CompletedNot Applicable

Feasibility Testing of a New Way to Support the Jaw During 3rd Molar Extractions

United States19 participantsStarted 2018-06-01

Plain-language summary

Cross sectional observational study to assess the feasibility of using the functional prototype of the restful jaw support device to support the jaw when extracting mandibular 3rd molars using moderate/deep sedation. An additional meeting(s) will occur, after the oral and maxillofacial surgeons (OMS) have completed all treatment procedures utilizing the device and surveys are completed, to provide feedback on how the device performed.

Who can participate

Age range18 Years – 24 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Is between 18 to 24 years of age. * Requires surgical removal of bilateral mandibular 3rd molars (concurrent maxillary 3rd molar extractions allowed). * Will consent to have 3rd molar surgical removal with the device supporting the mandible. * Indication for moderate/deep sedation and medically able to tolerate sedation. * American Society of Anesthesiologists (ASA) Physical Status Category I (healthy patient) and Category II (patients with mild systemic disease). Exclusion Criteria: • Any condition or situation that the surgeon feels would prevent the patient from participating in the study.

What they're measuring

The feasibility will be assessed by query of the surgeons utilizing the device (questionnaire). This will be done after 4 patient experiences in conjunction with surgical procedure.

Timeframe: 3-6 months

Trial details

NCT IDNCT03512769

SponsorUniversity of Minnesota

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2018-12-30

View on ClinicalTrials.gov More Impacted Third Molar Tooth trials