Can a simple mouth guard shield ICU patients from Tube-Related injuries?
NCT ID NCT07806812
First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time
Summary
This study tests a soft plastic mouth device called Sage Guard in intensive care patients who have a breathing tube. The device aims to keep teeth apart, hold the tongue safely, and stabilize the tube, potentially reducing injuries from biting and tube movement. Researchers will compare outcomes like mouth trauma, tube displacement, and tube damage between patients using the device and those receiving standard care. The study also checks how easy the device is for healthcare providers to use.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Sage Guard, a single-use soft plastic mouth device with bite blocks, a center support, and tongue guards, designed for intubated patients
- What this could lead to
- If it works, this device could reduce mouth injuries and breathing tube problems in ICU patients, improving safety and comfort during ventilation.
- What could go wrong
- This is a small pilot study, so results may not apply broadly. The device might not fit all patients or could cause discomfort or allergic reactions.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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13 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Intubated ICU patients on mechanical ventilation * 2 sets of opposing teeth that occlude on both left and right sides * Attending physician requested a dental evaluation as part of the patient's care Exclusion Criteria: * Active oral infection or trauma preventing safe device placement * Known allergy to thermoplastic polyurethane (TPU) * Severe facial or jaw trauma incompatible with device placement * Mixed dentition, primary dentition, and edentulous patients
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Atrium Health - Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
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