A Comparative Study of Three Oral Care Methods in NIMV Patients in Intensive Care

SÜMEYYE BİLGİLİ TEKİN

Status: Enrolling

Conditions: Oral Complication

Treatments: Other: Experimental: Electric Toothbrush; Other: Experimental: Manual Toothbrush; Other: Active Comparator: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT07200297

AU-SBİLGİLİ_003

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Control

Active Comparator group

Treatment:

Other: Active Comparator: Control

Electric Toothbrush

Experimental group

Treatment:

Other: Experimental: Electric Toothbrush

Manual Toothbrush

Experimental group

Treatment:

Other: Experimental: Manual Toothbrush