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NCT Number: NCT07200297

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

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.

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Key information

Conditions

Oral Complication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ataturk University

Erzurum, Merkez, 25240, Turkey (Türkiye)

Location status: Recruiting

Location contact

GAMZE KOÇ

CONTACT

0533 026 33 09

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Active Comparator: Control

Other

Patients who were given only a standard chlorhexidine oral care set

Experimental: Electric Toothbrush

Other

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

Experimental: Manual Toothbrush

Other

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

Primary outcomes

  1. Oral Health Status

    Time frame: 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 outcomes

  1. Saliva pH Value

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

BAHAR DOÇ.DR

CONTACT

Sümeyye BİLGİLİ TEKİN

CONTACT

[email protected]

0506 175 93 71

Sponsors and collaborators

Lead sponsor

SÜMEYYE BİLGİLİ TEKİN

Other

Collaborators

  • Ataturk University

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 1, 2025
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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