Can a vitamin soothe braces sores? new study pits B12 against standard gel
NCT ID NCT07004465
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether vitamin B12 tablets can ease painful mouth ulcers caused by braces, comparing them to a standard steroid gel (Kenalog). 82 adults with traumatic ulcers were split into two groups. Researchers measured pain and ulcer size after 4 and 8 days to see which treatment worked better.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- vitamin B12 (cyanocobalamin) and triamcinolone acetonide (Kenalog)
- What this could lead to
- If vitamin B12 works as well as Kenalog, it could offer a simpler, over-the-counter option for managing mouth sores from braces.
- What could go wrong
- This is a small, completed trial with only 82 participants. Results may not apply to everyone, and vitamin B12 might not reduce pain as effectively as the standard treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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82 people
The number who actually took part.
- Started
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Aug 2025
- Finished
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Feb 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 40 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Orthodontic adult patients older than 18 years. * Ulcer due to trauma not more than 10 mm in size. Exclusion Criteria: * Patients who had known systemic diseases. * Concurrent with lesions in the mouth (Bechet's disease, rheumatoid. arthritis, lupus, and acquired immune deficiency syndrome). * A patient who had received other concurrent treatment for aphthous ulcers. * Patients with chronic diseases such as liver diseases, rheumatoid arthritis, diabetes, cancer, and renal diseases. * Pregnant or nursing women. * Patient who had a known vitamin B12 deficiency.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Karbala university
Karbala, Karbala Governorate, 56001, Iraq
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Kerbala University
Karbala, Kerbala, 56001, Iraq
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