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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07200297
Enrollment
60
Registered
2025-10-01
Start date
2025-09-15
Completion date
2026-04-01
Last updated
2025-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Complication

Keywords

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

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.

Interventions

Patients who were given only a standard chlorhexidine oral care set

OTHERExperimental: Electric Toothbrush

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

OTHERExperimental: Manual Toothbrush

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

Sponsors

Ataturk University
CollaboratorOTHER
SÜMEYYE BİLGİLİ TEKİN
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Oral Health StatusFrom 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

MeasureTime frameDescription
Saliva pH ValueFrom 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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactSümeyye BİLGİLİ TEKİN
smeyyebilgili@gmail.com0506 175 93 71
Backup ContactBAHAR DOÇ.DR

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026