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Evaluation of the use of artificial saliva to prevent mouth lesions in patients admitted to an intensive care unit

Evaluation of the effectiveness of the use of artificial saliva in the prevention of oral changes in patients admitted to an intensive care unit

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-10fqpzdg
Enrollment
Unknown
Registered
2025-08-28
Start date
2024-10-01
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

Xerostomia

Interventions

This is an single-blind, two-arm randomized controlled clinical trial. A total of 58 individuals who meet the eligibility criteria will be allocated to either the experimental or control group, based
D25.583.820

Sponsors

Departamento de Odontologia da Universidade Federal do Rio Grande do Norte - Lagoa Nova Campus Central
Lead Sponsor
Hospital Geral João Machado
Collaborator
Universidade Federal do Rio Grande do Norte - Lagoa Nova Campus Central
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients over 18 years of age; of both sexes; patients undergoing dental examination within the first 24 hours of admission to the Intensive Care Unit; patients with no history of autoimmune diseases; without sepsis; without current pregnancy; without known sensitivity to ingredients of the gel used; without evident oral or perioral changes or lesions on examination upon admission to the Intensive Care Unit; patients totally dependent on professional care

Exclusion criteria

Exclusion criteria: Patients whose oral examination cannot be performed (limitation of mouth opening or other factor); patients who were already hospitalized in the Intensive Care Unit of another service

Design outcomes

Primary

MeasureTime frame
It is expected to evaluate whether the daily use of artificial saliva is capable of preventing dry mouth during the stay in the ICU, verified by analyzing the daily exams using the dry mouth index, based on the finding of a variation of at least 5% in the areas between the experimental and control groups

Secondary

MeasureTime frame
It is expected to evaluate whether the daily use of artificial saliva is capable of preventing frequent oral lesions during the stay in the ICU (such as traumatic ulcers), verified by the analysis of daily exams using the oral mucosa health index, based on the finding of a variation of at least 5% in the areas between the experimental and control groups;It is expected to evaluate whether the daily use of artificial saliva is capable of preventing oral candidiasis during the stay in the ICU (such as traumatic ulcers), verified by the analysis of daily exams through clinical examination by trained professionals, based on the finding of a variation of at least 5% in the areas between the experimental and control groups

Countries

Brazil

Contacts

Public ContactEdmundo Martins

Universidade Federal do Rio Grande do Norte

edmundoduarte0@gmail.com+55 (084) 998700246

Outcome results

None listed

Source: REBEC (via WHO ICTRP)