Camel Whey Protein Gel for the Treatment of Aphthous Ulcer
Primary Purpose
Aphthous Stomatitis, Recurrent, Antioxidative Stress
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
placebo gel
camel whey protein gel
Sponsored by
About this trial
This is an interventional treatment trial for Aphthous Stomatitis, Recurrent
Eligibility Criteria
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
Sites / Locations
- oral medicine and periodontology outpatient clinic, faculty of dentistry, kafrelsheikh University
- Walid Elamrousy
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
placebo gel
camel whey protein gel
Arm Description
Methylcellulose gel was applied to the ulcer till complete healing
camel whey protein dissolved in methycellulose gel was applied to the ulcer till complete healing
Outcomes
Primary Outcome Measures
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
ulcer duration
time extended from ulcer presence till disseverance
Secondary Outcome Measures
immunological analysis
the values of serum TNF-α, Il1, IL6 were measured before and after gel application using flow cytometry
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04886011
Brief Title
Camel Whey Protein Gel for the Treatment of Aphthous Ulcer
Official Title
Evaluation of Novel Topical Camel Whey Protein Gel for the Treatment of Recurrent Aphthous Stomatitis: Randomised Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 15, 2021 (Actual)
Primary Completion Date
October 15, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kafrelsheikh University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphthous Stomatitis, Recurrent, Antioxidative Stress
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Methylcellulose gel
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo gel
Arm Type
Placebo Comparator
Arm Description
Methylcellulose gel was applied to the ulcer till complete healing
Arm Title
camel whey protein gel
Arm Type
Experimental
Arm Description
camel whey protein dissolved in methycellulose gel was applied to the ulcer till complete healing
Intervention Type
Combination Product
Intervention Name(s)
placebo gel
Intervention Description
just methyl cellulose gel was applied to the ulcer
Intervention Type
Combination Product
Intervention Name(s)
camel whey protein gel
Intervention Description
camel whey protein gel was prepared and dissolved in methyl cellulose gel base and applied to the ulcer
Primary Outcome Measure Information:
Title
pain level
Description
visual analog scale to measure pain level from 0 to 10. 0 means no pain at all and 10 means the most sever pain
Time Frame
1 week
Title
ulcer duration
Description
time extended from ulcer presence till disseverance
Time Frame
10 days
Secondary Outcome Measure Information:
Title
immunological analysis
Description
the values of serum TNF-α, Il1, IL6 were measured before and after gel application using flow cytometry
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
oral medicine and periodontology outpatient clinic, faculty of dentistry, kafrelsheikh University
City
Kafr Ash Shaykh
State/Province
Kafrelsheikh
ZIP/Postal Code
214312
Country
Egypt
Facility Name
Walid Elamrousy
City
Kafr Ash Shaykh
ZIP/Postal Code
21614
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Camel Whey Protein Gel for the Treatment of Aphthous Ulcer
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