Recurrent Aphthous Stomatitis
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENT35% Topical Bromelain in Orabase
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.
DIETARY_SUPPLEMENT50% Topical Bromelain in Orabase
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.
DRUG0.1% Topical Triamcinolone Acetonide in Orabase
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
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 18-60 years. * Diagnosed with RAS. * Onset of ulcer within the last 48 hours. * Willingness to participate and provide informed consent.
Exclusion criteria
* History of hematological deficiencies, GIT disorders, Behcet's disease and major systemic diseases. * Pregnant or breastfeeding patients. * Previous treatment for the current ulcer episode.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain associated with ulcers | Recorded at baseline, day 2, day 4 and day 7 | Pain reduction will be measured using a visual analog scale (VAS). VAS is a self-reported pain scores ranging from 0 to 10 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in ulcer size | Recorded at baseline, day 2, day 4 and day 7 | The reduction in ulcer size will be assessed using periodontal probe to measure dimensions in millimeters (mm) |
| Number of oral ulcers | Recorded at baseline, day 2, day 4 and day 7 | — |
| Healing time of oral ulcer | Recorded at baseline, day 2, day 4 and day 7 | The time to complete healing will be determined by the number of days until the ulcer is no longer visible upon clinical examination |
| Oral ulcer activity index | Recorded at baseline, day 2, day 4 and day 7 | 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) |
Outcome results
None listed