Oral Infection, Oral Mucositis, Oral Ulcer, ORAS
Conditions
Keywords
diclofenac, oral disease, oral Aphthosis, propolis
Brief summary
The combination of diclofenac and propolis could enhance the healing of recurrent aphthous ulcers, instantly relieve symptoms, improve the quality of life, and present a de novo and cost-effective regime help in oral ulcer treatment. This study aimed to evaluate the influence of diclofenac and propolis combination as a gel in the treatment of recurrent oral ulceration
Interventions
COMBINATION_PRODUCTCombination of diclofenac potassium and propolis
Patients will be divided into two groups: the first one will be treated with a combination of diclofenac 3% (10 mg/g, 60 g, EMS) and Propolis 5% gel and the second one is placebo group. Participants will be allocated randomly. The patients will be asked to apply gel 2 times per day. The patients will be instructed, not to eat or drink for 1 h after application of the gel
OTHERplacebo
placebo
Sponsors
Al-Azhar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
caregiver and participants and investigator are masked
Intervention model description
A randomized clinical, double-blind, placebo-controlled study
Eligibility
Sex/Gender
ALL
Age
5 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* patients have an oral mucosal ulcer
Exclusion criteria
* patients allergic to any component of the diclofenac formulation and other NSAIDs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| chronic oral mucosal disease questionnaire | 10 days | patient response |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ulcer characters | 10 days | size |
Countries
Egypt
Outcome results
None listed