The Effect of an Suction Toothbrush on the Development of Ventilator-Associated Pneumonia

NCT07125495 | Completed DMC

• 1 other identifier: ToothbrushICU
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

Literature suggests that suction toothbrushes may improve oral care in intubated patients by facilitating secretion removal and reducing microaspiration. This could decrease the need for endotracheal suctioning and lower the risk of ventilator-associated pneumonia (VAP). Therefore, this study aimed to examine the effect of a suction toothbrush on the development of VAP in intubated patients.

Conditions

Infection; Intensive Care (ICU); Intubation; Intubation Complication

Keywords

oral care; tootbrush; intensive care; intubation; Ventilatory-associated pneumonia

Outcome Measures

Primary Outcomes (1)

• The ventilatory associated pneumonia (VAP)

  The development of ventilator-associated pneumonia (VAP) after entubation in the intensive care unit (Yes / no). If a patient presents signs and symptoms of VAP with both clinical Findings and laboratory findings, researchers will diagnose it as a VAP.

  Patients were included 48 hours after admission to the intensive care unit and intubation. After 48 hours of intubation, the development of VAP will be considered as a positive.

Study Arms (3)

Suction tootbrush + distilled water

EXPERIMENTAL

All tooth surfaces, oral mucosa, and the tongue and surrounding area were cleaned every 8 hours (3x1) with distilled water and a suction toothbrush. The aspiration feature of the suction toothbrush enabled oral care and simultaneous aspiration of oropharyngeal secretions.

Other: Suction tootbrush and distiled water

Suction toothbrush + 0.12% chlorhexidine gluconate oral solution

ACTIVE COMPARATOR

Every 8 hours (3x1) 15 ml of 0.12% chlorhexidine gluconate oral solution (Adıgüzel, 2015) will be used with a suction toothbrush to clean all tooth surfaces, the oral mucosa, and the tongue. The aspiration feature of the suction toothbrush allows for the aspiration of oropharyngeal secretions during oral care.

Other: suction tootbrush and .12% chlorhexidine gluconate

oral care sponge + 0.12% chlorhexidine gluconate oral solution

ACTIVE COMPARATOR

All tooth surfaces, oral mucosa, and the tongue and surrounding tongue were cleaned with 15 ml of 0.12% chlorhexidine gluconate oral solution (Adıgüzel, 2015) every 8 hours (3x1) with an oral care sponge used in oral care.

Other: Oral care sponge and with 15 ml of 0.12% chlorhexidine gluconate oral solution

Interventions

Suction tootbrush and distiled water OTHER

All tooth surfaces, oral mucosa, and the tongue and surrounding area were cleaned every 8 hours (3x1) with distilled water and a suction toothbrush. The aspiration feature of the suction toothbrush enabled oral care and simultaneous aspiration of oropharyngeal secretions.

Suction tootbrush + distilled water

suction tootbrush and .12% chlorhexidine gluconate OTHER

Every 8 hours (3x1) 15 ml of 0.12% chlorhexidine gluconate oral solution (Adıgüzel, 2015) will be used with a suction toothbrush to clean all tooth surfaces, the oral mucosa, and the tongue. The aspiration feature of the suction toothbrush allows for the aspiration of oropharyngeal secretions during oral care.

Suction toothbrush + 0.12% chlorhexidine gluconate oral solution

Oral care sponge and with 15 ml of 0.12% chlorhexidine gluconate oral solution OTHER

All tooth surfaces, oral mucosa, and the tongue and surrounding tongue were cleaned with 15 ml of 0.12% chlorhexidine gluconate oral solution (Adıgüzel, 2015) every 8 hours (3x1) and an oral care sponge used in oral care in the intensive care unit. After oral care, oropharyngeal secretions were aspirated.

oral care sponge + 0.12% chlorhexidine gluconate oral solution

Eligibility Criteria

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

You may qualify if:

• Patients
• who aged over 18 years
• who underwent orotracheal intubation after admission to the ICU,
• who had no known pneumonia or diagnosis of pneumonia at the time of intubation,
• who were intubated for more than 48 hours,
• who had no microorganisms detected in the tracheal aspirate within the first 48 hours,
• who had no lesions on the oral mucous membrane before intubation,
• who had no known allergy to chlorhexidine were included in the study.

You may not qualify if:

• Patients
• who under 18 years of age,
• those with a tracheostomy,
• those were intubated for less than 48 hours,
• those with microorganisms detected in their tracheal aspirate within the first 48 hours,
• those who underwent reintubation,
• those were pregnant,
• those with lesions in the oral mucosa during intensive care admission,
• those with bleeding coagulation disorders or thrombocytopenia,
• those admitted to intensive care from an external institution while intubated, and those with a known chlorhexidine allergy were excluded from the study.

Sponsors & Collaborators

• Koç University: lead
• Koç University Hospital: collaborator

Study Sites (1)

Koç University hospital Intensive care unit

Istanbul, 34010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Infections

Interventions

chlorhexidine gluconate

Study Officials

• Zeliha Genç, PhD

  Koç University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 15, 2025
• Study Start: February 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: September 20, 2025
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)