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NCT Number: NCT07365956

Comparison of Oral Care Solutions on Oral Microbial Colonization in Neurosurgical ICU Patients

In the high-stakes environment of the Neurosurgery Intensive Care Unit (NSICU), patient stability extends beyond neurological monitors and intracranial pressure readings. A critical yet often underemphasized front line of defense is oral health. Neurosurgery patients, frequently intubated, on mechanical ventilation, or with depressed consciousness, are at extreme risk for Ventilator-Associated Pneumonia (VAP) and systemic infections. Pathogenic oral microbiota can be aspirated into the lower respiratory tract, triggering such complications. Consequently, rigorous oral care is not merely a comfort measure but a vital infection control protocol. This article examines and compares the effects of three agents-Chlorhexidine Gluconate (CHG), Sodium Bicarbonate, and Apple Cider Vinegar (ACV)-on oral microbial colonization in this vulnerable population.

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Key information

Conditions

Oral Care

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inonu University

Malatya, 44050, Turkey (Türkiye)

About this study

The normal oral flora undergoes a dramatic shift in critically ill patients. Factors like mouth breathing, nil-by-mouth status, decreased salivary flow, and the presence of endotracheal tubes create a pathogenic-friendly environment. This dysbiosis leads to colonization by opportunistic pathogens like Staphylococcus aureus, Pseudomonas aeruginosa, and Candida species. For neurosurgery patients, an ensuing pneumonia can lead to sepsis, increased intracranial pressure from systemic inflammation, prolonged ventilation, and longer ICU stays, directly impacting neurological recovery.

Aim of this study to examine the effect of oral care using ACV, chlorhexidine gluconate and sodium bicarbonate on oral microbial colonization in neurosurgery intensive care patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Mechanical ventilation was initiated less than 24 hours ago,
  • Aged 18 years or older,
  • Had not undergone any oral surgical procedure,
  • Were not leukopenic or thrombocytopenic,
  • And had no oral infection such as aphthous ulcer, stomatitis, or gingivitis.

Exclusion criteria

  • Mechanical ventilation was initiated more than 24 hours ago,
  • Under 18 years of age,
  • Had undergone any oral surgical procedure,
  • Were leukopenic or thrombocytopenic,
  • Or had an oral infection such as aphthous ulcer, stomatitis, or gingivitis.

Treatment and study plan

Chlorhexidine gluconate (CHG)

Drug

Oral care performed using chlorhexidine gluconate solution as part of routine oral hygiene in neurosurgical intensive care unit patients.

Other names: CHG

Sodium Bicarbonate (NaHCO3)

Drug

Oral care performed using sodium bicarbonate solution to reduce oral microbial colonization in neurosurgical intensive care unit patients.

Apple Cider Vinegar

Other

Oral care performed using diluted apple cider vinegar solution as an alternative oral hygiene intervention in neurosurgical intensive care unit patients.

Primary outcomes

  1. Change From Baseline in Oral Microbial Colonization Levels and Oral Assessment Scale Score

    Time frame: Day 0 to Day 5

    Oral microbial colonization will be measured using quantitative culture analysis of oral swab samples. Results will be reported as colony-forming units (CFU). The primary outcome is the change in CFU values from baseline (Day 0) to Day 5 following the oral care intervention.

    Oral mucosal condition will be measured using the Oral Assessment Scale. Scores will be recorded at baseline (Day 0) and on Day 5. The outcome will be reported as the change in total scale score between the two time points.

    All outcome measurements were completed within the first 5 days following initiation of the oral care intervention.

Sponsors and collaborators

Lead sponsor

Harran University

Other

Registry information

Official study title

The Effect of Oral Care Using Apple Cider Vinegar, Chlorhexidine Gluconate and Sodium Bicarbonate on Oral Microbial Colonization in Neurosurgery Intensive Care Patients

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 26, 2026
Registry last updated
Jan 26, 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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