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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo tube | Placebo Comparator | neutral material without any biological effects |
|
| Combination of diclofenac potassium and propolis | Active Comparator | active agents combination of diclofenac potassium 3% (10 mg/g, 60 g, EMS) and Propolis 5% gel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combination of diclofenac potassium and propolis | Combination Product | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| chronic oral mucosal disease questionnaire | patient response | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| ulcer characters | size | 10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Al Azhar university | Cairo | 11825 | Egypt |
individual participant data can be shared through the organization
6 months
main investigator
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| ID | Term |
|---|---|
| D013280 | Stomatitis |
| D019226 | Oral Ulcer |
| D009059 | Mouth Diseases |
| ID | Term |
|---|---|
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D011429 | Propolis |
| ID | Term |
|---|---|
| D012116 | Resins, Plant |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
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A randomized clinical, double-blind, placebo-controlled study
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caregiver and participants and investigator are masked
|
| placebo | Other | placebo |
|
| D053147 |
| Plant Exudates |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |