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Completed

NCT Number: NCT07831564

Professional Oral Care and Staff Education in Critically Ill Patients

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.

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Key information

Conditions

Critically Ill Critical Illness Cross Infection Disease Attributes Gingival Diseases Gingivitis Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Mouth Diseases Oral Care Performance Oral Health Care Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Pneumonia Pneumonia, Ventilator-Associated Respiratory Tract Diseases Respiratory Tract Infections Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bajcsy-Zsilinszky Hospital, Budapest, Hungary

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Professional Oral Care

Behavioral

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

Behavioral

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 Education

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    Gingival inflammation was assessed clinically at each oral examination. Gingivitis prevalence was compared between study groups and across repeated examinations during the ICU stay.

  2. Incidence of ventilator-associated pneumonia (VAP)

    Time frame: Through ICU discharge, an average of 30 days.

    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.

  3. Duration of mechanical ventilation

    Time frame: From initiation of invasive mechanical ventilation until discontinuation or death, whichever occurred first, assessed up to 43 days.

    Duration of invasive mechanical ventilation, measured in days from initiation of mechanical ventilation until discontinuation or death, whichever occurred first.

  4. ICU length of stay

    Time frame: From ICU admission until ICU discharge or death, whichever occurred first, assessed up to 66 days.

    Duration of the intensive care unit stay, measured in days from ICU admission until ICU discharge or death, whichever occurred first.

  5. Hospital length of stay

    Time frame: From hospital admission until hospital discharge or death, whichever occurred first, assessed up to 103 days.

    Duration of hospital stay, measured in days from hospital admission until hospital discharge or death, whichever occurred first.

  6. All-cause mortality

    Time frame: Up to 103 days after ICU admission.

    All-cause mortality during hospitalization, recorded as a dichotomous outcome (yes/no).

Sponsors and collaborators

Lead sponsor

Semmelweis University

Other

Registry information

Official study title

Professional Oral Care and Staff Education to Improve Oral Hygiene in Critically Ill Patients: A Prospective Controlled Clinical Study

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 21, 2026
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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