Clinical trial NCT04886011: Camel Whey Protein Gel for the Treatment of Aphthous Ulcer
Official title: Evaluation of Novel Topical Camel Whey Protein Gel for the Treatment of Recurrent Aphthous Stomatitis: Randomised Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphthous Stomatitis, Recurrent
Antioxidative Stress
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2021-05-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Methylcellulose gel
Primary purpose: TREATMENT

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: pain level
timeFrame: 1 week
measure: ulcer duration
timeFrame: 10 days
Secondary outcomes:
measure: immunological analysis
timeFrame: 10 days
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: oral medicine and periodontology outpatient clinic, faculty of dentistry, kafrelsheikh University
state: Kafrelsheikh
city: Kafr Ash Shaykh
country: Egypt
facility: Walid Elamrousy
Study officials:
References: