Status:
COMPLETED
Efficacy of the Combination Bismuth + Neomycin + Procaine in the Treatment of Recurrent Aphthous Ulceration
Lead Sponsor:
Azidus Brasil
Conditions:
Aphtous Ulcers
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
To evaluate the efficacy of the product Bismu-Jet ® (bismuth tartrate and sodium, neomycin sulfate and procaine hydrochloride) produced by EMS S / A compared to placebo in reducing the signs and sympt...
Detailed Description
The period of practical study will be conducted at the Center for Orofacial Rehabilitation Aesthetics, located in Campinas-SP, where there are several beds and a large number of people served by denti...
Eligibility Criteria
Inclusion
- Consistency with the purposes of the study and all topics of FICT;
- Age above 12 years;
- Both sexes;
- Diagnosis of type UAR minor
Exclusion
- Use of nutritional supplements such as iron, folic acid and vitamins of the B complex;
- immunocompromised;
- systemic diseases (endocrine-metabolic);
- rheumatic diseases;
- Pregnancy and lactation;
- Use of topical or systemic corticosteroids;
- UAR type major;
- UAR type Herpetiformis;
- UAR over 48 hours of development;
- Background allergic to any components of the formula.
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00857688
Start Date
May 1 2011
End Date
November 1 2011
Last Update
February 25 2013
Active Locations (1)
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1
LAL Clinica Pesquisa e Desenvolvimento Ltda
Valinhos, São Paulo, Brazil, 13270000