Critically IllNCT07831564
Professional Oral Care and Staff Education in Critically Ill Patients
A study testing Professional Oral Care, Standard Oral Care and ICU Staff Oral Care Education in people with Critically Ill and Oral Health Care, run by Semmelweis University at 2 sites in Hungary.
Trial summary
This study evaluated oral health in critically ill patients admitted to two intensive care units in Budapest, Hungary, and examined whether professional oral care and education of intensive care staff could improve oral hygiene. A total of 161 adult patients were included. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill, Oral Health Care, Critical Illness
- What is being tested?
- Professional Oral Care, Standard Oral Care and ICU Staff Oral Care Education
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 2 sitesHungary
- Study dates
- 15 Jun 2023to 9 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (≥18 years of age) admitted to one of the participating intensive care units.
- Expected ICU stay of at least 48 hours.
- Informed consent obtained from the patient or their legally authorized representative.
Who cannot join
- ICU stay shorter than 48 hours.
- Refusal to participate or inability to obtain informed consent from the patient or their legally authorized representative.
- Conditions associated with a high risk of bleeding that contraindicated oral examination or oral care.
Trial locations and contacts
2 sites in 1 country.
Hungary2 sites
Dr. Manninger Jenő National Trauma Center
Budapest, 1081
Bajcsy-Zsilinszky Hospital
Budapest, 1106
About this study
Official title: Professional Oral Care and Staff Education to Improve Oral Hygiene in Critically Ill Patients: A Prospective Controlled Clinical Study
This study evaluated oral health in critically ill patients admitted to two intensive care units in Budapest, Hungary, and examined whether professional oral care and education of intensive care staff could improve oral hygiene. A total of 161 adult patients were included. Dentate patients in the first phase were randomly assigned to receive either professional oral care provided by dentists or standard oral care provided by ICU nursing staff. Total edentulous patients were included in a separate group. After a structured oral care education programme was provided to ICU staff, subsequently enrolled patients were included in a separate post-education group. Oral hygiene and gingival inflammation were assessed repeatedly during the ICU stay.
- Being tested
- Professional Oral Care, Standard Oral Care, ICU Staff Oral Care Education
- Keywords
- oral hygiene, oral care, critical illness, intensive care, orotracheal intubation, gingivitis, ventilator-associated pneumonia, staff education
- Medical subject headings
- Critical Illness, Gingivitis, Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Professional Oral CareBehavioural
Professional oral care was provided by calibrated dentists three times weekly using a rotary-oscillatory electric toothbrush and fluoride toothpaste. Cleaning included the occlusal, buccal, and lingual tooth surfaces, followed by oral rinsing with sterile water.
Standard Oral CareBehavioural
Standard oral care was provided by ICU nursing staff twice daily according to local clinical practice. At the Bajcsy-Zsilinszky Hospital ICU, care consisted of toothbrushing or oral swabbing with a non-chlorhexidine antiseptic solution. At the Trauma Center ICU, care consisted of chlorhexidine mouth rinsing combined with toothbrushing.
ICU Staff Oral Care EducationBehavioural
A structured educational programme was provided to ICU physicians and nurses. The programme addressed oral hygiene, current recommendations for the prevention of ventilator-associated pneumonia, and the recommended oral care protocol, including toothbrushing with toothpaste and oral rinsing. Patients enrolled after completion of the education programme constituted the post-education (upskill) group.
| Study group | Role | What they receive |
|---|---|---|
| Professional Oral Care | Experimental | Dentate patients randomly assigned during the first study phase to receive professional oral care provided by calibrated dentists three times weekly. Oral care was performed using a rotary-oscillatory electric toothbrush and fluoride toothpaste, including cleaning of occlusal, buccal, and lingual tooth surfaces, followed by oral rinsing with sterile water. Receives: Behavioral: Professional Oral Care |
| Standard oral care | Active comparator | Dentate patients randomly assigned during the first study phase to receive standard oral care provided by ICU nursing staff according to local clinical practice. Standard care was performed twice daily. Receives: Behavioral: Standard Oral Care |
| Upskill | Experimental | Dentate patients enrolled after implementation of a structured staff education programme. The programme addressed oral hygiene, recommendations for prevention of ventilator-associated pneumonia, and the recommended oral care protocol, including toothbrushing with toothpaste and oral rinsing. Patients subsequently received standard oral care according to local ICU practice. Receives: Behavioral: Standard Oral Care; Behavioral: ICU Staff Oral Care Education |
| Total edentulous | Other | Total edentulous patients included in a separate non-randomized cohort. These patients received standard oral care according to local ICU practice. Receives: Behavioral: Standard Oral Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Simplified Oral Hygiene Index (OHI-S) over time
Oral hygiene was assessed using the Simplified Oral Hygiene Index (OHI-S), which ranges from 0 to 6, with higher scores indicating poorer oral hygiene. OHI-S scores were compared between study groups and across repeated examinations during the ICU stay.
