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

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.

Study Overview

• Status: Completed
• Conditions: Antioxidative Stress; Aphthous Stomatitis, Recurrent
• Intervention / Treatment: Combination product: placebo gel; Combination product: camel whey protein gel

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Kafr Ash Shaykh, Egypt, 21614
    • Walid Elamrousy
  • Kafrelsheikh
    • Kafr Ash Shaykh, Kafrelsheikh, Egypt, 214312
      • oral medicine and periodontology outpatient clinic, faculty of dentistry, kafrelsheikh University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo gel; Methylcellulose gel was applied to the ulcer till complete healing	Combination product: placebo gel; just methyl cellulose gel was applied to the ulcer
Experimental: camel whey protein gel; camel whey protein dissolved in methycellulose gel was applied to the ulcer till complete healing	Combination product: camel whey protein gel; camel whey protein gel was prepared and dissolved in methyl cellulose gel base and applied to the ulcer

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Kafrelsheikh University

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2021
• Primary Completion (Actual): October 15, 2021
• Study Completion (Actual): November 30, 2021

Study Registration Dates

• First Submitted: May 8, 2021
• First Submitted That Met QC Criteria: May 8, 2021
• First Posted (Actual): May 13, 2021

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 9, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Stomatitis; Stomatitis, Aphthous
• Other Study ID Numbers: KFSAPH2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No