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

Not Applicable

Not yet recruiting

• Conditions: Mouth Ulcer

• Registration Number: NCT07004465
• Lead Sponsor: Hawraa Ali Abdullah

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2025-05-26
• Study First Submitted QC: 2025-05-26
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-03
• Study First Posted: 2025-06-04
• Last Update Posted: 2025-06-06
• Study Start: 2025-08-19
• Primary Completion: 2025-12-19
• Study Completion: 2026-01-19

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 76

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
pain reduction	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 Outcome Measures

Name	Time	Method
ulcer size	8 days	measuring ulcer size using vernier will be done on fourth and eighth days for both groups

Trial Locations

Locations (1)

Karbala university; 🇮🇶 Karbala, Iraq