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Efficacy of the Combination Bismuth + Neomycin + Procaine in the Treatment of Recurrent Aphthous Ulceration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00857688
Recruitment Status : Completed
First Posted : March 9, 2009
Last Update Posted : February 25, 2013
Information provided by:
Azidus Brasil

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 symptoms resulting from UAR in patients of both sexes, with age over 12 years.

Condition or disease Intervention/treatment Phase
Aphtous Ulcers Drug: Bismu-Jet Other: Placebo Phase 3

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 dentists attending post-graduate, under the supervision of Dr. Claudio Azenha. Thus, patients are instructed to find the center if they experience the first signs of UARs.

Will be included only where the top of the table has not extrapolated 48 hours. These patients will be referred to the visit of screening and early treatment (day 0 - Visit 01). At a screening visit will be informed all the relevant aspects of research, enabling the patient judge the feasibility of their participation in the study. After signing the Informed Consent, patients will be randomized and will receive one of the treatments. This consultation will be a clinical examination where the examiner will tell the lesions and measure the size of each. Besides the clinical examination there is a subjective test, in which the patient must consider the intensity of pain you're feeling at that moment, using the visual analogue scale (VAS). The drug will be administered by the investigator, the patient showing the correct way of administration. After 15 minutes, the pain will be measured again, using the VAS.

After three days, patients should return for the 02 tour, which will be clinically evaluated and will be assessed for intensity of pain, in addition to the reporting of adverse events. The same procedures will be repeated in the return of seven days (Visit 03). This visit some patients may receive high clinic.

The study will be finalized after 14 days of treatment (Visit 04), when patients must return to the office to the final evaluations, as will high or be exempted from the clinical study.

Patients who do not have improvement in time, receive replacement therapy funded by the sponsor and provided by waxen, according to the needs of each individual case, judged by expert researchers.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Clinical Study to Evaluate the Effectiveness and Safety of the Drug Topic Bismu-Jet ® (Bismuth Tartrate, Neomycin Sulphate and Procaine Hydrochloride) Compared to Placebo in Improvement of Signs and Symptoms of Ulcerations Caused Disease.
Study Start Date : May 2011
Actual Primary Completion Date : June 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 - Test
Patients will recieve the association.
Drug: Bismu-Jet
Bismuth sodium tartrate, neomycin sulfate, procain hydrocloride

Placebo Comparator: 2
Placebo: Menthol, saccharin sodium, propylene glycol, sodium hydroxide, glycerol, ethyl alcohol, water
Other: Placebo
Placebo: Menthol, saccharin sodium, propylene glycol, sodium hydroxide, glycerol, ethyl alcohol, water

Primary Outcome Measures :
  1. The pain will be assessed by visual analogue scale. Will evaluate the size of the lesion using a ruler created specifically for this study The number of lesions will be evaluated by counting. [ Time Frame: V0 - 1st day, V1 - 3st day, V2 - 7th day, V3 - 14th day ]

Secondary Outcome Measures :
  1. safety will be assessed by the incidence of adverse reactions [ Time Frame: V0 - 1st day, V1 - 3st day, V2 - 7th day, V3 - 14th day ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Consistency with the purposes of the study and all topics of FICT;
  • Age above 12 years;
  • Both sexes;
  • Diagnosis of type UAR minor

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00857688

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LAL Clinica Pesquisa e Desenvolvimento Ltda
Valinhos, SP, Brazil, 13270000
Sponsors and Collaborators
Azidus Brasil
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Responsible Party: Alexandre FRederico, LAL Clinica Identifier: NCT00857688    
Other Study ID Numbers: BNPEMS0209
First Posted: March 9, 2009    Key Record Dates
Last Update Posted: February 25, 2013
Last Verified: February 2013
Keywords provided by Azidus Brasil:
Efficacy of the Association in Treatment of Aphtous
Additional relevant MeSH terms:
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Pathologic Processes