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 range

18 Years – 24 Years

Sex

ALL

See this in plain English?

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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