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NCT Number: NCT07806812

Pilot Study of the Sage Guard for Oral Cavity Protection

During placement of a breathing tube, a soft device will be placed in the mouth to help keep the teeth apart and hold the tongue out of the way. This device is designed to help protect the mouth and throat from injury caused by biting, which can lead to swelling or infection. It may also help keep the breathing tube in place and prevent damage to the tube from being bitten. The study will evaluate how safe the device is and how easy it is for healthcare providers to use in patients receiving care in the Intensive Care Unit (ICU).

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Key information

Conditions

Intubated Patients

Age range

13 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

A device will be placed in participants that are intubated in the ICU. The device will remain in place for up to 21 days, removal of the device will coincide with extubation. Surveys will be completed by experienced healthcare providers in the ICU to answer work related questions and provide a baseline for oral trauma in the ICU while intubated. Bedside nurses will be asked to answer questions about their experience with the device during participant use to understand ease of usability and integration into the workflow.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sage Guard oral protection device

Device

The study device is a single-use mouth device made of a soft plastic material (thermoplastic polyurethane). It has side bite blocks that help keep the teeth apart, a center support that helps hold the breathing tube in place, and tongue guards that help protect the tongue from injury. The device is designed for use in patients with an endotracheal (breathing) tube to help prevent injury to the mouth and tongue caused by biting and to help keep the breathing tube stable.

Primary outcomes

  1. Incidence of oral trauma in intubated patients

    Time frame: Daily assessment up to Day 21

    The occurrence of oral injuries, including injury to the tongue, lips, cheeks, gums, or other oral tissues, during the period of endotracheal intubation. The incidence of oral trauma will be compared between patients managed with the study device and those receiving standard care.

  2. Incidence of endotracheal tube displacement in intubated patients

    Time frame: Daily assessment up to Day 21

    The occurrence of endotracheal tube movement from its intended position during the period of intubation. The incidence of tube displacement will be compared between patients managed with the study device and those receiving standard care.

  3. Incidence of endotracheal tube damage in intubated patients

    Time frame: Daily assessment up to Day 21

    The occurrence of endotracheal tube damage during the period of intubation. The incidence of tube damage will be compared between patients managed with the study device and those receiving standard care.

Secondary outcomes

  1. Frequency of movement of study device position during endotracheal intubation

    Time frame: Daily assessment up to Day 21

    The occurrence of movement of the study device from its intended position during the period of endotracheal intubation. The frequency of device displacement events will be recorded.

  2. Likert Scale Scores of study device use by bedside nursing staff

    Time frame: Daily assessment up to Day 21

    Feasibility will be assessed by nursing staff using a standardized questionnaire evaluating ease of device placement, maintenance, removal, and integration into routine patient care workflow. A Likert scale is scored by assigning numbers to each answer choice. You then add up or average these numbers to turn soft feelings into hard data. A standard five-point scale gives a score of 1 to 5 for each question - Higher totals mean more of that trait or feeling.

Study contacts

Contact information is provided by the study sponsor or research team.

Amir Taha, DDS

CONTACT

Jesus A. Valdez, DDS

CONTACT

[email protected]

704-355-4841

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Obsolete Engineering Co.

Registry information

Official study title

Pilot Feasibility Study to Evaluate the Efficacy, Safety, and Usability of the Sage Guard for Protecting the Vital Structures of the Oral Cavity

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 8, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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