Effectiveness of Vitamin b12 Versus Kenalog on Traumatic Ulcer Associated With Orthodontic Treatment

What Was Tested

In this not phased trial, researchers set out to test Cyanocobalamin (Vitamin B12).

It had two arms (groups): vitamin B12 (experimental) and Kenalog in Orabase (experimental).

Vitamin B12, also known as cobalamin, is a water-soluble vitamin involved in metabolism.

The registry classes the interventions as device and dietary supplement.

More on the Plan

Recurrent aphthous stomatitis (RAS), commonly called "canker sores," is a perplexing oral condition characterized by the recurrent development of painful aphthous ulcers on non-keratinized oral mucous membranes.

Certain factors predispose to RAS, including local trauma, stress, smoking cessation, anemia, and hematinic deficiency.

Data also supports the prevalence of traumatic ulcers in the oral cavity and periodontal diseases.

Ulcerations can happen due to brackets, bands, arch wires and long unsupported stretches of wire resting against the lips.

Who Took Part

82 actual participants took part.

It was open to people of any sex aged from 18 years up to 40 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Orthodontic adult patients older than 18 years. Ulcer due to trauma not more than 10 mm in size.

The full record lists 2 inclusion and 6 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Cyanocobalamin (Vitamin B12) group and the comparison group should start out alike.

The Cyanocobalamin (Vitamin B12) group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Cyanocobalamin (Vitamin B12) study: the participants and staff both knew the treatment.

It started in 2025-08-19 with completion listed for 2026-02-28.

It ran at 2 sites in Iraq (2).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 1 secondary outcome, for example ulcer size.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cyanocobalamin (Vitamin B12) in 82 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.