Efficacy of Adhesive Tablets in Treating Oral Ulcers (Aphthous)

Overview

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.

Full Title of Study: “Phase 2 Study of Efficacy of Adhesive Tablets in Treating Oral Ulcers (Aphthous)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)

Interventions

  • Drug: Pro-Pe adhesive tablet

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Investigator Details

  • Lead Sponsor
    • Hadassah Medical Organization
  • Collaborator
    • Grant from “Axiomedic. Advanced Medical Solutions”, Zurich, Switzerland
  • Overall Official(s)
    • Rakefet Czerninski, DMD, Principal Investigator, Hebrew University-Hadassah School of Dental Medicine
    • Sharon Elad, DMD MSc, Principal Investigator, Hebrew University-Hadassah School of Dental Medicine

References

Mizrahi B, Golenser J, Wolnerman JS, Domb AJ. Adhesive tablet effective for treating canker sores in humans. J Pharm Sci. 2004 Dec;93(12):2927-35. doi: 10.1002/jps.20193.

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