During mandibular 3rd molar (wisdom tooth) extractions, when a downward force is placed on the patient's jaw, the patient must tense his/her jaw muscles to oppose it. Patients under moderate/deep sedation or general anesthesia cannot tense their muscles to counter this downward force to prevent injury to the jaw including the temporomandibular joint (TMJ). Bite blocks hold the patient's mouth open but do not counter this downward force on the mandible. Currently, oral and maxillofacial surgeons (OMSs) when surgically removing 3rd molars (wisdom teeth) with moderate/deep sedation or general anesthesia have a dental assistant that stands behind the chair and places their hands on both sides of the jaw to support it and oppose the downward force on the patient's jaw during the extractions. It is hard for the dental assistant to maintain support while anticipating the direction and amount of force placed by the OMS on the patient's jaw during the surgical removal. This may explain the finding that almost a quarter of new onset TMD cases in young adults is associated with 3rd molar removal. This study will look at the use of a jaw support device to provide a stable counterforce to downward forces on the jaw, thus preventing jaw hyperextension and injury to the jaw.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
Yes |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years - 30 Years |
Gender | All |
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03975920 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
N/A |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
University of Minnesota |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
N/A |
Principal Investigator Affiliation | N/A |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
Overall Status | Recruiting |
Countries | United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Impacted Third Molar Tooth, Temporomandibular Disorder |
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