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Intensive CareOral CareNCT06709183

Oral Care Apparatus for Intubated Patients

A study of Intensive Care and Oral Care, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

There are several practical challenges in providing oral care to intubated patients. The presence of an endotracheal tube often makes it difficult to thoroughly evaluate the oral cavity, and there is a risk of tube displacement or removal during oral care. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Intensive Care, Oral Care, Intubated ICU Patients
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
32 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Dec 2025to 28 Feb 2026
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Volunteering to participate in the study,
  • Having at least 6 months of work experience in an intensive care unit (Sayın, 2020),
  • Working as a nurse in adult intensive care units.

Who cannot join

  • Working as a nurse in a neonatal intensive care unit.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Bitlis State Hospital

    Bitlis, Merkez, 13200

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Oral Care Retractor Developed for Intubated Patients in Intensive Care Unit on Oral Care Practices

There are several practical challenges in providing oral care to intubated patients. The presence of an endotracheal tube often makes it difficult to thoroughly evaluate the oral cavity, and there is a risk of tube displacement or removal during oral care. Additionally, the lack of standardized care protocols, limited time, and inadequate equipment further complicate the assessment of oral mucosal membranes, increase the likelihood of complications, and prolong ICU stays. The literature also highlights that intubated patients often exhibit behaviors such as gagging, biting the tube, or turning their head during oral care. These actions make it challenging for ICU nurses to use oral care tools effectively, resulting in insufficient evaluation and cleaning of the oral cavity. In a study conducted by Dale et al., ICU healthcare workers emphasized the need for an oral device that could withstand biting pressure, keep the teeth separated, and be flexible enough to prevent discomfort while enabling effective oral care. However, the literature does not report the existence of a device designed to open the oral cavity for intubated patients during oral care. Inspired by cheek retractors used in dentistry, this project aims to design an oral care retractor specifically for intubated patients. This device would facilitate the evaluation of the oral cavity and provide a clear view during oral care, enabling effective oral hygiene practices.

Read the detailed description

Intensive care units (ICUs) are facilities where basic and advanced life support are provided for patients who are completely bedridden, unable to perform daily living activities, and require constant nursing care. These patients often receive oxygen therapy or mechanical ventilation. Most ICU patients are dependent on nursing care, placing significant responsibilities on ICU nurses to meet self-care needs. One of these essential self-care interventions is oral care.

Oral care includes approaches such as assessing the oral cavity, maintaining saliva production, preventing the formation of microorganisms, reducing plaque and related diseases, and cleaning and moisturizing oral tissues. Effective oral care provides comfort and helps prevent infections. The absence of regular and effective oral care in ICU patients allows pathogens to proliferate in the oral cavity, increasing microbial load. Patients undergoing endotracheal intubation and mechanical ventilation are particularly at risk for developing systemic infections such as oral infections or healthcare-associated pneumonia. Endotracheal tubes can lead to debris accumulation, create an environment conducive to microbial growth, and keep the mouth continuously open, resulting in xerostomia, dental plaque buildup, and reduced saliva production. Oral care reduces bacterial colonization in the oropharyngeal cavity and prevents adverse outcomes such as poor oral health and respiratory infections.

There are, however, practical challenges in providing oral care to intubated patients. These challenges include difficulty in thoroughly assessing the oral cavity due to the presence of the endotracheal tube, the risk of tube displacement or removal during oral care, the lack of standardized care protocols, and limited time and equipment. These factors complicate the evaluation of oral mucosal membranes, increase the likelihood of complications, and prolong hospital stays. Additionally, the literature notes that intubated patients often exhibit challenging behaviors during oral care, such as gagging, biting the tube, or turning their head, making it difficult for ICU nurses to use oral care tools effectively. This can result in insufficient evaluation and cleaning of the oral cavity. In a study by Dale et al., ICU healthcare workers expressed the need for an oral device that could resist biting pressure, keep the teeth separated, and be flexible enough to prevent discomfort while enabling effective oral care. Inspired by cheek retractors used in dentistry, we designed an oral care retractor to facilitate the evaluation of the oral cavity in intubated patients and enable clear visualization during oral care. This study aims to assess the impact of this newly developed oral care retractor on oral care practices in intubated patients in the ICU.

