[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100430102":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":45,"responsibleParty":63,"collaborators":66,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":26,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":26,"enrollmentInfo":78,"targetDuration":26,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Rutgers, The State University of New Jersey","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Twin Block with Local Anesthetic","ACTIVE_COMPARATOR","Following lower third molar extraction under intravenous sedation, the patient randomized to this arm with receive the Twin block local anesthetic nerve block using the standard dental local anesthetic, i.e,. 2% lidocaine with 1:100,000 epinephrine, on the day after extraction, if the patient has pain greater than or equal to 5 on 10 in their jaw-closer muscles (Numerical Pain rating scale).",[13],"Drug: Twin block local anesthetic nerve block using standard dental anesthetic",{"label":15,"type":16,"description":17,"interventionNames":18},"Twin Block with sterile normal saline","PLACEBO_COMPARATOR","Following lower third molar extraction under intravenous sedation, the patient randomized to this arm with receive the Twin block using sterile normal saline, on the day after extraction, if the patient has pain greater than or equal to 5 on 10 in their jaw-closer muscles (Numerical Pain rating scale).",[19],"Other: Twin block with placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Twin block local anesthetic nerve block using standard dental anesthetic","2% lidocaine with 1:100,000 epinephrine is the standard dental local anesthetic in universal use. This drug will be administered as the Twin block local anesthetic nerve block targeting the branches of the mandibular nerve supplying the temporalis and masseter muscles.",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Twin block with placebo","Instead of the standard dental anesthetic, sterile normal saline will be delivered using the Twin block injection",[15],[32],{"name":33,"affiliation":34,"role":35},"Gayathri Subramanian, PhD, DMD","Rutgers School of Dental Medicine, Newark NJ","PRINCIPAL_INVESTIGATOR",[37,41],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","973 972 3418","subramga@sdm.rutgers.edu",{"name":42,"role":38,"phone":43,"phoneExt":26,"email":44},"Brahmleen Kaur, DMD","973 972 3126","bk466@sdm.rutgers.edu",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Rutgers School of Dental Medicine","RECRUITING","Newark","New Jersey","07103","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-74.17237,40.73566,{"lat":58,"lon":57},[61],{"name":33,"role":38,"phone":62,"phoneExt":26,"email":40},"973-972-3418",{"type":35,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Gayathri Subramanian","Assistant Professor",[67],{"name":68,"class":6},"New Jersey Health Foundation","100430102","phase-2-twin-block-pain-medications-and-third-molar-extractions-100430102",false,"NCT04880707","Twin Block, Pain Medications and Third Molar Extractions","Myogenous Face Pain Following Third Molar Extractions Under Intravenous Sedation","Inclusion Criteria:\n\n* All patients requiring extraction\u002Fs of at least 1 lower wisdom (third) molar that is partially\u002Ffully 'impacted', under intravenous sedation, are eligible to participate in this study so long as they\n\n  1. are older than 18 years of age,\n  2. are healthy,\n  3. have no cognitive\u002Fintellectual disability,\n  4. have no past\u002Frecent pain or reduced range of motion in their jaw joint\u002F muscle complex, no trauma or surgery in their jaw region.\n  5. have an electronic device such as a smart phone or a tablet\u002F computer with internet connection.\n  6. are willing to participate in the study and not be excluded by the following criteria below.\n\nExclusion Criteria:\n\n* Any patients, even if satisfying the criteria above, may not take part if they have any of the following:\n\n  1. Compromised ability to guard their self-interest, for e.g., prisoners, children, pregnant women, patients with intellectual\u002Fcognitive disability are not enrolled in the study.\n  2. Those patients who present with infection\u002Finflammation involving the third molars slated for extractions, on the day of their procedure, may not take part in the study.\n  3. In addition, those who have had opioid pain medication\u002Fs in the past to address short-term or long-standing pain, or those who are on long term prescription of anti-inflammatory pain medication, are unable to participate.\n  4. Those with long standing pain of the jaw joint or muscles.\n  5. Finally, those patients who are allergic to\u002Funable to tolerate either the dental local anesthetic or its components, opioids, acetaminophen ('Tylenol') or ibuprofen ('Motrin' or 'Advil') also may not take part in the study.","ALL","18 Years",{"count":79,"type":80},48,"ESTIMATED","INTERVENTIONAL",[83],"PHASE2","Each year, over 3.5 million, mostly, healthy young adults, have their third molar teeth ('wisdom teeth') removed under sedation and are often given opioid prescriptions for managing their pain. Wisdom molar removal is one of the most common reasons for opioid prescriptions to be given to adolescents. There is a national thrust to reduce both the dose and the duration of such opioid prescriptions because even short-term opioid exposures increase risk for narcotic addiction and misuse. Non-opioid options to manage pain will still allow for sufficient pain control without risking addiction, and hence, a fundamental component of our response to combat the current national opioid crisis.\n\nThe investigators are going to study a promising option- the Twin Block dental anesthetic injection. The Twin block involves injecting the standard dental numbing medication in a way that 'numbs' the 'jaw-clencher' muscles on the side of the face. The investigators found that the Twin block relieved jaw pain stemming from these muscles, in a quick and sustained manner, even in patients whose pain following wisdom tooth removal primarily came from 'taut' and tender jaw-clencher muscles. However, what is not known is- how often do patients who have their wisdom teeth removed under sedation, end up in significant pain from taut and tender jaw-clencher muscles? Will using the twin block effectively reduce pain in such patients? In this pilot study, the investigators will examine wisdom molar extraction patients one day after their procedure. Those with significant pain (pain rated ≥ 5 on a 0-10 scale) in their jaw-clencher muscles, will get either the Twin block injection or a placebo. The investigators will track both 1) pain before and after the injection, and 2) pain medication usage over a 7-day period to see if both pain and opioid dosage come down with the Twin block. This study can support a simple, safe and inexpensive means to reduce pain after a common procedure.",[86],"Acute Pain",[88,89,90],"Twin block","Prescription opioids","Acute post-extraction pain","2026-06-17",{"date":93,"type":94},"2026-06-22","ACTUAL",{"date":96,"type":94},"2024-03-11",{"date":98,"type":80},"2026-12",{"name":5,"class":6},1]