the proportion of ulcer free days (comparing trial v baseline)
  4. Side effect incidence
  5. Side effect type

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00315679

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United Kingdom
University Dental Hospital of Manchester
Manchester, United Kingdom, M15 6FH
Sponsors and Collaborators
Manchester University NHS Foundation Trust
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Principal Investigator: Martin H Thornhill, MBBS, BDS University of Sheffield School of Clinical Dentistry

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00315679    
Other Study ID Numbers: MHT01
First Posted: April 19, 2006    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018
Keywords provided by Manchester University NHS Foundation Trust:
recurrent aphthous stomatitis
recurrent mouth ulcers
clinical trial
double blind
placebo controlled
Additional relevant MeSH terms:
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Stomatitis, Aphthous
Mouth Diseases
Stomatognathic Diseases
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Vasodilator Agents
Free Radical Scavengers