Being tested
Intervention-Control, Control - intervention
Keywords
intensive care, oral care, oral care retractor, intubated ICU patients

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intervention-ControlOther

    Also called Oral care retractor

    Nurses in this group will start the first oral care practice by using the oral care retractor on the model. Before starting the procedure, the nurses will fill in the 'Beck Mouth Assessment Guide' and after the procedure, they will fill in the 'Oral Care Practices Evaluation Form'. A rest period of at least 10 minutes will be provided before the second oral care application. Standard oral care will be applied during the second application. Similarly, nurses will complete the 'Beck Oral Assessment Guide' before the procedure and the 'Oral Care Practices Assessment Form' after the procedure. At the end of both procedures, nurses will complete the 'Quebec Assistive Technology User Satisfaction Assessment Questionnaire (Q-ATUSA)' and the 'Interview Form'. The 'Interview Form' will be used to collect nurses' experiences and opinions about the oral care procedure. During the interview, audio recordings will be made with the knowledge of the nurses.

  • Control - interventionOther

    Also called Standard oral care

    In the first oral care procedure, nurses in this group will perform standard oral care on the model without using the oral care retractor. They will complete the 'Beck Oral Assessment Guide' before the procedure and the 'Oral Care Practices Evaluation Form' after the procedure. There will be a rest period of at least 10 minutes before the second oral care procedure. During this procedure, the second group of nurses who initially perform standard oral care will perform oral care using an oral care retractor. Similarly, they will complete the 'Beck Oral Assessment Guide' before the procedure and the 'Oral Care Practices Evaluation Form' after the procedure. At the end of both procedures, nurses will complete the 'Quebec Assistive Technology User Satisfaction Assessment Questionnaire (Q-ATUSA)' and the 'Interview Form'. The 'Interview Form' will be used to obtain nurses' experiences and opinions regarding oral care practices..

Study groups in NCT06709183
Study groupRoleWhat they receive
Standard Oral Care (Control- Intervention)Sham comparatorThe nurses in the control-intervention group will perform standard oral care in the first oral care and oral care using the oral care retractor in the second oral care.
Receives: Other: Control - intervention
Oral Care Retractor (Intervention-control)Active comparatorThe nurses in the intervention-control group will perform the first oral care with an oral care retractor, and in the second oral care, they will perform standard oral care without using an oral care retractor.
Receives: Other: Intervention-Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Oral Cavity Assessment

    Beck Oral Cavity Assessment Guide: This scale was developed by Beck. It comprises five subscales: lips, gums, oral mucosa, tongue, teeth and saliva, each of which is scored on a four-point Likert scale. The total score for this tool ranges from 5 to 20. A low score indicates good oral health, whilst a high score indicates the presence of problems. Therefore, a score of 5-10 indicates mild functional impairment, 11-15 indicates moderate functional impairment, and 16-20 indicates severe functional impairment.

    Measured: It will be filled 2 minutes after the end of the application.

  2. Effect on Oral Care Applications

    Oral Care Practice Assessment Form: This form was developed by the researcher in line with the literature (Dagnew et al., 2020; Dale et al., 2018; Thapa and Shrestha, 2019) and consists of four questions regarding oral care practice, oral assessment, the ease of placing care materials into the mouth, and concerns about the endotracheal tube dislodging. The form was completed by the nurses participating in the study, who were asked to rate the oral care they performed on the simulator manikin on a Visual Analogue Scale (VAS) ranging from 0 to 10. VAS ratings were categorised as low (0-3), moderate (4-6) and high (7-10).

    Measured: It will be filled 2 minutes after the end of the application.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2024
  2. Study start1 Dec 2025
  3. Primary completion28 Dec 2025
  4. Study completion28 Feb 2026

Resources

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
Other
Allocation
Randomised
Intervention model
Crossover
Model description
The research will be conducted through simulation using a standard mannequin in room 428 in the general intensive care unit. Room 428 in the general intensive care unit is a standard intensive care room with four walls of glass, 15 m2 in size, one supply cabinet, one cloakroom, oxygen panel, mechanical ventilator, monitor and single bed, where patients can be monitored instantly with a camera system. In our study, this intensive care room will be used to evaluate the effectiveness of the oral care retractor designed for intensive care patients in order to ensure that oral care procedures to be applied by nurses are in a realistic environment and that nurses feel as if they are applying to a live patient. Simulation method will be used for the experimental study part of this research. Laerdal brand MegaCode Kelly emergency care simulator will be used in the study.
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06709183
Sponsor's protocol ID
2024Phd
Acronym
Oral Care
Status last verified
Oct 2026
First submitted
20 Nov 2024
Last updated
20 Oct 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bayrak-Kahraman, B., Özdemir, L. 2016. "Evaluation of behavioral and physiological pain indicators of intensive care patients during invasive interventions". Journal of Research and Development in Nursing, 18(3), 13-21.

