Camel Whey Protein Gel for the Treatment of Aphthous Ulcer

Not Applicable

Completed

• Conditions: Aphthous Stomatitis, Recurrent; Antioxidative Stress
• Interventions: Combination Product: camel whey protein gel; Combination Product: placebo gel

• Registration Number: NCT04886011
• Lead Sponsor: Kafrelsheikh University

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

Study Timeline

• Study First Submitted: 2021-05-08
• Study First Submitted QC: 2021-05-08
• Study First Posted: 2021-05-13
• Study Start: 2021-05-15
• Primary Completion: 2021-10-15
• Study Completion: 2021-11-30
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-09
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

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Exclusion Criteria

• if they were administered antibiotics or glucocorticoids
• accepted periodontal or dental treat-ments that interfered with the results of our experimental drugs

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
camel whey protein gel	camel whey protein gel	camel whey protein dissolved in methycellulose gel was applied to the ulcer till complete healing
placebo gel	placebo gel	Methylcellulose gel was applied to the ulcer till complete healing

Primary Outcome Measures

Name	Time	Method
ulcer duration	10 days	time extended from ulcer presence till disseverance
pain level	1 week	visual analog scale to measure pain level from 0 to 10. 0 means no pain at all and 10 means the most sever pain

Secondary Outcome Measures

Name	Time	Method
immunological analysis	10 days	the values of serum TNF-α, Il1, IL6 were measured before and after gel application using flow cytometry

Trial Locations

Locations (2)

oral medicine and periodontology outpatient clinic, faculty of dentistry, kafrelsheikh University; 🇪🇬 Kafr Ash Shaykh, Kafrelsheikh, Egypt

Walid Elamrousy; 🇪🇬 Kafr Ash Shaykh, Egypt