Effects of Three Oral Hygiene Protocols on Oral Bacteria in Intensive Care Patients

NCT07868549 | Enrolling By Invitation

• 1 other identifier: 05-PA-15-5/2017
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

Patients in intensive care may develop changes in the bacteria found in their mouths. Some of these bacteria can cause infections, and patients who cannot clean their own teeth depend on staff to provide oral care. This study compares three oral hygiene protocols to assess their effects on potentially harmful bacteria in the mouths of intensive care patients. All three protocols include cleaning the mouth with a toothbrush or sponge and fluoride toothpaste. One protocol uses this cleaning alone, one adds chlorhexidine, and one adds hexetidine. Chlorhexidine and hexetidine are antiseptics used to reduce microorganisms in the mouth. Trained nursing staff provide oral care twice daily. Saliva samples are collected before the first study oral care procedure, within 24 hours of intensive care admission, and again on the third day. The samples are examined to identify and count selected bacteria and yeasts. Bacteria are also tested for resistance to antibiotics. The study also examines whether antibiotic use, previous hospital stays, the type of breathing support, and oral hygiene at admission are associated with the presence of these microorganisms. The findings may help improve oral care protocols for intensive care patients.

Conditions

Oral Bacterial Colonization; Oral Hygiene

Keywords

Intensive Care Unit; Oral Care; Oral Hygiene Protocols; Gram-Negative Bacteria; Oral Microbiota; Salivary Microbiology; Chlorhexidine; Hexetidine; Toothbrushing; Antimicrobial Resistance; Candida; Critical Illness

Outcome Measures

Primary Outcomes (1)

• Change in Salivary Gram-Negative Bacterial Counts From Baseline to Day 3

  Change in the concentration of culturable Gram-negative bacteria in unstimulated saliva from baseline to day 3, compared among the three oral hygiene groups. Bacterial counts are expressed as colony-forming units per milliliter (CFU/mL), determined by quantitative culture on MacConkey agar. Assessed organisms include Klebsiella pneumoniae, Escherichia coli, Citrobacter species, Proteus species, Enterobacter species, Serratia species, Acinetobacter baumannii complex, and Pseudomonas aeruginosa. Baseline saliva is collected within 24 hours of intensive care admission, before the first study oral hygiene procedure. The day 3 sample is collected before oral hygiene.

  Baseline (within 24 hours of intensive care admission) and day 3

Study Arms (3)

Mechanical Oral Hygiene Alone

ACTIVE COMPARATOR

Participants receive oral cleaning with a suction toothbrush or sponge, according to their dentition, and fluoride toothpaste without sodium lauryl sulfate. Trained nursing staff perform oral care twice daily for three minutes. No additional antiseptic is used.

Procedure: Mechanical Oral Hygiene

Mechanical Oral Hygiene With Chlorhexidine

EXPERIMENTAL

Participants receive oral cleaning with a suction toothbrush or sponge, according to their dentition, and fluoride toothpaste without sodium lauryl sulfate, followed by application of 0.2% chlorhexidine using sterile gauze and a spatula. Trained nursing staff perform oral care twice daily for three minutes.

Procedure: Mechanical Oral Hygiene; Drug: Chlorhexidine

Mechanical Oral Hygiene With Hexetidine

EXPERIMENTAL

Participants receive oral cleaning with a suction toothbrush or sponge, according to their dentition, and fluoride toothpaste without sodium lauryl sulfate, followed by application of hexetidine using sterile gauze and a spatula. Trained nursing staff perform oral care twice daily for three minutes.

Procedure: Mechanical Oral Hygiene; Drug: Hexetidine

Interventions

Mechanical Oral Hygiene PROCEDURE

Oral cleaning with a suction toothbrush or sponge, according to the participant's dentition, and fluoride toothpaste without sodium lauryl sulfate. Oral care is performed by trained nursing staff twice daily for three minutes.

Mechanical Oral Hygiene Alone; Mechanical Oral Hygiene With Chlorhexidine; Mechanical Oral Hygiene With Hexetidine

Chlorhexidine DRUG

Application of 0.2% chlorhexidine to the oral cavity using sterile gauze and a spatula after mechanical cleaning, twice daily.

Mechanical Oral Hygiene With Chlorhexidine

Hexetidine DRUG

Application of hexetidine to the oral cavity using sterile gauze and a spatula after mechanical cleaning, twice daily.

Mechanical Oral Hygiene With Hexetidine

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Admission to the medical intensive care unit of Sestre milosrdnice University Hospital Center, Zagreb, Croatia, for pneumonia, exacerbation of chronic obstructive pulmonary disease, pulmonary embolism, or cardiac decompensation.
• Expected survival longer than 72 hours.
• Written informed consent provided by the patient or an authorized representative.
• Patients of either sex are eligible, regardless of age. Patients receiving or not receiving antibiotic therapy may participate. Patients breathing spontaneously or receiving noninvasive or invasive mechanical ventilation are eligible.

You may not qualify if:

• Allergy to chlorhexidine or hexetidine.
• Treatment with immunosuppressive agents or corticosteroids.
• Previous radiotherapy to the head and neck region.
• Presence of oral mucosal lesions at the baseline examination.

Sponsors & Collaborators

• University of Zagreb: lead

Study Sites (1)

University of Zagreb School of Dental Medicine

Zagreb, 10000, Croatia

Location

Related Publications (3)

• Aoun G, Saadeh M, Berberi A. Effectiveness of Hexetidine 0.1% Compared to Chlorhexidine Digluconate 0.12% in Eliminating Candida Albicans Colonizing Dentures: A Randomized Clinical In Vivo Study. J Int Oral Health. 2015 Aug;7(8):5-8.

  PMID: 26464531 BACKGROUND

• Alhazzani W, Smith O, Muscedere J, Medd J, Cook D. Toothbrushing for critically ill mechanically ventilated patients: a systematic review and meta-analysis of randomized trials evaluating ventilator-associated pneumonia. Crit Care Med. 2013 Feb;41(2):646-55. doi: 10.1097/CCM.0b013e3182742d45.

  PMID: 23263588 BACKGROUND

• Hua F, Xie H, Worthington HV, Furness S, Zhang Q, Li C. Oral hygiene care for critically ill patients to prevent ventilator-associated pneumonia. Cochrane Database Syst Rev. 2016 Oct 25;10(10):CD008367. doi: 10.1002/14651858.CD008367.pub3.

  PMID: 27778318 BACKGROUND

MeSH Terms

Conditions

Torulopsis; Critical Illness

Interventions

Chlorhexidine; Hexetidine

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Laboratory personnel assessing the microbiological outcomes were masked to the assigned oral hygiene protocol.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DMD

Model Details: This single-center study uses a parallel-group design with three oral hygiene protocols. Participants are assigned consecutively according to a predefined repeating sequence (Protocol 1, Protocol 2, Protocol 3). Each participant receives the assigned protocol throughout the study. The protocols comprise mechanical cleaning with fluoride toothpaste alone, the same cleaning with chlorhexidine, or the same cleaning with hexetidine.

Study Record Dates

• First Submitted: October 5, 2026
• First Posted: October 9, 2026
• Study Start: June 1, 2026
• Primary Completion: September 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)