  • Bayrak, S., Akın, S. 2022. "Investigation of intensive care nurses' knowledge and practices regarding oral care interventions applied to intubated patients". Hamidiye University of Health Sciences.

  • Kara, A., Bölükbaş, N. 2019. "Determination of pain behaviors in intubated intensive care patients with endotracheal tube and oral care". Ordu University.

  • Korhan, E. A., Yönt, G. H., Demiray, A., Akça, A., Eker, A. 2015. "Determination of nursing diagnoses in intensive care unit and evaluation according to Nanda diagnoses". 5(1), 16-21.

  • Özdemir, S. 2020. "The effect of different concentrations of chlorhexidine used in oral care of patients on mechanical ventilation support on microbial colonization". Aydın Adnan Menderes University.

  • Yakut E, Duger T, Oksuz C, Yorukan S, Ureten K, Turan D, Frat T, Kiraz S, Krd N, Kayhan H, Yakut Y, Guler C. Validation of the Turkish version of the Oswestry Disability Index for patients with low back pain. Spine (Phila Pa 1976). 2004 Mar 1;29(5):581-5; discussion 585. doi: 10.1097/01.brs.0000113869.13209.03.

    PubMed 15129077
  • Yildiz M, Durna Z, Akin S. Assessment of oral care needs of patients treated at the intensive care unit. J Clin Nurs. 2013 Oct;22(19-20):2734-47. doi: 10.1111/jocn.12035. Epub 2013 Mar 27.

    PubMed 23534462
  • Vollman, K., Sole, M. Lou, Quinn, B. 2017. "Endotracheal tube care and oral care practices for ventilated and non-ventilated patients". In Procedure Manual for High Acuity, Progressive, and Critical Care (pp. 32-39).

  • Thapa, B., Shrestha, R. 2019. "Nurses' knowledge and practice regarding oral care in intubated patients at selected teaching hospitals, Chitwan". International Journal of Innovative Science and Research Technology, 4(5).

  • Terzi, B., Kaya, N. 2011. "Nursing care of critically ill patients". Yoğun Bakım Dergisi.

  • Terezakis E, Needleman I, Kumar N, Moles D, Agudo E. The impact of hospitalization on oral health: a systematic review. J Clin Periodontol. 2011 Jul;38(7):628-36. doi: 10.1111/j.1600-051X.2011.01727.x. Epub 2011 Apr 7.

    PubMed 21470276
  • Sachdev M, Ready D, Brealey D, Ryu J, Bercades G, Nagle J, Borja-Boluda S, Agudo E, Petrie A, Suvan J, Donos N, Singer M, Needleman I. Changes in dental plaque following hospitalisation in a critical care unit: an observational study. Crit Care. 2013 Sep 4;17(5):R189. doi: 10.1186/cc12878.

    PubMed 24007571
  • Prendergast V, Kleiman C, King M. The Bedside Oral Exam and the Barrow Oral Care Protocol: translating evidence-based oral care into practice. Intensive Crit Care Nurs. 2013 Oct;29(5):282-90. doi: 10.1016/j.iccn.2013.04.001. Epub 2013 May 20.

    PubMed 23702324
  • Noddeskou LH, Hemmingsen LE, Hordam B. Elderly patients' and nurses' assessment of traditional bed bath compared to prepacked single units--randomised controlled trial. Scand J Caring Sci. 2015 Jun;29(2):347-52. doi: 10.1111/scs.12170. Epub 2014 Sep 6.

    PubMed 25196742
  • Miura K, Kadone H, Abe T, Koda M, Funayama T, Noguchi H, Kumagai H, Nagashima K, Mataki K, Shibao Y, Sato K, Kawamoto H, Sankai Y, Yamazaki M. Successful Use of the Hybrid Assistive Limb for Care Support to Reduce Lumbar Load in a Simulated Patient Transfer. Asian Spine J. 2021 Feb;15(1):40-45. doi: 10.31616/asj.2019.0111. Epub 2020 Feb 4.

    PubMed 32008308

Questions about this trial

What is this clinical trial studying?

A study of Intensive Care and Oral Care, run by Saglik Bilimleri Universitesi 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 20 Oct 2026. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 5 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oral Cavity Assessment (time frame: It will be filled 2 minutes after the end of the application.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06709183, which also lists 29 linked publications.

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 20 Oct 2026.

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