Authors: Adam Jones, Benjamin Veale, Tiffany Li, Vishal R Aggarwal, Joshua Twigg

Interventions for the management of oral submucous fibrosis*

Review question

Which treatments are effective in improving the symptoms associated with oral submucous fibrosis?

Key messages

– The overall results are mixed but indicate that using antioxidant medications may be useful to treat restricted mouth opening and are likely to improve the burning sensation in the mouth that is experienced by people who have oral submucous fibrosis.

What is oral submucous fibrosis?

Oral submucous fibrosis is a disease that causes increasing tightness of the cheeks and mouth. People with this condition often have persistent burning mouth pain. These problems can make eating, speaking and swallowing more difficult. Many medicines have been suggested to manage this condition and may be taken by mouth (systemically), applied locally to the surface (topically) or injected directly into the affected areas. Different forms of surgery or physiotherapy are also available.

What did we want to know?

We wanted to find out which treatments are effective for improving the symptoms of oral submucous fibrosis, and which treatments are the most effective. We also wanted to know what the risks and side effects of each treatment might be and how common these are.

What did we do?

We searched databases of medical and dental journals and research trials. We only selected trials known as randomised controlled trials. In this type of trial, participants are allocated to groups randomly. One group receives the intervention and the other receives a different treatment or no treatment at all. These trials aim to reduce the risk of introducing bias in clinical trials.

We wanted to focus on how well treatments worked to allow people with oral submucous fibrosis to return to normal eating, chewing and speaking. Because no trials looked at these measures, we chose increase in mouth opening (measured in millimetres between the upper and lower front teeth) and reduction oral burning sensation (measured on a scale from 0 to 100) as the most likely measures to improve quality of life in people with oral submucous fibrosis. We looked for details of these measures immediately after treatment (up to three months), in the medium term (three to six months) and in the longer term (after six months). We also looked for information on any 'adverse effects' (negative side effects of the treatments).

What did we find?

We found 30 relevant trials. Most trials looked at different treatments that each worked differently. Many trials compared different types of treatments with each other. We decided that trials comparing one treatment against no active treatment were most important because we do not know which, if any, treatments actually work.

The results told us that antioxidant medicines (which scavenge and neutralise unstable particles that are naturally formed during metabolism or by exposure to environmental toxins) taken by mouth may improve mouth opening slightly for up to six months after treatment, but we are not sure that this lasts longer than six months. Antioxidants may also reduce burning sensation in the mouth for more than six months after treatment and we think this might be an important improvement for people with oral submucous fibrosis.

The evidence for other treatments that we looked at was very uncertain.

Only half of the trials reported side effects or other potentially harmful effects of the treatments, so it is difficult to say confidently how safe any of the treatments might be.

What are the limitations of the evidence?

We are moderately confident that antioxidants help in the treatment of oral submucous fibrosis, but have little confidence in the other evidence because many trials had design limitations.

How up to date is the search?

We searched for trials up to 5 September 2022.

*This is a plain language summary of a review that is published in the Cochrane Library. You can find the full report of the review here: https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD007156.pub3/full