RBR-3hh8kxq Analysis of bad breath in individuals with bone necrosis in the jaws

Date of registration: 03/27/2022 ^(mm/dd/yyyy)
Last approval date : 03/27/2022 ^(mm/dd/yyyy)

Study type:

Observational

Scientific title:

Trial identification

• UTN code: U1111-1267-1833

• Public title:

  en

  Analysis of bad breath in individuals with bone necrosis in the jaws

  pt-br

  Análise do mau hálito em indivíduos com necrose óssea nos maxilares

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 31129020.4.0000.5417
    Issuing authority: Plataforma Brasil
  • 4.239.336
    Issuing authority: Parecer consubstanciado do Comitê de Ética em Pesquisa da Universidade de São Paulo

Sponsors

• Primary sponsor: Universidade de São Paulo - Campus Bauru
• Secondary sponsor:
  • Institution: Universidade de São Paulo - Campus Bauru
• Supporting source:
  • Institution: Universidade de São Paulo - Campus Bauru

Health conditions

• Health conditions:

  en

  Medication related osteonecrosis of the Jaw

  pt-br

  Osteonecrose dos maxilares associada a medicamentos

• General descriptors for health conditions:

  en

  M87 Osteonecrosis

  pt-br

  M87 Osteonecrose

• Specific descriptors:

  en

  M87.1 Medication related osteonecrosis of the jaw

  pt-br

  M87.1 Osteonecrose devido a drogas

Interventions

• Interventions:

  en

  A case-control study will be carried out with a total of 40 participants, 20 in the study group and 20 in the control group. The aim of this study is to identify, quantify and discover the origin of volatile sulfur compounds using the OralChroma™ gas chromatograph in individuals with medication-related osteonecrosis of the jaw and to associate it with the staging of medication-related osteonecrosis of the jaw.

  pt-br

  Será realizado um estudo caso-controle composto por um total de 40 participantes, sendo 20 no grupo de estudo e 20 grupo controle. O objetivo deste estudo é identificar, quantificar e descobrir a origem dos compostos sulfurados voláteis através do cromatógrafo gasoso OralChroma™ em indivíduos com Osteonecrose dos maxilares associados a medicamentos e associar com o estadiamento da osteonecrose dos maxilares associada a medicamentos

• Descriptors:

  en

  SP4.051.512 Diagnosis

  pt-br

  SP4.051.512 Diagnóstico

Recruitment

• Study status: Recruiting
• Countries
  • Brazil
• Date first enrollment: 06/14/2021 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  40	-	18 Y	0

• Inclusion criteria:

  en

  Individuals over 18 years of age with a confirmed diagnosis of medication; related osteonecrosis of the Jaw according to clinical and imaging criteria according to the American Association of Oral and Maxillofacial Surgeons Annual Meeting; who are being monitored at the Clinical Research Center University of São Paulo Bauru

  pt-br

  Indivíduos maiores de 18 anos com diagnóstico confirmado de osteonecrose dos maxilares associados a medicamentos segundo os critérios clínicos e imaginológicos segundo a Americana dos Cirurgiões Maxillofaciais; que estejam em acompanhamento no Centro de Pesquisa Clínica da Universidade de São Paulo Bauru

• Exclusion criteria:

  en

  History of head and neck cancer and undergoing radiotherapy in the head and neck region; current diagnosis of infection in the upper and or lower respiratory tract; gastric reflux; pregnancy; lactation; liver failure; individuals undergoing hemodialysis; individuals with a history of diseases that may pose a risk to themselves or to the evaluator such as sarcoidosis tuberculosis severe heart disease drug or alcohol abuse graft versus host disease

  pt-br

  Histórico de câncer de cabeça e pescoço e submetidos à radioterapia em região de cabeça e pescoço; diagnóstico atual de infecção no trato respiratório superior e ou inferior; refluxo gástrico; gestação; lactação; insuficiência hepática; indivíduos que realizam hemodiálise; indivíduos com histórico doenças que possam trazer risco a ele mesmo ou ao avaliador como sarcoidose tuberculose cardíaco grave abuso de drogas ou etilismo doença do enxerto versus hospedeiro

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase

Outcomes

• Primary outcomes:

  en

  Identify and quantify the origin of volatile sulfur compounds in individuals with Medication-Related Osteonecrosis of the Jaw and associate it with Medication-Related Osteonecrosis of the Jaw staging

  pt-br

  Identificar e quantificar a origem dos compostos sulfurados voláteis em indivíduos com Osteonecrose dos Maxilares Associados a Medicamentos e associar com o estadiamento da Osteonecrose dos Maxilares Associados a Medicamentos

• Secondary outcomes:

  en

  Secondary outcomes are not expected

  pt-br

  Não são esperados desfechos secundários

Contacts

• Public contact
  • Full name: Paulo Sérgio da Silva Santos
  • • Address: Alameda Otavio Pinheiro Brisolla, n° 9-75
    • City: Bauru / Brazil
    • Zip code: 17012-901
  • Phone: +55-14-32266113
  • Email: paulosergiosilvasantos@gmail.com
  • Affiliation: Universidade de São Paulo - Campus Bauru
   
• Scientific contact
  • Full name: Paulo Sérgio da Silva Santos
  • • Address: Alameda Otavio Pinheiro Brisolla, n° 9-75
    • City: Bauru / Brazil
    • Zip code: 17012-901
  • Phone: +55-14-32266113
  • Email: paulosergiosilvasantos@gmail.com
  • Affiliation: Universidade de São Paulo - Campus Bauru
   
• Site contact
  • Full name: Paulo Sérgio da Silva Santos
  • • Address: Alameda Otavio Pinheiro Brisolla, n° 9-75
    • City: Bauru / Brazil
    • Zip code: 17012-901
  • Phone: +55-14-32266113
  • Email: paulosergiosilvasantos@gmail.com
  • Affiliation: Universidade de São Paulo - Campus Bauru
   

Additional links:

• Download in ICTRP format