Effectiveness of Vitamin b12 Versus Kenalog on Traumatic Ulcer Associated With Orthodontic Treatment (B12-KEN-TRAUM)

Hawraa Ali Abdullah

Status: Begins enrollment in 1 month

Conditions: Mouth Ulcer

Treatments: Dietary Supplement: cyanocobalamin; Device: triamcinolone acetonide

Study type: Interventional

Funder types: Other

Identifiers

NCT07004465

Dent/UO-Kerbala/3-14122024 (Other Identifier)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 76 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

vitamin B12

Experimental group

Description:

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

Treatment:

Dietary Supplement: cyanocobalamin

Kenalog in Orabase

Experimental group

Description:

The active substance is triamcinolone acetonide 40 mg/ml. The other ingredients are; benzyl alcohol, polysorbate 80, carmellose sodium, sodium chloride and water

Treatment:

Device: triamcinolone acetonide