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

NCT07200297 · tracked via the Priya Life Science Turkey tracker

Sponsor

SÜMEYYE BİLGİLİ TEKİN

Phase

Not applicable

Started

2025-09-15

Last updated

2025-10-01

Condition(s) studied

Oral Complication

Investigational drug(s) / intervention(s)

Active Comparator: ControlExperimental: Electric ToothbrushExperimental: Manual Toothbrush

Active Comparator: Control: Patients who were given only a standard chlorhexidine oral care set

Experimental: Electric Toothbrush: Patients who were given an electric toothbrush and toothpaste along with a chlorhexidine set

Experimental: Manual Toothbrush: Patients who were given a manual toothbrush and toothpaste along with a chlorhexidine set.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

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.

Primary outcome measure(s)

Oral Health Status — From day 1 to day 3 (3 consecutive days).
Oral health will be assessed using the Oral Assessment Guide (OAG). The guide examines eight areas (voice, swallowing, lips, tongue, saliva, mucous membranes, gums, and teeth/dentures). Each item is scored from 1 (healthy) to 3 (severely impaired). The total score ranges from 8-24. Scale score (8-24). A low score indicates good oral health, while a high score indicates deterioration in oral health.

Trial sites (1)

Facility	City	Region	Status
Ataturk University	Erzurum	Merkez	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07200297 on ClinicalTrials.gov ↗ ← All trials in Turkey