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Efficacy of Adhesive Tablets in Treating Oral Ulcers (Aphthous)

Phase 2
Suspended
Conditions
Ulcer, Aphthous
Registration Number
NCT00281723
Lead Sponsor
Hadassah Medical Organization
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
SUSPENDED
Sex
All
Target Recruitment
50
Inclusion Criteria

Not provided

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 & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
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.
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Hadassah Medical Organization,

🇮🇱

Jerusalem, Israel

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