Camel Whey Protein Gel for the Treatment of Aphthous Ulcer

Kafrelsheikh University

Status: Completed

Conditions: Antioxidative Stress; Aphthous Stomatitis, Recurrent

Treatments: Combination Product: placebo gel; Combination Product: camel whey protein gel

Study type: Interventional

Funder types: Other

Identifiers

NCT04886011

KFSAPH2021

Details and patient eligibility

About

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.

Full 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

Enrollment: 20 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

placebo gel

Placebo Comparator group

Description:

Methylcellulose gel was applied to the ulcer till complete healing

Treatment:

Combination Product: placebo gel

camel whey protein gel

Experimental group

Description:

camel whey protein dissolved in methycellulose gel was applied to the ulcer till complete healing

Treatment:

Combination Product: camel whey protein gel