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Camel Whey Protein Gel for the Treatment of Aphthous Ulcer

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04886011
Enrollment
20
Registered
2021-05-13
Start date
2021-05-15
Completion date
2021-11-30
Last updated
2023-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antioxidative Stress, Aphthous Stomatitis, Recurrent

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

Interventions

COMBINATION_PRODUCTplacebo gel

just methyl cellulose gel was applied to the ulcer

COMBINATION_PRODUCTcamel whey protein gel

camel whey protein gel was prepared and dissolved in methyl cellulose gel base and applied to the ulcer

Sponsors

Kafrelsheikh University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention model description

Methylcellulose gel

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
pain level1 weekvisual analog scale to measure pain level from 0 to 10. 0 means no pain at all and 10 means the most sever pain
ulcer duration10 daystime extended from ulcer presence till disseverance

Secondary

MeasureTime frameDescription
immunological analysis10 daysthe values of serum TNF-α, Il1, IL6 were measured before and after gel application using flow cytometry

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026