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Completed

NCT Number: NCT04886011

Camel Whey Protein Gel for the Treatment of Aphthous Ulcer

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.

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Key information

Conditions

Aphthous Stomatitis, Recurrent Antioxidative Stress Sutton disease 2

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

oral medicine and periodontology outpatient clinic, faculty of dentistry, kafrelsheikh University, Kafr ash Shaykh, Kafrelsheikh, Egypt

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

placebo gel

Combination Product

just methyl cellulose gel was applied to the ulcer

camel whey protein gel

Combination Product

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

Primary outcomes

  1. pain level

    Time frame: 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

  2. ulcer duration

    Time frame: 10 days

    time extended from ulcer presence till disseverance

Secondary outcomes

  1. immunological analysis

    Time frame: 10 days

    the values of serum TNF-α, Il1, IL6 were measured before and after gel application using flow cytometry

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 13, 2021
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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