A Comparative Study of Three Oral Care Methods in NIMV Patients in Intensive Care
ConditionOral Complication
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSÜMEYYE BİLGİLİ TEKİN
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Intubated patients.
Patients with severe oral infections or bleeding mucosal wounds.
Those receiving radiotherapy/chemotherapy to the head and neck region.
Organ transplant patients.
Trial design
Design model
Parallel
Treatments tested in this trial
Active Comparator: Control
Other interventionPatients who were given only a standard chlorhexidine oral care set
Experimental: Electric Toothbrush
Other interventionPatients who were given an electric toothbrush and toothpaste along with a chlorhexidine set
Experimental: Manual Toothbrush
Other interventionPatients who were given a manual toothbrush and toothpaste along with a chlorhexidine set.
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: ControlActive comparator 1 intervention
Group B: Electric ToothbrushExperimental treatment 1 intervention
Group C: Manual ToothbrushExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
From day 1 to day 3 (3 consecutive days).Secondary outcomes
1
Saliva pH Value
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.
Time frame
From day 1 to day 3 (3 consecutive days).Sponsors and contacts
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SÜMEYYE BİLGİLİ TEKİN
Lead sponsor
Ataturk University
Sponsor institution
Ataturk University
Collaborator
Source ClinicalTrials.gov