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

NCT07004465 | Completed DMC

• 1 other identifier: Dent/UO-Kerbala/3-14122024
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 2

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

Conditions

Mouth Ulcer

Outcome Measures

Primary Outcomes (1)

• pain reduction

  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

  8 days

Secondary Outcomes (1)

• ulcer size

  8 days

Study Arms (2)

vitamin B12

EXPERIMENTAL

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

Dietary Supplement: cyanocobalamin

Kenalog in Orabase

EXPERIMENTAL

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

Device: triamcinolone acetonide

Interventions

cyanocobalamin DIETARY_SUPPLEMENT

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

vitamin B12

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

Kenalog in Orabase

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Orthodontic adult patients older than 18 years.
• Ulcer due to trauma not more than 10 mm in size.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hawraa Ali Abdullah: lead

Study Sites (2)

Karbala university

Karbala, Karbala Governorate, 56001, Iraq

Location

Kerbala University

Karbala, Kerbala, 56001, Iraq

Location

Related Links

• college of dentistry / kerbala university

MeSH Terms

Conditions

Oral Ulcer

Interventions

Vitamin B 12

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assist lecturer

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 4, 2025
• Study Start: August 19, 2025
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IR (2)