Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT03975920
Eligibility Criteria:
Inclusion Criteria:
* Between 18 to 30 years of age at time of enrollment;
* Willing to provide informed consent to be randomized to either using the device or not when having surgical removal of 3rd molars with moderate/deep sedation or general anesthesia;
* Requires surgical removal of bilateral mandibular 3rd molars with moderate/deep sedation or general anesthesia; concurrent maxillary 3rd molars removal allowed;
* American Society of Anesthesiologists (ASA) Physical Status category 1 (normal healthy patient) or Category 2 (patient with mild systemic disease);
* Available to be contacted for study purposes by e-mail, phone and/or text;
* Willing to provide contact information for one other person who will know the patient's whereabouts in the event the patient cannot be reached. This contact information must be different from the patient's contact information;
* Willing to comply with all study procedures and be available for the six month duration of data collection.
Exclusion Criteria:
* In the past 3 months, reports the presence of TMD pain in their temples, jaw joints or jaw muscles;
* Contraindication(s) for moderate/deep sedation or general anesthesia;
* Any condition or situation the surgeon determines that would prevent the patient from participating in this study;
* Inability to understand study procedures or provide consent in English;
* Device does not fit mandible;
* Supernumerary 3rd molars present.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
30 Years
Study:
NCT03975920
Study Brief:
Protocol Section:
NCT03975920