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Can a dental care intervention reduce the risk of death of patients treated in intensive care units? A clinical randomized study

Can a dental care intervention reduce the risk of death among critical patients? A cluster randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-4jmz36
Enrollment
Unknown
Registered
2018-07-10
Start date
2018-11-02
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Death attributable to nosocomial lower respiratory-tract infections among adults and elderly patients admitted to intensive care units (ICUs) and to evaluate if dental treatment reduces the occurrence of major cardiovascular events after discharge from the ICU in a subgroup of patients with a high cardiovascular risk. Respiratory Infections

Interventions

The patients alocated in the experimental group (n=928) will be attended by a dental surgeon at least three times per week in order to promote adequate cleaning of the oral cavity, including teeth, to
Procedure/surgery

Sponsors

Departamento de Medicina Social da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Lead Sponsor
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Collaborator

Eligibility

Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: The intention to treat study population will consist of any patient with ages between 18 to 100 years old admitted for ICU admission during the study period. Subsequently, in the data analysis, those who remain hospitalized for at least 72 hours and have received at least two dental treatment sessions will be considered a per protocol subpopulation.

Exclusion criteria

Exclusion criteria: Patients who cross the washout period, ie remain in the ICU after the interval of 1 month between the alternation of intervention to control conglomerates and vice-versa, will be excluded from the study. This exclusion will only be from the database for analysis. This does not imply the interruption of dental care if the patient needs it.

Design outcomes

Primary

MeasureTime frame
Reduction of the overall risk of global death and death attributable to nosocomial infections of the lower respiratory tract between adult and elderly patients admitted to ICUs. The relative risk of overall death and attributable to nosocomial infections of the lower respiratory tract between adult and elderly patients admitted to ICUs will be calculated based on the study allocation, whether in the control group or in the experimental group. Patients will be followed up and the outcome evaluated at the time of ICU patient exit by calculation of APACHE II score.

Secondary

MeasureTime frame
The incidence of lower respiratory-tract infections,the survival time free from lower respiratory-tract infections in the ICU, the length of mechanical ventilation, the duration of antimicrobial treatment, and the length of stay in the ICU. These data will be collected daily, through prospective observation and evaluation of the records contained in the medical records, through prospective observation until the moment the patient is discharged from the ICU or death occurs. To assess whether dental treatment administered during hospitalization for an acute cardiovascular event in an ICU can lead to a reduction in subsequent major cardiovascular events (new nonfatal infarction, death from cardiovascular cause, stroke, transient ischemic attack, new unplanned revascularization and hospitalization for heart failure) during prospective follow-up (at intervals of 30 days, 90 days, 6 months and 1 year). The patient, after discharge from the ICU, will be contacted and evaluated prospectively for the investigation of cardiovascular events by a cardiologist.

Countries

Brazil

Contacts

Public ContactIsabella Lima Ribeiro

Departamento de Medicina Social da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

isabella_arrais@yahoo.com+55-016-997183183

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 19, 2026