Tongue Brush (Orabrush) for Reducing Aspiration Pneumonia in Stroke Patients (StrOra)

March 15, 2026 updated by: Leona Möller, University Hospital Marburg
The investigators conduct a controlled prospective experimental intervention study to examine whether the use of a tongue brush (Orabrush) can improve the rate of aspiration pneumonia and dysphagia in patients with ischemic stroke. Secondary outcomes include the impact on bacterial tongue colonization, the Tongue Coating Index, and the length of stay of the patients.The patients will be recruited in the Stroke Unit of the Department of Neurology from November 2024 until approximately October 2026.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

As part of a prospective controlled experimental intervention study, patients with ischemic stroke will be recruited in the Stroke Unit of the University Hospital Marburg, who are admitted between November 2024 and approximately October 2026. The primary objective of this study is to investigate the impact of a tongue brush (Orabrush) on the rate of aspiration pneumonia and dysphagia. Secondary outcomes include the analysis of bacterial tongue colonization, the Tongue Coating Index, and the length of stay of the patients. Key study parameters include the aspiration rate, the EAT-10, the GUSS, a tongue swab, and a photograph of the tongue to determine the Tongue Coating Index. Data will be collected on the day of admission and after a duration of 3-5 days. The study has been approved by the relevant ethics committee.

Study Type

Interventional

Enrollment (Actual)

252

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hesse
      • Marburg, Hesse, Germany, 35043
        • University Hospital Marburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ischemic stroke and admission on the stroke unit at the University Hospital Marburg
  • minimum age: 18 years
  • patient is able to consent
  • consent has been obtained

Exclusion Criteria:

  • surgery in the oral-pharyngeal region
  • irradiated patient with a history of tumor in the head and neck region
  • missing compliance
  • intake of medications with saliva-altering side effects, existing desire to have children, or pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Routine Care Group
Patients in the Routine Care Group receive standard speech therapy during their inpatient stay.
Experimental: Tongue Brush Group
Patients in the Tongue Brush Group receive standard speech therapy and additionally use the tongue brush twice daily for a period of 3-5 days during their inpatient stay.
Device: Tongue Brush (Orabrush)
Patients in this group uses the Tongue Brush (Orabrush) 2 times a day for a duration for 3-5 days until the follow-up-screening takes place.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Aspiration Pneumonias
Time Frame: From the date of first admission until discharge, with the occurrence of aspiration, within max. 4 weeks pneumonia documented at any point during the inpatient stay.
Evaluation of the Impact of a Tongue Brush on the Incidence of Aspiration Pneumonia in Patients with Ischemic Stroke.
From the date of first admission until discharge, with the occurrence of aspiration, within max. 4 weeks pneumonia documented at any point during the inpatient stay.
Severity of dysphagia measured by EAT-10 [score from 0-40]
Time Frame: EAT-10 is assessed on the day of admission and after a period of 3-5 days.
This study aims to investigate whether the use of a tongue brush has an effect on the severity of dysphagia in ischemic stroke patients compared to the control group. The severity of dysphagia is quantified using the dysphagia screening tool EAT-10. The EAT-10 can have a score ranging from 0 to 40, with the severity of dysphagia increasing as the score rises.
EAT-10 is assessed on the day of admission and after a period of 3-5 days.
Severity of dysphagia measured by GUSS [score from 0-20]
Time Frame: GUSS is assessed on the day of admission and after a period of 3-5 days.
This study aims to investigate whether the use of a tongue brush has an effect on the severity of dysphagia in ischemic stroke patients compared to the control group. The severity of dysphagia is quantified using the dysphagia screening tool GUSS. The GUSS can have a score ranging from 0 to 20, with the severity of dysphagia increasing as the score decreases.
GUSS is assessed on the day of admission and after a period of 3-5 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Winkel Tongue Coating Index [Score from 0 to 12]
Time Frame: The WTCI of the patients is determined on the day of admission and after 3-5 days.
Determination of the Winkel Tongue Coating Index (WTCI) in ischemic stroke patients. For this purpose, the tongue is divided into six equal-sized quadrants, and each quadrant is assigned a score from 0 to 2, depending on the severity of tongue coating. In total, a score ranging from a minimum of 0 to a maximum of 12 points can be achieved across the six quadrants. A low score indicates very little tongue coating, while a high score reflects a significant amount of tongue coating.
The WTCI of the patients is determined on the day of admission and after 3-5 days.
Microbiological quantification of the tongue's bacterial load through the determination of colony-forming units (CFU)
Time Frame: Bacterial tongue colonization is assessed in the patients through swabbing on the day of admission and after 3-5 days.
A swab of the tongue is taken from patients with ischemic stroke, and a microbiological quantification of the bacterial load is performed. Depending on the level of CFU, the bacterial load is categorized into the semiquantitative parameters 'low,' 'moderate,' and 'high'.
Bacterial tongue colonization is assessed in the patients through swabbing on the day of admission and after 3-5 days.
Length of in-hospital stay in days
Time Frame: Duration of in-hospital stay, measured from the admission date to the discharge date, during the inpatient treatment period. The average length of stay is approximately 6 days, so a maximum time frame of 30 days is chosen for the survey.
It is investigated how many days patients with ischemic stroke stay in the hospital and whether there is a significant difference in the length of stay between the control and intervention groups.
Duration of in-hospital stay, measured from the admission date to the discharge date, during the inpatient treatment period. The average length of stay is approximately 6 days, so a maximum time frame of 30 days is chosen for the survey.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Marburg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2024

Primary Completion (Actual)

January 31, 2026

Study Completion (Actual)

January 31, 2026

Study Registration Dates

First Submitted

November 27, 2024

First Submitted That Met QC Criteria

January 2, 2025

First Posted (Actual)

January 9, 2025

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 15, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-227 BO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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