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

NCT07365956 | Completed DMC

• 1 other identifier: HarranU-MTAMER-001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oral Care

Keywords

Chlorhexidine Gluconate; Neurosurgery; Sodium Bicarbonate; nursing; apple cider vinegar

Outcome Measures

Primary Outcomes (1)

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

  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.

  Day 0 to Day 5

Study Arms (3)

Chlorhexidine Gluconate Group

EXPERIMENTAL

Before Oral Care: The Patient Identification Form was filled out. The Oral Assessment Scale was applied. An oral culture sample was obtained. Procedure: Participants receive oral care using chlorhexidine gluconate solution every 6 hours for 5 days in the neurosurgical intensive care unit.. The Oral Assessment Scale was applied. On the final day (Day 5), an oral culture sample was obtained.

Drug: Chlorhexidine gluconate (CHG)

Sodium Bicarbonate Group

EXPERIMENTAL

Before Oral Care: The Patient Identification Form was filled out. The Oral Assessment Scale was applied. An oral culture sample was obtained. Procedure: Participants receive oral care using sodium bicarbonate solution every 6 hours for 5 days in the neurosurgical intensive care unit. The Oral Assessment Scale was applied. On the final day (Day 5), an oral culture sample was obtained.

Drug: Sodium Bicarbonate (NaHCO3)

Apple Cider Vinegar Group

EXPERIMENTAL

Before Oral Care: The Patient Identification Form was filled out. The Oral Assessment Scale was applied. An oral culture sample was obtained. Procedure: Participants receive oral care using apple cider vinegar solution every 6 hours for 5 days in the neurosurgical intensive care unit. The Oral Assessment Scale was applied. On the final day (Day 5), an oral culture sample was obtained.

Other: Apple Cider Vinegar

Interventions

Sodium Bicarbonate (NaHCO3) DRUG

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

Sodium Bicarbonate Group

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.

Apple Cider Vinegar Group

Chlorhexidine gluconate (CHG) DRUG

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

Also known as: CHG

Chlorhexidine Gluconate Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Harran University: lead

Study Sites (1)

Inonu University

Malatya, 44050, Turkey (Türkiye)

Location

MeSH Terms

Interventions

chlorhexidine gluconate; Sodium Bicarbonate

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds

Study Officials

• Murat Tamer, Asst. Prof.

  Harran University

  STUDY DIRECTOR

• Meral Ozkan, Professor

  Inonu University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The patients in the experimental and control groups were determined using the Research Randomizer program (https://www.randomizer.org/). Before randomization, a drawing method was used to assign group numbers to the patients, designating 1 as the apple cider vinegar group, 2 as the chlorhexidine gluconate group, and 3 as the sodium bicarbonate group. Subsequently, numbers from 1 to 90 were randomized, and the groups were listed in order next to the numbers.

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 26, 2026
• Study Start: January 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)