- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07365956
Comparison of Oral Care Solutions on Oral Microbial Colonization in Neurosurgical ICU Patients
The Effect of Oral Care Using Apple Cider Vinegar, Chlorhexidine Gluconate and Sodium Bicarbonate on Oral Microbial Colonization in Neurosurgery Intensive Care Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Malatya, Turkey (Türkiye), 44050
- İnonu University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Chlorhexidine Gluconate Group
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. |
Oral care performed using chlorhexidine gluconate solution as part of routine oral hygiene in neurosurgical intensive care unit patients.
Other Names:
|
|
Experimental: Sodium Bicarbonate Group
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.
|
Oral care performed using sodium bicarbonate solution to reduce oral microbial colonization in neurosurgical intensive care unit patients.
|
|
Experimental: Apple Cider Vinegar Group
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.
|
Oral care performed using diluted apple cider vinegar solution as an alternative oral hygiene intervention in neurosurgical intensive care unit patients.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
Day 0 to Day 5
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Murat Tamer, Asst. Prof., Harran University
- Principal Investigator: Meral Ozkan, Professor, İnonu University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HarranU-MTAMER-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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