Efficacy of Adhesive Tablets in Treating Oral Ulcers (Aphthous)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2007-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ulcer, Aphthous

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Pro-Pe adhesive tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age above 18 years old.
* Non-pregnant women.
* Healthy or controlled chronic diseases.
* Examination at the Oral Medicine Clinic

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Rakefet Czerninski, DMD

Role: PRINCIPAL_INVESTIGATOR

Hebrew University-Hadassah School of Dental Medicine

Sharon Elad, DMD MSc

Role: PRINCIPAL_INVESTIGATOR

Hebrew University-Hadassah School of Dental Medicine

Locations

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Hadassah Medical Organization,

Jerusalem, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type BACKGROUND

PMID: 15459950 (View on PubMed)

Other Identifiers

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6-12.2.06-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id