Oral ComplicationNCT07200297
A Comparative Study of Three Oral Care Methods in NIMV Patients in Intensive Care
A study testing Experimental: Electric Toothbrush and Experimental: Manual Toothbrush in people with Oral Complication, run by SÜMEYYE BİLGİLİ TEKİN at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Complication
- What is being tested?
- Experimental: Electric Toothbrush and Experimental: Manual Toothbrush
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2025to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
BAHAR DOÇ.DR contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ataturk University
Erzurum, Merkez, 25240
GAMZE KOÇ, 0533 026 33 09
About this study
Official 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
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
- Being tested
- Active Comparator: Control, Experimental: Electric Toothbrush, Experimental: Manual Toothbrush
- Keywords
- Toothbrushing, Intensive Care Units, Non-invasive Ventilation, Oral care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Comparator: ControlOther
Patients who were given only a standard chlorhexidine oral care set
Experimental: Electric ToothbrushOther
Patients who were given an electric toothbrush and toothpaste along with a chlorhexidine set
Experimental: Manual ToothbrushOther
Patients who were given a manual toothbrush and toothpaste along with a chlorhexidine set.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Not described Receives: Other: Active Comparator: Control |
| Electric Toothbrush | Experimental | Not described Receives: Other: Experimental: Electric Toothbrush |
| Manual Toothbrush | Experimental | Not described Receives: Other: Experimental: Manual Toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From day 1 to day 3 (3 consecutive days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start15 Sep 2025
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SÜMEYYE BİLGİLİ TEKİN
- Sponsor type
- University, hospital or other
- Collaborators
- Ataturk University
- Responsible party
- Sponsor-investigator, SÜMEYYE BİLGİLİ TEKİN, Ataturk University
- Investigators
- Reva PROF.DR, Principal investigator, https://avesis.atauni.edu.tr/reva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07200297
- Sponsor's protocol ID
- AU-SBİLGİLİ_003
- Status last verified
- Sep 2025
- First submitted
- 10 Sep 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07200297
- Acronym / sponsor ID
- AU-SBİLGİLİ_003
- Conditions
- Oral Complication
- Keywords
- Toothbrushing, Intensive Care Units, Non-invasive Ventilation, Oral care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- SÜMEYYE BİLGİLİ TEKİNUniversity, hospital or other
- Collaborators
- Ataturk University
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Active Comparator: Control |
| Electric Toothbrush | Experimental | Other: Experimental: Electric Toothbrush |
| Manual Toothbrush | Experimental | Other: Experimental: Manual Toothbrush |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Comparator: ControlPatients who were given only a standard chlorhexidine oral care set | Other | Control |
| Experimental: Electric ToothbrushPatients who were given an electric toothbrush and toothpaste along with a chlorhexidine set | Other | Electric Toothbrush |
| Experimental: Manual ToothbrushPatients who were given a manual toothbrush and toothpaste along with a chlorhexidine set. | Other | Manual Toothbrush |
Primary outcome
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.
1 secondary outcome
Saliva pH Value
Time frame: From day 1 to day 3 (3 consecutive days).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
BAHAR DOÇ.DR contact
Reva PROF.DR principal investigator
https://avesis.atauni.edu.tr/reva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Electric Toothbrush and Experimental: Manual Toothbrush in people with Oral Complication, run by SÜMEYYE BİLGİLİ TEKİN at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sümeyye BİLGİLİ TEKİN (0506 175 93 71, smeyyebilgili@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral Health Status (time frame: From day 1 to day 3 (3 consecutive days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.