cyanocobalamin
Dietary SupplementGroup A will be given vitamin B12 tablets (1000 mcg) once daily.
NCT Number: NCT07004465
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
Looking for future studies?
Notify Me18 year–40 year
All sexes
Interventional
Not applicable
Karbala university, Karbala, Karbala Governorate, Iraq
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Group A will be given vitamin B12 tablets (1000 mcg) once daily.
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
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
Time frame: 8 days
measuring ulcer size using vernier will be done on fourth and eighth days for both groups
Hawraa Ali Abdullah
Other
Effectiveness of Vitamin b12 Versus Kenalog in Orabase on Traumatic Ulcer Associated With Orthodontic Treatment: Randomized Control Trial
Acronym: B12-KEN-TRAUM
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.
Published trials that share one or more normalized conditions with this study.
NCT06969495
Mouth Diseases, Mouth Ulcer
Jenjarum, Selangor, Malaysia
View Trial DetailsNCT05247333
Acne, Acne Vulgaris
Madrid, Spain
View Trial DetailsNCT07723612
Mouth Diseases, Mouth Ulcer
Yiwu, Zhejiang, China
View Trial DetailsNCT07709455
Mouth Diseases, Oral Mucosal Ulceration
Karachi, Pakistan
View Trial Details