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

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.

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.

Study Overview

• Status: Completed
• Conditions: Aphtous Ulcers
• Intervention / Treatment: Drug: Bismu-Jet; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Valinhos, SP, Brazil, 13270000
      • LAL Clínica Pesquisa e Desenvolvimento Ltda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	V0 - 1st day, V1 - 3st day, V2 - 7th day, V3 - 14th day

Secondary Outcome Measures

Outcome Measure	Time Frame
safety will be assessed by the incidence of adverse reactions	V0 - 1st day, V1 - 3st day, V2 - 7th day, V3 - 14th day

Collaborators and Investigators

• Sponsor: Azidus Brasil

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (ACTUAL): June 1, 2011
• Study Completion (ACTUAL): November 1, 2011

Study Registration Dates

• First Submitted: March 6, 2009
• First Submitted That Met QC Criteria: March 6, 2009
• First Posted (ESTIMATE): March 9, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): February 25, 2013
• Last Update Submitted That Met QC Criteria: February 22, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: bismuth; aphtous; procain; neomycin; Efficacy of the Association in Treatment of Aphtous
• Additional Relevant MeSH Terms: Pathologic Processes; Ulcer
• Other Study ID Numbers: BNPEMS0209