Measured: Baseline and three times weekly during the ICU stay, through ICU discharge, an average of 30 days.
Secondary outcomes (6)
Change in gingivitis prevalence over time
Gingival inflammation was assessed clinically at each oral examination. Gingivitis prevalence was compared between study groups and across repeated examinations during the ICU stay.
Measured: Baseline and three times weekly during the ICU stay, through ICU discharge, an average of 30 days.
Incidence of ventilator-associated pneumonia (VAP)
Occurrence of VAP during the ICU stay, recorded as a dichotomous outcome (yes/no) at the end of the ICU stay. VAP was defined according to the diagnostic criteria used in the participating ICUs, including onset at least 48 hours after initiation of mechanical ventilation.
Measured: Through ICU discharge, an average of 30 days.
Duration of mechanical ventilation
Duration of invasive mechanical ventilation, measured in days from initiation of mechanical ventilation until discontinuation or death, whichever occurred first.
Measured: From initiation of invasive mechanical ventilation until discontinuation or death, whichever occurred first, assessed up to 43 days.
ICU length of stay
Duration of the intensive care unit stay, measured in days from ICU admission until ICU discharge or death, whichever occurred first.
Measured: From ICU admission until ICU discharge or death, whichever occurred first, assessed up to 66 days.
Hospital length of stay
Duration of hospital stay, measured in days from hospital admission until hospital discharge or death, whichever occurred first.
Measured: From hospital admission until hospital discharge or death, whichever occurred first, assessed up to 103 days.
All-cause mortality
All-cause mortality during hospitalization, recorded as a dichotomous outcome (yes/no).
Measured: Up to 103 days after ICU admission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start15 Jun 2023
- Primary completion14 Mar 2025
- Study completion9 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically IllStudies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study comprised two sequential phases. During the first phase, dentate patients were randomly assigned to parallel intervention or control groups, while total edentulous patients were included in a separate non-randomized cohort. Following a structured staff education programme, subsequently enrolled patients were included in a separate post-education cohort.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Szandra K Körmendi, PhD, DMD, Principal investigator, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07831564
- Sponsor's protocol ID
- 97-2023
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Professional Oral Care and Staff Education to Improve Oral Hygiene in Critically Ill Patients: A Prospective Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT07831564
- Acronym / sponsor ID
- 97-2023
- Keywords
- oral hygiene, oral care, critical illness, intensive care, orotracheal intubation, gingivitis, ventilator-associated pneumonia, staff education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 14 Mar 2025 (actual)
- Study completion
- 9 Sep 2025 (actual)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluated oral health in critically ill patients admitted to two intensive care units in Budapest, Hungary, and examined whether professional oral care and education of intensive care staff could improve oral hygiene. A total of 161 adult patients were included. Dentate patients in the first phase were randomly assigned to receive either professional oral care provided by dentists or standard oral care provided by ICU nursing staff. Total edentulous patients were included in a separate group. After a structured oral care education programme was provided to ICU staff, subsequently enrolled patients were included in a separate post-education group. Oral hygiene and gingival inflammation were assessed repeatedly during the ICU stay.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- The study comprised two sequential phases. During the first phase, dentate patients were randomly assigned to parallel intervention or control groups, while total edentulous patients were included in a separate non-randomized cohort. Following a structured staff education programme, subsequently enrolled patients were included in a separate post-education cohort.
