Professional Oral Care and Staff Education in Critically Ill Patients

NCT07831564 | Completed

• 1 other identifier: 97-2023
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Critically Ill; Critical Illness; Oral Care Performance; Oral Health Care

Keywords

oral hygiene; oral care; critical illness; intensive care; orotracheal intubation; gingivitis; ventilator-associated pneumonia; staff education

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Baseline and three times weekly during the ICU stay, through ICU discharge, an average of 30 days.

• Incidence of ventilator-associated pneumonia (VAP)

  Through ICU discharge, an average of 30 days.

• Duration of mechanical ventilation

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

• ICU length of stay

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

• Hospital length of stay

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

Study Arms (4)

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.

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.

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.

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.

Behavioral: Standard Oral Care

Interventions

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.

Professional Oral Care

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.

Standard oral care; Total edentulous; Upskill

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.

Upskill

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Semmelweis University: lead

Study Sites (2)

Dr. Manninger Jenő National Trauma Center

Budapest, 1081, Hungary

Location

Bajcsy-Zsilinszky Hospital

Budapest, 1106, Hungary

Location

MeSH Terms

Conditions

Critical Illness; Gingivitis; Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Healthcare-Associated Pneumonia; Cross Infection; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease

Study Officials

• Szandra K Körmendi, PhD, DMD

  Semmelweis University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: September 21, 2026
• Study Start: June 15, 2023
• Primary Completion: March 14, 2025
• Study Completion: September 9, 2025
• Last Updated: September 21, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

HU (2)