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

NCT07200297 | Recruiting

• 1 other identifier: AU-SBİLGİLİ_003
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Complication

Keywords

Toothbrushing; Intensive Care Units; Non-invasive Ventilation; Oral care

Outcome Measures

Primary Outcomes (1)

• Oral Health Status

  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.

  From day 1 to day 3 (3 consecutive days).

Secondary Outcomes (1)

• Saliva pH Value

  From day 1 to day 3 (3 consecutive days).

Study Arms (3)

Control

ACTIVE COMPARATOR

Other: Active Comparator: Control

Electric Toothbrush

EXPERIMENTAL

Other: Experimental: Electric Toothbrush

Manual Toothbrush

EXPERIMENTAL

Other: Experimental: Manual Toothbrush

Interventions

Active Comparator: Control OTHER

Patients who were given only a standard chlorhexidine oral care set

Control

Experimental: Electric Toothbrush OTHER

Patients who were given an electric toothbrush and toothpaste along with a chlorhexidine set

Electric Toothbrush

Experimental: Manual Toothbrush OTHER

Patients who were given a manual toothbrush and toothpaste along with a chlorhexidine set.

Manual Toothbrush

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SÜMEYYE BİLGİLİ TEKİN: lead
• Ataturk University: collaborator

Study Sites (1)

Ataturk University

Erzurum, Merkez, 25240, Turkey (Türkiye)

RECRUITING

Study Officials

• Reva PROF.DR

  https://avesis.atauni.edu.tr/reva

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sümeyye BİLGİLİ TEKİN

CONTACT

0506 175 93 71; smeyyebilgili@gmail.com

BAHAR DOÇ.DR

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Nursing Fundamentals Graduate Student

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: October 1, 2025
• Study Start: September 15, 2025
• Primary Completion: January 1, 2026
• Study Completion: April 1, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)