[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600211":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":37,"centralContacts":38,"locations":48,"responsibleParty":62,"collaborators":66,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":37,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":37,"enrollmentInfo":79,"targetDuration":37,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":90,"overallStatus":93,"whyStopped":37,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Rutgers, The State University of New Jersey","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Control","ACTIVE_COMPARATOR","Participants whose jaw muscle pain to palpation is \\\u003C5 on Numerical Pain Rating Scale (NRS) the day after lower wisdom molar removal under sedation will be recommended post-operative pain management with a fixed interval dosing of ibuprofen 600 mg along with acetaminophen 325 mg taken every 6 hours for the first 72 hours post-procedure, after which they are encouraged to take prn dosing.",[13],"Drug: Oral Pain Medications only",{"label":15,"type":10,"description":16,"interventionNames":17},"TMNB with Placebo","Participants whose jaw muscle pain to palpation is 5 or higher on on Numerical Pain Rating Scale (NRS) the day after lower wisdom molar removal under sedation will be randomized to either placebo (sterile saline) or to the dental local anesthetic. The placebo will be delivered as the Temporo-masseteric Nerve Block injection. The randomization is blind to the participant and to the investigator administering the injection. The participants will be recommended post-operative pain management with a fixed interval dosing of ibuprofen 600 mg along with acetaminophen 325 mg taken every 6 hours for the first 72 hours post-procedure, after which they are encouraged to take prn dosing.",[18],"Drug: Temporo-masseteric Nerve Block Injection",{"label":20,"type":21,"description":22,"interventionNames":23},"TMNB with dental local anesthetic","EXPERIMENTAL","Participants whose jaw muscle pain to palpation is 5 or higher on on Numerical Pain Rating Scale (NRS) the day after lower wisdom molar removal under sedation will be randomized to either placebo (sterile saline) or to the dental local anesthetic. The dental local anesthetic (2% lidocaine with 1:100,000 epinephrine) will be delivered as the Temporo-masseteric Nerve Block injection. The randomization is blind to the participant and to the investigator administering the injection. The participants will be recommended post-operative pain management with a fixed interval dosing of ibuprofen 600 mg along with acetaminophen 325 mg taken every 6 hours for the first 72 hours post-procedure, after which they are encouraged to take prn dosing.",[18],[25,33],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Temporo-masseteric Nerve Block Injection","The TMNB injection\u002Fplacebo will be administered by the Principal Investigator. The injection will only be delivered on Day 2 on the side\u002Fs of significant jaw muscle pain. Following disinfection of skin overlying the suprazygomatic injection site, a single carpule of 1.8 ml 2% lidocaine with 1:100,000 epinephrine will be delivered using a 25- or 27- gauge 30 mm needle). The injection site will be approximately a centimeter above the zygomatic arch, and a centimeter behind the palpable posterior border of the frontal process of the zygomatic bone. The needle will be directed at a 45-degree downward angle, directed medially along the coronal plane. At the depth of insertion of the needle, the local anesthetic\u002Fplacebo will be delivered.",[15,20],[31,32],"TMNB","Twin Block",{"type":26,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"Oral Pain Medications only","For participants with jaw muscle pain to palpation \\\u003C5 NRS score, no additional injection will be given. The participant will take the recommended pain medications as described.",[9],null,[39,44],{"name":40,"role":41,"phone":42,"phoneExt":37,"email":43},"Gayathri D Subramanian, PhD, DMD","CONTACT","7328247241","subramga@sdm.rutgers.edu",{"name":45,"role":41,"phone":46,"phoneExt":37,"email":47},"Samuel Y. P. Quek, DMD, MPH","732 570 1996","queksa@rutgers.edu",[49],{"facility":50,"status":37,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":37},"Rutgers School of Dental Medicine","Newark","New Jersey","07103","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-74.17237,40.73566,{"lat":60,"lon":59},{"type":63,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":37,"oldOrganization":37},"PRINCIPAL_INVESTIGATOR","Gayathri Subramanian","Associate Professor",[67],{"name":68,"class":69},"National Institute of Dental and Craniofacial Research (NIDCR)","NIH","100600211","phase-2-jaw-muscle-pain-post-wisdom-molar-surgery-100600211",false,"NCT07094542","Jaw Muscle Pain Post Wisdom Molar Surgery","Temporo-masseteric Nerve Block in Post-wisdom Tooth Extraction Pain- a Randomized Study","Inclusion Criteria:\n\nAll patients recommended 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* are 18 years or older,\n* are healthy,\n* have no cognitive\u002Fintellectual disability,\n* 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* have an electronic device such as a smart phone or a tablet\u002F computer with internet connection.\n* are willing to participate in the study and not be excluded by the following criteria below.\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* 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* 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* Those who have had opioid pain medication\u002Fs in the past 3 months 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* Those with long standing painful limitation of movement of the jaw joint or muscles.\n* Those patients who are allergic to\u002Funable to tolerate either the dental local anesthetic or its components, opioids, acetaminophen or ibuprofen also may not take part in the study","ALL","18 Years",{"count":80,"type":81},80,"ESTIMATED","INTERVENTIONAL",[84],"PHASE2","The proposed design is a triple-blind, placebo-controlled randomized prospective phase II trial to assess the feasibility of employing the Temporo-masseteric Nerve Block (TMNB) injection to decrease jaw muscle pain, overall pain, improve mouth opening and minimize pain medication consumption. 80 participants undergoing lower third molar removal under sedation will be enrolled. Those who develop significant jaw muscle pain on the following day will be randomized to receive either the TMNB injection or a placebo. Daily ecological momentary assessments (EMAs) will be collected reflecting elements of patient experience for all participants. On Day 8, participants return for an end-of-study evaluation and return their unused pain medications. Up to 40 participants who are randomized to receive TMNB\u002Fplacebo will be recruited to participate in a qualitative interview regarding their experience.",[87,88,89],"Post Operative Pain","Impacted Third Molar Tooth","Muscle Pain",[91,92],"Temporo-masseteric Nerve Block","Jaw muscle pain","NOT_YET_RECRUITING","2026-06-17",{"date":96,"type":97},"2026-06-18","ACTUAL",{"date":99,"type":81},"2026-09",{"date":101,"type":81},"2030-05",{"name":5,"class":6},1]