Ulcer, Aphthous
Conditions
Keywords
Aphthous, oral
Brief summary
Recurrent Aphthous Stomatitis (RAS) of the oral mucosa is a common and painful condition. Despite advances in therapeutic means there is still necessary to find a way to alleviate the local pain and discomfort induced by the mucosal ulceration. The hypothesis was to study the effectiveness and acceptance of a herbal adhesive tablets in the treatment of RAS. Participants in the study will be examined for oral lesions, will be instructed how to apply the oral-tablet, and will be interviewed during the follow-up period up to one week after the application.
Interventions
DRUGPro-Pe adhesive tablet
Sponsors
Grant from Axiomedic. Advanced Medical Solutions, Zurich, Switzerland
Hadassah Medical Organization
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
(in healthy individuals): * Age above 18 years old. * Non-pregnant women. * Healthy or controlled chronic diseases. * Examination at the Oral Medicine Clinic Inclusion Criteria (in RAS patients): * Age above 18 years old. * Non-pregnant women. * Clinical diagnosis of RAS. * Examination at the Oral Medicine Clinic
Exclusion criteria
* Oral lesion suspected to be malignant. * Ulcerative oral lesion other than RAS. * Another experimental oral intervention within the last 24 hours. * Pregnant women. * Allergy to components of the Pro-pe adhesive tablet
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serial questionnaires within 1 week post treatment to assess patient's perception, patient's pain relief and local adverse events in comparison to his past experience with other local treatments for oral ulcers. | — |
Countries
Israel
Outcome results
None listed