Oral Ulcer
Conditions
Keywords
Aphthous Stomatitis, basil extract, endocan marker
Brief summary
A randomized double-blind placebo controlled trial will be carried out on 20 patients complaining from aphthus ulcer and 10 patient healthy control 10 patients treated with mucoadhesive gel containing 2% of basil extract 4 times per day (test group) for 20 min after every meal and before going to bed. The other 10 patients treated by mucoadhesive gel without drug which was used as placebo (composed from 6% w/w PVA (Mw = 31-50 kDa, 98-99% hydrolysed) and 2% w/w sodium tetraydroxy borate) 4 times per day 10 healthy patients will be selected to participate in the study to test the salivary level of endocan in the healthy individuals (negative control group)
Detailed description
A randomized double-blind placebo controlled trial will be carried out on 20 patients complaining from aphthus ulcer and 10 patient healthy control. Inclusion criteria will be: (i) age \> 18 years; (ii) a clear history of RAS(recurrent apthous stomatitis)occurring no less than four times a year; (iii) presentation with one or two ulcers measuring 10 mm in diameter for 48 hours and yet to receive treatment; (iv) ulcers that took \> 5 days to resolve without treatment. Individuals will excluded if they: (i) had underlying systemic disease(s) or a history of immunologic disorder(s); (ii) were taking immunomodulatory agents or systemic nonsteroidal anti-inflammatory drugs \< 1 month before study commencement; (iii) are smokers; (iv) are pregnant; (v) had a history of abusing drugs or alcohol; (vi) could not provide written informed consent. 10 patients treated with mucoadhesive gel containing 2% of basil extract 4 times per day (test group) for 20 min after every meal and before going to bed. The other 10 patients treated by mucoadhesive gel without drug which was used as placebo (composed from 6% w/w PVA (Mw = 31-50 kDa, 98-99% hydrolysed) and 2% w/w sodium tetraydroxy borate) 4 times per day 10 healthy patients will be selected to participate in the study to test the salivary level of endocan in the healthy individuals (negative control group)
Interventions
DRUGuse of basil extract gel in treatment of aphthus ulcer
This study aimed to evaluate the efficacy of basil extract (Ocimum basilicum) in the treatment of aphthous ulcers
OTHERmuco adhesive placebo gel
mucoadhesive gel without drug which was used as placebo (contains tragacanth gum, alcohol, sodium benzoate, and distilled water) 4 times per day
OTHERno treatment
(i) had underlying systemic disease(s) or a history of immunologic disorder(s); (ii) were taking immunomodulatory agents or systemic nonsteroidal anti-inflammatory drugs \< 1 month before study commencement; (iii) are smokers; (iv) are pregnant; (v) had a history of abusing drugs or alcohol; (vi) could not provide written informed consent.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* age \> 18 years; * a clear history of RAS (recurrent apthous stomatitis) occurring no less than four times a year; * presentation with one or two ulcers measuring 10 mm in diameter for 48 hours and yet to receive treatment; * ulcers that took \> 5 days to resolve without treatment.
Exclusion criteria
* had underlying systemic disease(s) or a history of immunologic disorder(s); * were taking immunomodulatory agents or systemic nonsteroidal anti-inflammatory drugs \< 1 month before study commencement; * are smokers; * are pregnant; * had a history of abusing drugs or alcohol; * could not provide written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pain score VAS (Visual Analogue Scale) | one week | The patients will be asked to record the daily level of pain severity of the ulcers through VAS (Visual Analogue Scale). It consisted of a 10-cm horizontal line, and the end of the line is (0) indicating no pain and the other end is (10) denoting unbearable pain. |
| healing duration | one week | patient evaluated by how long the ulcer takes to heal from baseline |
| size of the ulcer | one week | measuring the ulcer size at baseline,5 days, and one week |
| salivary endocan level | one week | enzyme-linked immunosorbent assays to measure the salivary concentrations of endocan marker at the first visit (i.e., before treatment) and the other was just after healing |
Countries
Egypt
Contacts
Primary Contactmalak m shoukheba
Backup Contactmalak m shoukheba
Outcome results
None listed