Efficacy of Adhesive Tablets in Treating Oral Ulcers (Aphthous)

This study has suspended participant recruitment.
(The company which holds the patent was not interested.)
Sponsor:
Collaborator:
Grant from "Axiomedic. Advanced Medical Solutions", Zurich, Switzerland
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00281723
First received: January 24, 2006
Last updated: May 6, 2007
Last verified: May 2007
  Purpose

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.


Condition Intervention Phase
Ulcer, Aphthous
Drug: Pro-Pe adhesive tablet
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Study of Efficacy of Adhesive Tablets in Treating Oral Ulcers (Aphthous)

Further study details as provided by Hadassah Medical Organization:

Primary Outcome 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.

Estimated Enrollment: 50
Estimated Study Completion Date: May 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00281723

Locations
Israel
Hadassah Medical Organization,
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Grant from "Axiomedic. Advanced Medical Solutions", Zurich, Switzerland
Investigators
Principal Investigator: Rakefet Czerninski, DMD Hebrew University-Hadassah School of Dental Medicine
Principal Investigator: Sharon Elad, DMD MSc Hebrew University-Hadassah School of Dental Medicine
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00281723     History of Changes
Other Study ID Numbers: 6-12.2.06-HMO-CTIL
Study First Received: January 24, 2006
Last Updated: May 6, 2007
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
Aphthous
oral

Additional relevant MeSH terms:
Stomatitis, Aphthous
Ulcer
Oral Ulcer
Stomatitis
Mouth Diseases
Stomatognathic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 15, 2014