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CompletedNCT05575050Updated Oct 12, 2022

Impact of Teeth Brushing in Ventilated COVID-19 Patients.

An interventional study of Oral Procedure in Microbial Colonization, COVID-19 Respiratory Infection and Dysbiosis, sponsored by University Hospital in Krakow. Completed at 1 site in Poland. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-10-12.

Sponsored by University Hospital in Krakow · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Sep 2021, registered Oct 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Non-randomized
Ages
18 Years to 90 Years
Sex
All
01

Study summary

The aims of this study were:

  1. Observation of dynamics in oral microbiota and its association with the incidence of HAIs and VAP in mechanically ventilated COVID-19 patients in an ICU setting
  2. Evaluation of the incidence of HAIs and VAP and their association with oral bacteriobiota in mechanically ventilated COVID-19 patients in an ICU setting
  3. Assessment of impact of different oral hygienic procedures on oral microbiota, the incidence of HAI and patients' safety in mechanically ventilated COVID-19 patients in an ICU setting approaches to oral care in an ICU setting

Intervention of oral hygienic procedures implemented in study:

Patients were divided into 2 groups depending on the oral care procedure:

  1. Standard oral procedure (cleaning and moisturizing of oral cavity, suction of excess fluid)
  2. Extended oral procedure (cleaning and moisturizing of oral cavity, teeth brushing, suction of excess fluid)
02

Conditions studied

  • Microbial Colonization
  • COVID-19 Respiratory Infection
  • Dysbiosis
  • VAP - Ventilator Associated Pneumonia
  • HAI

Keywords

  • oral microbiota
  • healthcare-associated infection
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 56 is below the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

University Hospital in Krakow is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • SARS-CoV-2 infection confirmed by real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay of nasal and pharyngeal swabs upon hospital admission
  • Signed consent to participate in the study
  • Patients admitted to ICU
  • Intubation due to COVID-19 related pneumonia and acute respiratory distress syndrome (ARDS) within 24 hours preceding study procedures

Exclusion criteria

Exclusion Criteria:

  • No consent to participate in the study
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
56 participants (actual)

Study arms

  • Active comparator
    Standard oral procedure

    Standard mouth cleaning protocol (without brushing) included: 1. Preparation of sterile catheter (12F lub 14F), suction of excess fluid from the oral cavity. 2. Using Sage Suction Swab (Toothette®), soaking in Perox-A-Mint Solution and cleaning with circular movements of each mucosal site for 10 seconds: 1. Right cheek mucosa and right upper quadrant 2. Left cheek mucosa and left upper quadrant 3. Left lower buccal quadrant 4. Right lower buccal quadrant 3. Moisturizing with Mouth Moisturizer /firma/ of oral cavity mucosa, tongue and lips. 4. Repeated suction of excess fluid from the oral cavity.

    Procedure: Oral Procedure

  • Active comparator
    Extended oral procedure

    Extended mouth cleaning protocol (with brushing) included: 1. Preparation of sterile catheter (12F lub 14F), suction of excess fluid from the oral cavity. 2. Teeth brushing (each teeth quadrant for 30) using Sage Untreated Suction Toothbrush (SUST) connected to suction unit, moistured with sterile water. 3. Using Sage Untreated Suction Toothbrush (SUST) moisturised with sterile water and cleaning with circular movements of each mucosal site for 10 seconds: 1. Right cheek mucosa and right upper quadrant 2. Left cheek mucosa and left upper quadrant 3. Left lower buccal quadrant 4. Right lower buccal quadrant 4. Moisturizing with Mouth Moisturizer of oral cavity mucosa, tongue and lips. 5. Repeated suction of excess fluid from the oral cavity.

    Procedure: Oral Procedure

Interventions

  • ProcedureOral Procedure

    Interventions included 2 variants of oral hygienic procedures. One was extended of teeth brushing.

06

What researchers measure

Primary outcomes

  1. Healthcare-associated infection

    Healthcare-associated infection (HAI) incidence was measured.

    Time frame: one month

Secondary outcomes

  1. Oral cavity assessment

    Using The Beck Oral Assessment Scale (BOAS)

    Time frame: one month

  2. Frequency of identification of Enterococcus fecalis, Acinetobacter baumannii, Klebsiella pneumoniae.

    Frequency of identification of Enterococcus fecalis, Acinetobacter baumannii, Klebsiella pneumoniae in different samples from oral cavity taken from ventilated COVID-19 patients on Intensive Care Unit.

    Time frame: one month

07

Study locations

1 site
  • Univeristy Hospital Kraków
    Cracovia, Poland
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 12, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05575050
Lead sponsor
University Hospital in Krakow
Responsible party
Mateusz Fiema (MD, University Hospital in Krakow) — Principal investigator
First posted
Oct 12, 2022
Start date
Sep 1, 2021
Primary completion
Jan 31, 2022
Completion
Jan 31, 2022
Last update
Oct 12, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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