An interventional study of Professional Oral Care and Standard Oral Care in Critically Ill, Oral Health Care and Critical Illness, sponsored by Semmelweis University. Completed at 2 sites in Hungary. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Semmelweis University · Not applicable, Interventional, and Supportive care
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.
1,780 studies on the registry are indexed under Critical Illness; 442 are open to participants now.
This study's enrollment of 161 is above the median of 90 across 926 interventional studies indexed under Critical Illness.
Browse Critical Illness studies →Semmelweis University is the lead sponsor of 140 studies on the registry; 56 are open to participants now.
Compared within Critical Illness, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Professional Oral Care
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.
Behavioral: Standard Oral Care
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.
Behavioral: Standard Oral Care · Behavioral: ICU Staff Oral Care Education
Total edentulous patients included in a separate non-randomized cohort. These patients received standard oral care according to local ICU practice.
Behavioral: Standard Oral Care
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 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.
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.
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.
Time frame: Baseline and three times weekly during the ICU stay, through ICU discharge, an average of 30 days.
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.
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)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Up to 103 days after ICU admission.
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2023 to primary completion in Mar 2025, 20 months.
Of 400 non-industry interventional studies with no phase under Critical Illness, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 40. This study's 20 months is close to that.
Counting every sponsor, half of 404 studies reached it within 21 months; a quarter within 12 and three quarters within 40.
Critical Illness covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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