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

Not Applicable

Recruiting

• Conditions: Oral Complication

• Registration Number: NCT07200297
• Lead Sponsor: SÜMEYYE BİLGİLİ TEKİN

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-10
• Study Start: 2025-09-15
• Study First Submitted QC: 2025-09-29
• Last Update Submitted: 2025-09-29
• Study First Posted: 2025-10-01
• Last Update Posted: 2025-10-01
• Primary Completion: 2026-01-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Saliva pH Value	From day 1 to day 3 (3 consecutive days).	Saliva pH Value: During the oral health assessment, pH will be measured with an indicator strip.; Unit of Measurement: pH units (0-14). Neutral pH (≈7) indicates a healthy oral environment. Saliva Production (Salivation): Salivation will be assessed using the Schirmer Tear Test Strip. The strip's wetted length will be recorded.; Unit of Measurement: Strip wetted in millimeters (mm). Longer wetted length indicates greater saliva production.

Trial Locations

Locations (1)

Ataturk University; Erzurum, Merkez, Turkey (Türkiye)