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| ID | Type | Description | Link |
|---|---|---|---|
| Dent/UO-Kerbala/3-14122024 | Other Identifier | kerbala university |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vitamin B12 | Experimental | Vitamin B12, also known as cobalamin, is a water-soluble vitamin involved in metabolism |
|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cyanocobalamin | Dietary Supplement | Group A will be given vitamin B12 tablets (1000 mcg) once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| ulcer size | measuring ulcer size using vernier will be done on fourth and eighth days for both groups | 8 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karbala university | Karbala | Karbala Governorate | 56001 | Iraq | ||
| Kerbala University |
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| Label | URL |
|---|---|
| college of dentistry / kerbala university | View source |
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for ethical consideration
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| ID | Term |
|---|---|
| D019226 | Oral Ulcer |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D014805 | Vitamin B 12 |
| ID | Term |
|---|---|
| D045728 | Corrinoids |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 |
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| 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 |
|
| Karbala |
| Kerbala |
| 56001 |
| Iraq |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |