A Comparative Study of Three Oral Care Methods in NIMV Patients in Intensive Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Active Comparator: Control, Experimental: Electric Toothbrush, Experimental: Manual Toothbrush.
- Who it may be relevant to
- Registry conditions: Oral Complication. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Three Different Oral Care Methods in Terms of Oral Health in Intensive Care Patients Receiving Non-Invasive Mechanical Ventilation: A Randomized Controlled Trial
Overview
This study aims to examine the effects of different oral care methods on oral health in patients receiving non-invasive mechanical ventilation (NIMV) in the intensive care unit. A randomized controlled experimental design will be employed, with three groups: Control Group - patients receiving only the standard chlorhexidine oral care kit; Electric Toothbrush Group - patients receiving the chlorhexidine kit in combination with an electric toothbrush and toothpaste; and Manual Toothbrush Group - patients receiving the chlorhexidine kit along with a manual toothbrush and toothpaste. Data collection tools will include the Patient Demographic Information Form, Oral Assessment Guide, saliva pH measurement, and salivation assessment using the Schirmer Tear Test Strip. The study is designed to compare the effects of different oral care methods on the oral health of patients receiving NIMV and to identify the most effective method.
Interventions
- Other Active Comparator: Control
Patients who were given only a standard chlorhexidine oral care set - Other Experimental: Electric Toothbrush
Patients who were given an electric toothbrush and toothpaste along with a chlorhexidine set - Other Experimental: Manual Toothbrush
Patients who were given a manual toothbrush and toothpaste along with a chlorhexidine set.
Primary outcome measures
- Oral Health Status [Time frame: From day 1 to day 3 (3 consecutive days).]
Secondary outcome measures (1)
- Saliva pH Value [Time frame: From day 1 to day 3 (3 consecutive days).]
Eligibility criteria
Inclusion criteria
- Must be in an intensive care unit
- Must have consented to participate in the study from themselves or their family
- Must be over 18 years of age
- Must be on a non-invasive mechanical ventilator
- Must have no known active infection.
- Must be in a stable state of consciousness and able to communicate.
- Must be expected to remain in intensive care for at least 48 hours.
Exclusion criteria
- Intubated patients.
- Patients with severe oral infections or bleeding mucosal wounds.
- Those receiving radiotherapy/chemotherapy to the head and neck region.
- Organ transplant patients.
- Patients without oral anatomic abnormalities or dentures.
- Those who refused to participate in the study or did not sign the consent form.
- Patients with chronic or acute health conditions that prevent oral hygiene.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Turkey (Türkiye) · 1 center
- Ataturk University — Erzurum
Identifiers
NCT: NCT07200297 · AU-SBİLGİLİ_003