Jaw Muscle Pain Post Wisdom Molar Surgery

June 17, 2026 updated by: Gayathri Subramanian, Rutgers, The State University of New Jersey

Temporo-masseteric Nerve Block in Post-wisdom Tooth Extraction Pain- a Randomized Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study is designed as a parallel, blinded, randomized phase II pilot study to assess the ability of the Temporo-masseteric Nerve Block (TMNB) injection to reduce post-operative pain in patients who undergo removal of lower third molar/s under sedation. It is not known how often and in whom jaw muscle pain significantly contributes to post-operative pain, limitation in mouth opening, and function. and develop significant jaw muscle pain. Hence the study is designed to assess the development of such jaw muscle pain before testing the placebo-controlled TMNB intervention. Accordingly, 80 subjects who undergo lower third molar extractions under intravenous sedation are randomized to receive either the TMNB (standard-of-care local anesthetic, 1.8 ml 2% lidocaine with 1:100,000 epinephrine), or a placebo (TMNB injection technique, but with 1.8 ml of sterile isotonic saline instead) the day following their extraction/s should they report significant pain (≥5 on a scale of pain rating from 0 to 10) when the jaw muscles are 'palpated' or examined with firm finger pressure. The assessment will be repeated 15 minutes after the injection. On the other hand, those who report less pain (<5) to jaw muscle palpation will not receive any injection. The participant, TMNB administrator and the evaluator will be blinded from randomization assignment. All participants will fill out daily remote surveys administered through REDCap® that will assess peak NRS pain score for the previous 24 hours, limitation in mouth opening and function, oral health related quality of life, pain medication consumption, and adverse effects from pain medications. Patient responses will be collected remotely and will include patient-uploaded cropped selfies of spontaneous mouth-opening with a disposable millimeter ruler (Orastretch®) propped between the upper and lower incisors.

It is anticipated that approximately 50% of patients will develop significant jaw muscle pain following the procedure. Hence, of the 80 participants, 40 are anticipated to be eligible for randomization, with 20 participants receiving the placebo or the TMNB injection, respectively.

Participants will return for an in-person assessment on Day 8, will return unused medications and will get an opportunity to participate in a qualitative interview to interrogate their experience receiving the injection (those randomized to TMNB/placebo), and their recovery experience. The duration of participation is a week from undergoing the procedure.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • Rutgers School of Dental Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control
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
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.
Active Comparator: 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.
Drug: Temporo-masseteric Nerve Block Injection
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.
Other Names:
  • Twin Block
  • TMNB
Experimental: TMNB with dental local anesthetic
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
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.
Other Names:
  • Twin Block
  • TMNB

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Jaw Muscle Pain Reduction on palpation post-TMNB injections
Time Frame: Day 2 15 minutes post TMNB injection
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sustained Benefit from TMNB Injection- pain reduction
Time Frame: 24-, 48-, 72-, and 96- hours post-injection
Comparison of peak NRS pain score, the highest pain level as perceived by the participant collected for the preceding 24 hours.
24-, 48-, 72-, and 96- hours post-injection
Sustained Benefit from TMNB Injection- mouth opening
Time Frame: 24-, 48-, 72-, and 96- hours post-injection
Comparison of spontaneous maximum mouth opening, measured in millimeters
24-, 48-, 72-, and 96- hours post-injection
Opioid consumption to 'rescue' pain poorly responsive to recommended pain medication regimen
Time Frame: 8 Days
Compare need for rescue opioid medication among the three groups
8 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rutgers, The State University of New Jersey

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Dental and Craniofacial Research (NIDCR)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 23, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro2024001685

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Final results will be posted no later than 12 months after the trial's primary completion date and will include participant flow, demographic and baseline characteristics, outcomes and statistical analyses, adverse events, the protocol, statistical analysis plan and administrative information.

The PI will share the individual non-identified subject data no later than acceptance for the publication's main findings from the final data analysis or 18 months after completion of the study, whichever is earlier. Data to be posted will include the study protocol, reference to study publication of primary outcome variable, the data set in both SAS and ASCII formats, data dictionary and study specific de-identification notes.

IPD Sharing Time Frame

Deidentified data will be released within 12 months of primary completion date.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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