| Arm | Type | Receives |
|---|---|---|
| Professional Oral Care | Experimental | Behavioral: Professional Oral CareDentate patients randomly assigned during the first study phase to receive professional oral care provided by calibrated dentists three times weekly. Oral care was performed using a rotary-oscillatory electric toothbrush and fluoride toothpaste, including cleaning of occlusal, buccal, and lingual tooth surfaces, followed by oral rinsing with sterile water. |
| Standard oral care | Active comparator | Behavioral: Standard Oral CareDentate patients randomly assigned during the first study phase to receive standard oral care provided by ICU nursing staff according to local clinical practice. Standard care was performed twice daily. |
| Upskill | Experimental | Behavioral: Standard Oral Care, Behavioral: ICU Staff Oral Care EducationDentate patients enrolled after implementation of a structured staff education programme. The programme addressed oral hygiene, recommendations for prevention of ventilator-associated pneumonia, and the recommended oral care protocol, including toothbrushing with toothpaste and oral rinsing. Patients subsequently received standard oral care according to local ICU practice. |
| Total edentulous | Other | Behavioral: Standard Oral CareTotal edentulous patients included in a separate non-randomized cohort. These patients received standard oral care according to local ICU practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (≥18 years of age) admitted to one of the participating intensive care units.
- Expected ICU stay of at least 48 hours.
- Informed consent obtained from the patient or their legally authorized representative.
Key exclusion criteria (3 listed)
- ICU stay shorter than 48 hours.
- Refusal to participate or inability to obtain informed consent from the patient or their legally authorized representative.
- Conditions associated with a high risk of bleeding that contraindicated oral examination or oral care.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Professional Oral CareProfessional oral care was provided by calibrated dentists three times weekly using a rotary-oscillatory electric toothbrush and fluoride toothpaste. Cleaning included the occlusal, buccal, and lingual tooth surfaces, followed by oral rinsing with sterile water. | Behavioural | Professional Oral Care |
| Standard Oral CareStandard oral care was provided by ICU nursing staff twice daily according to local clinical practice. At the Bajcsy-Zsilinszky Hospital ICU, care consisted of toothbrushing or oral swabbing with a non-chlorhexidine antiseptic solution. At the Trauma Center ICU, care consisted of chlorhexidine mouth rinsing combined with toothbrushing. | Behavioural | Standard oral care, Total edentulous, Upskill |
| ICU Staff Oral Care EducationA structured educational programme was provided to ICU physicians and nurses. The programme addressed oral hygiene, current recommendations for the prevention of ventilator-associated pneumonia, and the recommended oral care protocol, including toothbrushing with toothpaste and oral rinsing. Patients enrolled after completion of the education programme constituted the post-education (upskill) group. | Behavioural | Upskill |
Primary outcome
Change in Simplified Oral Hygiene Index (OHI-S) over time
Time frame: Baseline and three times weekly during the ICU stay, through ICU discharge, an average of 30 days.
Oral hygiene was assessed using the Simplified Oral Hygiene Index (OHI-S), which ranges from 0 to 6, with higher scores indicating poorer oral hygiene. OHI-S scores were compared between study groups and across repeated examinations during the ICU stay.
6 secondary outcomes
Change in gingivitis prevalence over time
Time frame: Baseline and three times weekly during the ICU stay, through ICU discharge, an average of 30 days.
Incidence of ventilator-associated pneumonia (VAP)
Time frame: Through ICU discharge, an average of 30 days.
Duration of mechanical ventilation
Time frame: From initiation of invasive mechanical ventilation until discontinuation or death, whichever occurred first, assessed up to 43 days.
ICU length of stay
Time frame: From ICU admission until ICU discharge or death, whichever occurred first, assessed up to 66 days.
Hospital length of stay
Time frame: From hospital admission until hospital discharge or death, whichever occurred first, assessed up to 103 days.
All-cause mortality
Time frame: Up to 103 days after ICU admission.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Critically Ill
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Szandra K Körmendi, PhD, DMD principal investigator
Semmelweis University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Professional Oral Care, Standard Oral Care and ICU Staff Oral Care Education in people with Critically Ill and Oral Health Care, run by Semmelweis University at 2 sites in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Simplified Oral Hygiene Index (OHI-S) over time (time frame: Baseline and three times weekly during the ICU stay, through ICU discharge, an average of 30 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.