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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
63
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.
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.
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
Time frame: Recorded at baseline, day 2, day 4 and day 7
Reduction in ulcer size
The reduction in ulcer size will be assessed using periodontal probe to measure dimensions in millimeters (mm)
Time frame: Recorded at baseline, day 2, day 4 and day 7
Number of oral ulcers
Time frame: 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
Time frame: 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)
Time frame: Recorded at baseline, day 2, day 4 and day 7
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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