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Completed

NCT Number: NCT00857688

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

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.

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Key information

Conditions

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

LAL Clinica Pesquisa e Desenvolvimento Ltda

Valinhos, São Paulo, 13270000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bismu-Jet

Drug

Bismuth sodium tartrate, neomycin sulfate, procain hydrocloride

Placebo

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Azidus Brasil

Industry

Registry information

Official study 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.

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Mar 9, 2009
Registry last updated
Feb 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.