Camel Whey Protein Gel for the Treatment of Aphthous Ulcer

Study Overview
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Brief Summary
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Higher prevalence of recurrent aphthous ulcer in young adults and the severity decreased with increasing age. The etiology of aphthous ulcer remains unclear. Other possible factors include trauma, drug use, deficiency in vitamin B12, folic acid, iron, stress, hormonal changes and metabolic diseases. Many topical agents such as local and systemic an- tibiotics, local antiseptics, topical NSAIDs, and topical corticosteroids are generally prescribed for symptomatic relief. Several approved drug for- mulations such as pills, mouthwash, sprays and paste such as vitamin B12, chlorhexidine mouthwash, steroid lozenges and local anesthetics are primarily suggested for the treatment of aphthous ulcer. Camel whey protein gel was fabricated to get benefits of its antiinflammatory, immunomodulator, Antibacterial and antioxidant effects.

Detailed Description
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40 cases of recurrent aphthous ulcer patients as the research object,were randomly divide into the study group and the control group, each with 20 cases of both sexes with age ranging from 18 years to 50 years. Inclusion criteria consisted of the following: (a) clinical examination and confirmed history of recurrent oral ulcer, (b) recurrence of the oral ulceration, and (c) patients in good condition with no serious systemic disease. Eligible persons were excluded if they were administered antibiotics or glucocorticoids or accepted periodontal or dental treat- ments that interfered with the results of our experimental drugs. the control group will be subjected to placebo gel consisting of methyl cellulose gel whereas the study group will use camel whey protein dissolved in methyl cellulose gel base. the gel will be applied 1 day after ulcer appearance and will be stopped after ulcer disappearance

Official Title
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Evaluation of Novel Topical Camel Whey Protein Gel for the Treatment of Recurrent Aphthous Stomatitis: Randomised Clinical Study

Conditions
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Aphthous Stomatitis, Recurrent, Antioxidative Stress

Intervention / Treatment
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* Combination Product: placebo gel
* Combination Product: camel whey protein gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical examination and confirmed history of recurrent oral ulcer, recurrence of the oral ulceration patients in good condition with no serious systemic disease. Exclusion Criteria: if they were administered antibiotics or glucocorticoids accepted periodontal or dental treat-ments that interfered with the results of our experimental drugs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Methylcellulose gel
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo gel<br>Methylcellulose gel was applied to the ulcer till complete healing | Combination Product: placebo gel<br>* just methyl cellulose gel was applied to the ulcer<br>|
| Experimental: camel whey protein gel<br>camel whey protein dissolved in methycellulose gel was applied to the ulcer till complete healing | Combination Product: camel whey protein gel<br>* camel whey protein gel was prepared and dissolved in methyl cellulose gel base and applied to the ulcer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain level | visual analog scale to measure pain level from 0 to 10. 0 means no pain at all and 10 means the most sever pain | 1 week | 
| ulcer duration | time extended from ulcer presence till disseverance | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| immunological analysis | the values of serum TNF-α, Il1, IL6 were measured before and after gel application using flow cytometry | 10 days |