Oral Lichen Planus
Conditions
Brief summary
Bromelain, an enzyme extract derived from pineapples, has shown promise due to its anti-inflammatory and wound-healing properties. However, its efficacy in treating oral mucosal ulcers remains unexplored. This study aims to provide clinical evidence on the efficacy of bromelain for managing OLP, potentially offering a safer and more effective treatment option.
Interventions
DIETARY_SUPPLEMENTTopical Bromelain
A natural enzyme-based formulation derived from pineapple, bromelain in orabase is being investigated for its anti-inflammatory and wound-healing properties. As a non-steroidal alternative, it offers a potentially safer treatment option with minimal side effects.
DRUG0.1% topical triamcinolone acetonide
A corticosteroid-based standard treatment for OLP, triamcinolone acetonide in orabase is used for its strong anti-inflammatory and immunosuppressive effects. It serves as the conventional treatment versus novel therapy in this study
COMBINATION_PRODUCTCombination of Topical Bromelain and Triamcinolone Acetonide in Orabase
This novel formulation combines the enzymatic, healing properties of bromelain with the anti-inflammatory property of triamcinolone. It is designed to provide enhanced therapeutic effects through synergistic action, potentially reducing the required corticosteroid dose while improving clinical outcomes.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients suffering from symptomatic OLP * Patients free from any visible oral lesions other than OLP. * Patients who agreed to take the supplied interventions. * Patient who will agree to participate in the study. * Patients who will accept to sign the informed consent.
Exclusion criteria
* Patients suffering from any systemic disease. * Treatment with any systemic treatment such as systemic steroids, other immunosuppressive drugs or non-steroidal anti-inflammatory drugs at least eight weeks. * Treatment with any oral topical medications for at least four weeks prior to the study. * Pregnant and lactating mothers.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical improvement | Recorded at baseline, and weekly for 4 weeks | Clinical improvement will be measured using Thongprasom et al. scoring system. In Thongprasom et al. scale, lesions are given score as follows: 0, no lesions, normal mucosa; 1, Mild white striae, no erythematous area; 2, White striae with atrophic area \< 1 cm2; 3, White striae with atrophic area \> 1 cm2; 4, White striae with erosive area \< 1 cm2 and 5, White striae with erosive area \> 1 cm2 (Thongprasom et al., 2003). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | baseline, daily for the first week, then weekly for the remaining 3 weeks. | Pain intensity will be measured using Visual analogue scale (VAS), VAS is a self-reported pain score ranging from 0 to 10 (Cheng et al., 2012) at baseline, daily for the first week, then weekly for the remaining 3 weeks. |
| Oral health-related quality of life | at baseline, and weekly for the 4 weeks. | Oral health-related quality of life using Oral Health Impact Profile-14 (OHIP-14) Oral health-related quality of life is a five-point Likert-type scale used in scoring each item of the OHIP-14. Responses are coded 0 = never', 1 = hardly ever', 2 = occasionally', 3 = fairly often', 4 = very often'. Item responses are summed to produce an OHIP-14 total score. Total OHIP-14 scores range from 0 (no impact) to 56 (all of the oral health problems are experienced very often). High scores indicates a poor oral health-related quality of life (Wiriyakijja et al., 2018). |
Countries
Egypt
Outcome results
None listed