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| Name | Class |
|---|---|
| Cairo University | OTHER |
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Oral lichen planus patients who will meet inclusion criteria will be divided into 2 groups
-The intervention group (Group P): This group will be randomly allocated to take one capsule twice daily during meal time at morning and evening of probiotics complex obtained from Biovea for 4 -week study period. Moreover, patients in this group will be instructed to apply clobetasole propionate in orabase gel 2 times daily for 4 weeks. Patients will receive their supply of the gel and probiotics every 2 weeks. The control group (Group B): This group will be randomly allocated to apply clobetasol propionate in orabase gel 4 times daily after meal times and before sleeping for 4 weeks. At the 3rd week this group will be instructed to apply miconazole gel 4 times daily as a prophylaxis for two weeks.
Salivary sample collection: Unstimulated salivary sample was collected from all participants twice , once at baseline and another time after 4 weeks from the study period. Saliva was collected in graduated clear test tubes to be used in the evaluation of candidal counts before and after treatment .
Patient's visits was at baseline, 2 weeks and 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| systemic probiotic (A) | Active Comparator | Systemic probiotic capsules will be given twice daily in addition to topical application of topical clobetasol in orabase twice daily |
|
| topical corticosteroid (B) | Active Comparator | topical clobetasol in orabse application will be given 4 times daily ( 3 times after meals and once before bed time) prophylactic topical antifungal will be given in the fourth week to prevent candidal infection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic Blend Oral capsules | Drug | probtiotic bend oral tablets from biovia will be adminestrated containing 4 strains ( twice daily) in addition to topical clobetasol application twice daily |
| Measure | Description | Time Frame |
|---|---|---|
| size wound | thongprasom scale | 0 , 2 weeks and 4 weeks |
| Pain in oral cavity | Numerical rating scale (0-10) 0= minimal pain 10 unbearable pain | 0 , 2 weeks and 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| candidal load assessment | culturing technique in CFU unit | 0 and 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amira Abdelwhab, lecturer | Contact | 01007647877 | amira.abdelwhab.dent@o6u.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| yasmine kamal, lecturer | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Recruiting | Cairo | +2 | Egypt |
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| ID | Term |
|---|---|
| D017676 | Lichen Planus, Oral |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D008010 | Lichen Planus |
| D017512 | Lichenoid Eruptions |
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| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| C056627 | Orabase |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| Corticosteroids for Local Oral Treatment | Drug | topical clobetasol probionate in orabase application 4 times daily |
|
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| D017444 |
| Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |