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Bromelain, a natural product, exhibits anti-inflammatory, immunomodulatory, and wound-healing properties. However, its efficacy in treating oral mucosal ulcers remains unexplored. This study aims to evaluate the effect of bromelain as a safe alternate for management of RAS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 35% Topical Bromelain in Orabase | Experimental | Participants in this group will receive 35% bromelain gel incorporated into an orabase adhesive medium. |
|
| 50% Topical Bromelain in Orabase | Experimental | Participants assigned to this group will be treated with 50% bromelain gel formulated in orabase. |
|
| 0.1% Topical Triamcinolone Acetonide in Orabase | Active Comparator | This group will receive the standard treatment of 0.1% triamcinolone acetonide in orabase, commonly used for managing Recurrent Aphthous Stomatitis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 35% Topical Bromelain in Orabase | Dietary Supplement | Bromelain is a natural proteolytic enzyme derived from pineapple, recognized for its broad range of pharmacological properties. It exhibits significant anti-inflammatory effects by reducing edema. In addition to its anti-inflammatory activity, bromelain possesses antioxidant and analgesic properties. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain associated with ulcers | Pain reduction will be measured using a visual analog scale (VAS). VAS is a self-reported pain scores ranging from 0 to 10 | Recorded at baseline, day 2, day 4 and day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in ulcer size | The reduction in ulcer size will be assessed using periodontal probe to measure dimensions in millimeters (mm) | Recorded at baseline, day 2, day 4 and day 7 |
| Number of oral ulcers |
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Inclusion Criteria:
Exclusion Criteria:
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|
| 50% Topical Bromelain in Orabase | Dietary Supplement | Bromelain is a natural proteolytic enzyme derived from pineapple, recognized for its broad range of pharmacological properties. It exhibits significant anti-inflammatory effects by reducing edema. In addition to its anti-inflammatory activity, bromelain possesses antioxidant and analgesic properties. |
|
| 0.1% Topical Triamcinolone Acetonide in Orabase | Drug | Triamcinolone acetonide in orabase, a corticosteroid-based standard treatment for Recurrent Aphthous Stomatitis (RAS), is used for its strong anti-inflammatory and immunosuppressive effects. In this study, it serves as the conventional treatment against the novel therapy |
|
| Recorded at baseline, day 2, day 4 and day 7 |
| Healing time of oral ulcer | The time to complete healing will be determined by the number of days until the ulcer is no longer visible upon clinical examination | Recorded at baseline, day 2, day 4 and day 7 |
| Oral ulcer activity index | Oral ulcer activity index will be measured by Composite index (CI). CI score (0-10) is calculated by summing of subscale scores of oral ulcer activity (0 vs 1), oral ulcer-related pain status evaluated by categorized VAS (0-5) and the mean global functional disability score evaluated by 5-point Likert-type scale (0-4) | Recorded at baseline, day 2, day 4 and day 7 |
| ID | Term |
|---|---|
| D013281 | Stomatitis, Aphthous |
| ID | Term |
|---|---|
| D013280 | Stomatitis |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D001963 | Bromelains |
| C056627 | Orabase |
| D014222 | Triamcinolone Acetonide |
| ID | Term |
|---|---|
| D003546 | Cysteine Endopeptidases |
| D057056 | Cysteine Proteases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D010450 | Endopeptidases |
| D014221 | Triamcinolone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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