Efficacy of Adhesive Tablets in Treating Oral Ulcers (Aphthous)

Hadassah Medical Center

Status and phase: Suspended; Phase 2

Conditions: Ulcer, Aphthous

Treatments: Drug: Pro-Pe adhesive tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT00281723

6-12.2.06-HMO-CTIL

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)