Efficacy of Adhesive Tablets in Treating Oral Ulcers (Aphthous)

May 6, 2007 updated by: Hadassah Medical Organization

Phase 2 Study of Efficacy of Adhesive Tablets in Treating Oral Ulcers (Aphthous)

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel, 91120
        • Hadassah Medical Organization,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Anticipated)

May 1, 2007

Study Registration Dates

First Submitted

January 24, 2006

First Submitted That Met QC Criteria

January 24, 2006

First Posted (Estimate)

January 25, 2006

Study Record Updates

Last Update Posted (Estimate)

May 8, 2007

Last Update Submitted That Met QC Criteria

May 6, 2007

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6-12.2.06-HMO-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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