Efficacy of Adhesive Tablets in Treating Oral Ulcers (Aphthous)

Sponsor

Hadassah Medical Organization (Other)

Overall Status

Suspended

CT.gov ID

NCT00281723

Collaborator

Grant from "Axiomedic. Advanced Medical Solutions", Zurich, Switzerland (Other)

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ulcer, Aphthous	Drug: Pro-Pe adhesive tablet	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Completion Date :

May 1, 2007

Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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

Locations

	Site	City	State	Country	Postal Code
1	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