Mouth UlcerB12-KEN-TRAUMNCT07004465
Effectiveness of Vitamin b12 Versus Kenalog on Traumatic Ulcer Associated With Orthodontic Treatment
A study testing cyanocobalamin and triamcinolone acetonide in people with Mouth Ulcer, run by Hawraa Ali Abdullah at 2 sites in Iraq.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Mouth Ulcer
- What is being tested?
- cyanocobalamin and triamcinolone acetonide
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 2 sitesIraq
- Study dates
- 19 Aug 2025to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Orthodontic adult patients older than 18 years.
- Ulcer due to trauma not more than 10 mm in size.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Iraq2 sites
Karbala university
Karbala, Karbala Governorate, 56001
Kerbala University
Karbala, Kerbala, 56001
About this study
Official title: Effectiveness of Vitamin b12 Versus Kenalog in Orabase on Traumatic Ulcer Associated With Orthodontic Treatment: Randomized Control Trial
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
Read the 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.
- Conditions
- Mouth Ulcer
- Being tested
- cyanocobalamin, triamcinolone acetonide
- Medical subject headings
- Oral Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyanocobalaminDietary supplement
Group A will be given vitamin B12 tablets (1000 mcg) once daily.
triamcinolone acetonideDevice
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
| Study group | Role | What they receive |
|---|---|---|
| vitamin B12 | Experimental | Vitamin B12, also known as cobalamin, is a water-soluble vitamin involved in metabolism Receives: 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 Receives: Device: triamcinolone acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 days
Secondary outcomes (1)
ulcer size
measuring ulcer size using vernier will be done on fourth and eighth days for both groups
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start19 Aug 2025
- Primary completion28 Feb 2026
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mouth UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hawraa Ali Abdullah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hawraa Ali Abdullah, Karbala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07004465
- Sponsor's protocol ID
- Dent/UO-Kerbala/3-14122024
- Other IDs
- Dent/UO-Kerbala/3-14122024
- Acronym
- B12-KEN-TRAUM
- Status last verified
- Feb 2026
- First submitted
- 26 May 2025
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: for ethical consideration
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Vitamin b12 Versus Kenalog in Orabase on Traumatic Ulcer Associated With Orthodontic Treatment: Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07004465
- Acronym / sponsor ID
- B12-KEN-TRAUM / Dent/UO-Kerbala/3-14122024
- Conditions
- Mouth Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Hawraa Ali AbdullahUniversity, hospital or other
- Study start
- 19 Aug 2025 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 4 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin B12 | Experimental | Dietary Supplement: cyanocobalaminVitamin B12, also known as cobalamin, is a water-soluble vitamin involved in metabolism |
| Kenalog in Orabase | Experimental | Device: triamcinolone acetonideThe active substance is triamcinolone acetonide 40 mg/ml. The other ingredients are; benzyl alcohol, polysorbate 80, carmellose sodium, sodium chloride and water |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Orthodontic adult patients older than 18 years.
- Ulcer due to trauma not more than 10 mm in size.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cyanocobalaminGroup A will be given vitamin B12 tablets (1000 mcg) once daily. | Dietary supplement | vitamin B12 |
| triamcinolone acetonideGroup 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 | Device | Kenalog in Orabase |
Primary outcome
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
1 secondary outcome
ulcer size
Time frame: 8 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- college of dentistry / kerbala universityLink provided by the sponsor.
- Individual participant dataSharing planned: No. for ethical consideration
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cyanocobalamin and triamcinolone acetonide in people with Mouth Ulcer, run by Hawraa Ali Abdullah at 2 sites in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain reduction (time frame: 8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.