Oral Device Clinical Trial

Launched by NATIONWIDE CHILDREN'S HOSPITAL · Aug 25, 2021

Keywords

ClinConnect Summary

This study is testing a new safety device called LabraGuard, used during mouth surgeries to protect the lips and help keep the surgical area clear. The device is a sterile, soft silicone tool that is placed in the mouth during the operation. Researchers want to learn how well LabraGuard works across children and young adults up to 21 years old, focusing on safety and how the device affects the surgeon’s view of the area.

Who can participate? People up to 21 years old who are having a planned oral surgery where the lips might be at risk, with the procedure done by an ENT doctor or a dental surgeon. You or your guardian must give consent to be in the study. Exclusions include an allergy to silicone or a case where the device cannot fit properly. If eligible, you would use LabraGuard during the surgery, and researchers will record the surgeon’s rating of how well they could see the surgical area. No medical records beyond the surgery date are being collected, and the trial is currently enrolling by invitation at Nationwide Children’s Hospital in Columbus, Ohio. Results are not yet available.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subjects 21 years of age and under
• • Having a surgical procedure done through the mouth where the lips are at risk of injury
• • Performed by attendings from either the Otolaryngology department or the Dental department.
• • Subject/Subject's guardian provides consent to be in the study
• Exclusion Criteria:
• • Allergy to silicone
• • Unable to achieve good fit