Jaw Muscle Pain Post Wisdom Molar Surgery

NCT07094542 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: Pro2024001685
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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/placebo will be recruited to participate in a qualitative interview regarding their experience.

Conditions

Muscle Pain; Post Operative Pain; Impacted Third Molar Tooth

Keywords

Temporo-masseteric Nerve Block; Jaw muscle pain

Outcome Measures

Primary Outcomes (1)

• Jaw Muscle Pain Reduction on palpation post-TMNB injections

  To assess the effect of TMNB injection on the Numerical Pain Rating Scale (NRS) corresponding to Jaw muscle pain-to-palpation reported by the participant, when assessed 15 minutes post-injection.

  Day 2 15 minutes post TMNB injection

Secondary Outcomes (3)

• Sustained Benefit from TMNB Injection- pain reduction

  24-, 48-, 72-, and 96- hours post-injection

• Sustained Benefit from TMNB Injection- mouth opening

  24-, 48-, 72-, and 96- hours post-injection

• Opioid consumption to 'rescue' pain poorly responsive to recommended pain medication regimen

  8 Days

Study Arms (3)

Control

ACTIVE COMPARATOR

Participants whose jaw muscle pain to palpation is \<5 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.

Drug: Oral Pain Medications only

TMNB with Placebo

ACTIVE COMPARATOR

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.

Drug: Temporo-masseteric Nerve Block Injection

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.

Drug: Temporo-masseteric Nerve Block Injection

Interventions

Temporo-masseteric Nerve Block Injection DRUG

The TMNB injection/placebo will be administered by the Principal Investigator. The injection will only be delivered on Day 2 on the side/s 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/placebo will be delivered.

Also known as: TMNB, Twin Block

TMNB with Placebo; TMNB with dental local anesthetic

Oral Pain Medications only DRUG

For participants with jaw muscle pain to palpation \<5 NRS score, no additional injection will be given. The participant will take the recommended pain medications as described.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients recommended extraction/s of at least 1 lower wisdom (third) molar that is partially/fully 'impacted' under intravenous sedation, are eligible to participate in this study so long as they
• are 18 years or older,
• are healthy,
• have no cognitive/intellectual disability,
• have no past/recent pain or reduced range of motion in their jaw joint/ muscle complex, no trauma or surgery in their jaw region.
• have an electronic device such as a smart phone or a tablet/ computer with internet connection.
• are willing to participate in the study and not be excluded by the following criteria below.

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Compromised ability to guard their self-interest, for e.g., prisoners, children, pregnant women, patients with intellectual/cognitive disability are not enrolled in the study.
• Those patients who present with infection/inflammation involving the third molars slated for extractions, on the day of their procedure, may not take part in the study.
• Those who have had opioid pain medication/s 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.
• Those with long standing painful limitation of movement of the jaw joint or muscles.
• Those patients who are allergic to/unable to tolerate either the dental local anesthetic or its components, opioids, acetaminophen or ibuprofen also may not take part in the study

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

Rutgers School of Dental Medicine

Newark, New Jersey, 07103, United States

Location

Related Publications (5)

• Subramanian G, Quek SYP. The Temporo-Masseteric Nerve Block (TMNB) for Alleviating Acute Postextraction Masticatory Myalgia: A Case Series. Anesth Prog. 2025 Mar 12;72(1):37-42. doi: 10.2344/24-0001.

  PMID: 40657832 BACKGROUND

• Subramanian G, Makhija D, Ananthan S, Stitik TP, Quek SYP. Safety, efficacy, and mechanism of action of the temporo-masseteric nerve block. J Oral Facial Pain Headache. 2024 Jun;38(2):68-73. doi: 10.22514/jofph.2024.014. Epub 2024 Jun 12.

  PMID: 39801096 BACKGROUND

• Quek SYP, Gomes-Zagury J, Subramanian G. Twin Block in Myogenous Orofacial Pain: Applied Anatomy, Technique Update, and Safety. Anesth Prog. 2020 Jun 1;67(2):103-106. doi: 10.2344/anpr-67-01-03.

  PMID: 32633773 BACKGROUND

• Kanti V, Ananthan S, Subramanian G, Quek SYP. Efficacy of the twin block, a peripheral nerve block for the management of chronic masticatory myofascial pain: A case series. Quintessence Int. 2017 Oct 6:725-729. doi: 10.3290/j.qi.a39094. Online ahead of print.

  PMID: 28990015 BACKGROUND

• Ananthan S, Kanti V, Zagury JG, Quek SYP, Benoliel R. The effect of the twin block compared with trigger point injections in patients with masticatory myofascial pain: a pilot study. Oral Surg Oral Med Oral Pathol Oral Radiol. 2020 Mar;129(3):222-228. doi: 10.1016/j.oooo.2019.09.014. Epub 2019 Oct 13.

  PMID: 32009005 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Myalgia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain

Central Study Contacts

Gayathri D Subramanian, PhD, DMD

CONTACT

7328247241; subramga@sdm.rutgers.edu

Samuel Y. P. Quek, DMD, MPH

CONTACT

732 570 1996; queksa@rutgers.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participant and investigators will be blinded to the treatment assignment- namely, the Temporo-masseteric Nerve Block using a placebo (sterile saline) or dental local anesthetic medication
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: July 30, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): May 1, 2030
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Deidentified data will be released within 12 months of primary completion date.
• Access Criteria: Upon written request to the PI, survey instruments or other materials developed for use during the clinical trial will be made electronically available to other researchers.

Locations

US (1)