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Completed

NCT Number: NCT07004465

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

The study is a randomized controlled trial. the participants will be equally divided into two groups to compare the clinical effectiveness of vitamin b12 versus kenalog in treatment of traumatic ulcers associated with orthodontic treatment during

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karbala university, Karbala, Karbala Governorate, Iraq

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About this study

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. Recurrent aphthous stomatitis is a relatively common condition, affecting up to 25% of the worldwide population. Certain factors predispose to RAS, including local trauma, stress, smoking cessation, anemia, and hematinic deficiency. In the patient who undergoes orthodontic management, there is improvement in the dental and facial aesthetics and development of self-confidence. 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.

Vitamin B12, also known as Cobalamin, is a water-soluble vitamin primarily found in animal products; plays a vital role in the formation of hematopoietic stem cells and vitaminB12 deficiency may play a role in the pathogenesis of recurring aphthous (RAS). TRIAMCINOLONE (Kenalog in Orabase) treats and relieves discomfort caused by mouth sores. It works by decreasing inflammation in the mouth. It belongs to a group of medications called topical steroids.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cyanocobalamin

Dietary Supplement

Group A will be given vitamin B12 tablets (1000 mcg) once daily.

triamcinolone acetonide

Device

Group B will be given Kenalog gel (triamcinolone acetonide 40 mg/ml). The other ingredients are benzyl alcohol, polysorbate 80, carmellose sodium, sodium chloride and water, by covering the area twice daily

Primary outcomes

  1. pain reduction

    Time frame: 8 days

    The primary outcome will be the reduction in pain intensity at day 4 and day 8 after treatment using a visual analog scale and recording measurements, respectively, for both groups.

    visual analogue scale from 0 cm (no pain) to 10 cm (severe to worst pain), which represents the intensity of subjective experience

Secondary outcomes

  1. ulcer size

    Time frame: 8 days

    measuring ulcer size using vernier will be done on fourth and eighth days for both groups

Sponsors and collaborators

Lead sponsor

Hawraa Ali Abdullah

Other

Registry information

Official study title

Effectiveness of Vitamin b12 Versus Kenalog in Orabase on Traumatic Ulcer Associated With Orthodontic Treatment: Randomized Control Trial

Acronym: B12-KEN-TRAUM

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 4, 2025
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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