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How can we treat traumatic orthodontic ulcers? A trial that helps us!

By on December 1, 2015 in Recent posts, Research Methods with 9 Comments
How can we treat traumatic orthodontic ulcers? A trial that helps us!

How should we treat traumatic oral ulcers in orthodontic patients?

We all know what a pain traumatic orthodontic ulcers can be to our orthodontic patients.  I have always advised my patients that ulcers are a problem that will resolve in a few days.  When a patient has a major ulcer I have suggested that they try some of the topical gels, but I do not do not this routinely.  I was, therefore, very interested to see this paper that has recently been published in the advanced publication section of the open access Angle orthodontist. This paper provides us with very useful information.

a18c1c6c-4193-458a-b711-d37072b8e89b-largeEffectiveness of a novel topical powder on the treatment of traumatic oral ulcers in orthodontic patients : A randomized controlled trial.

Rennick et al. Angle Orthodontist DOI: 10.2319/050415-303.1  OPEN ACCESS

 

I thought that this was a very well written paper.  I particularly liked the introduction in which the authors outlined the cause and treatment of traumatic ulceration associated with orthodontic appliances. I was very interested to see that the incidence of traumatic ulcers ranges from 60% to 81%. Importantly, 47% of adults and 29% of children report that ulcers are one of the most annoying aspect of orthodontic treatment. It appears that most ulcers normally heal within 10 to 14 days of removing the traumatic stimulus.  Infection can prolong or delay healing and some success has been reported in reducing infection by the application of  intra oral Benzymadine hydrochloride  gels. For example, it has been shown that these gels reduce the size of ulcers by 33% but they were still not healed until the 12th day following the removal of the traumatic stimulus.

What did they do?

They carried out a study to test whether 2-DenT Oral Topical Powder accelerates healing and decreases the duration of  traumatic ulcers compared with an inactive placebo.

This was a parallel randomised controlled trial and they carried out a sample size calculation which suggested that 23 patients should be enrolled in each group. They stated they used simple random allocation which was concealed from the investigator who was assigning the patients to the study. The patient’s age ranged from 12 to 29 years.

When a patient attended the clinic with oral ulceration they were enrolled into the trial. They then removed the cause of the trauma.

The patients were shown how to apply the active or placebo gels to their ulcer. The active gel consisted of nystatin, tetracycline, metronidazole, dexamethasone, and an antihistamine. The vehicle for these agents was karaya gum which is a muco adhesive. The placebo consisted only of the karaya gum and colouring, to mimic the colour of the active powder.

They then took photographs of each lesion, measured the size of the ulcer with a special rule and showed the patients how to measure their own ulcers. The patients then recorded the size of their ulcers and and their pain using a visual analogue scale. They did this daily for 10 days every morning and night.

The participants, operators and evaluators were all blinded to the intervention.

The relevant statistical analysis was carried out using multilevel modelling which took into account several cofounders.

What did they find?

They showed that there were significant differences in the size of ulcers between the two groups. For example, at day five the ulcers in the experimental group were decreasing at 0.76 mm/day compared to 0.6 mm/day in the control group. While this difference was not great they also showed that the ulcers in the experimental group healed earlier than those in the control group by two days. There was no difference in overall pain between the two groups.

They pointed out that the effects of the active powder may have reduced secondary infections, which can prevent or delay healing. They also pointed out that there may also be a healing effect of the placebo because the gel covered the ulcer. This is a good illustration of a trial that used a placebo. They finally concluded that that the active powder was clinically effective and significantly reduced healing time.

When they considered that there was no effect of the active gel on pain, they pointed out that this may have been a true effect or could have resulted because of the small sample size and lack of power This could be rectified by carrying out a study that is powered on pain.

What did I think?

I think this was a very interesting study which was carried out to a high standard. One potential criticism may be that the patients measured their own ulcers, but this was the same for both groups and this should result in any bias in the study.

In previous posts I have pointed out that when we evaluate a study we need to look at the effect size and the confidence intervals of any differences. In interpreting this study my “take home’ message was that the use of the active gel reduced the presence of ulcers by two days but has no effect on pain. It is also important to consider that no harms were reported in the study. Nevertheless, there are concerns over the development of antibiotic resistance and I am not sure if the use of an oral gel contributes to this problem. We, therefore, need to decide whether this difference is sufficiently great to routinely prescribe the active gel.

I think that I will consider using this gel for patients with severe ulceration and point out to them that this will reduce their ulcers by two days.

ResearchBlogging.org
Rennick, L., Campbell, P., Naidu, A., Taylor, R., & Buschang, P. (2015). Effectiveness of a novel topical powder on the treatment of traumatic oral ulcers in orthodontic patients:

The Angle Orthodontist DOI: 10.2319/050415-303.1

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  1. Andy Sonis says:

    In thirty plus years of practice I recall only a single orthodontic appliance induced traumatic ulcer becoming secondardily infected. Remove the source of irritation/trauma and apply a palliative occlusive dressing. Not sure medications are necessary when a band aid will do the job. Current treatment philosophies are to try to minimize exposure to antibiotics.

    • Kevin O'Brien says:

      Hi Andy, I agree. I cannot help thinking the best way to reduce ulcers is not to cause them in the first place, by being careful with the ends of the wire…

  2. David Manger says:

    Dear Kevin

    This is very interesting as ulceration does cause considerable discomfort for patients.

    I note in title of the paper it refers to a powder but in your assessment you mention gels. Could you clarify whether gels or powder was used?

    Many thanks

    David

    • Kevin O'Brien says:

      Thanks. In the early part of the paper they mention the powder, but they then incorporated it into the gel for use in the mouth.

  3. Michaela says:

    Thank you for a nice paper.
    I use an oral gel with a low content of Lidocainum and patient are really satisfied and happy because the healing of an ulcus is about 3-4 days usually without pain.

    • Kevin O'Brien says:

      Thanks for the comment, yes this should work after removing the stimulus that caused the problem in the first place

  4. godfrey maronga says:

    Dear Kevin.
    thank you for the educative commentary.
    i have twice noted ulcers on the mucosa labial to labially placed canines during the alignment phase of treatment.these were caused by the hooks on the canine bracket. how best would you suggest i manage this? thank you.

  5. Ian Milne says:

    useful paper.I have always used mycostatin ointment for relief of angular ulcers that we see at the corners of the mouth.This clears the infection in a few days.
    does the material used in this study come ready made or do you have to engage a pharmacist to make it up separate for each patient.Great blog.

  6. Igor Gribalsky says:

    Thank you for the review of the trial. I find it very helpful to read your summarized notes regarding the articles. Much appreciated!
    My opinion pretty much aligns with what was already said. I generally believe that prevention and/or removal of the causing agent (wire in distal ends, ligature ties ends on brackets etc.) together with (probably the most important factor which was not emphasized enough) good oral hygiene control including proper diet should be enough to deal with traumatic ulcers. The only agent that might be valuable in my opinion is an anesthetic gel which immediately can decrease the discomfort. Must considered that it is temporary and probably clears out pretty fast but it might be the first step in “forgeting” about the ulcers and thus helping reducing the ulcer’s recurrent discomfort for a longer period

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