Jaw Muscle Pain Post Wisdom Molar Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-31

Study Completion Date

2030-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Reducing Pain From Wisdom Molar Extractions

NCT05335070

Acute Pain

RECRUITING PHASE2

Twin Block, Pain Medications and Third Molar Extractions

NCT04880707

Acute Pain

RECRUITING PHASE2

Dental Pain Study of Analgesics in Patients Undergoing Molar Removal

NCT03652818

Dental Pain

COMPLETED PHASE2

Pain Control After Orthognathic Surgery

NCT01418183

Postoperative Pain

UNKNOWN NA

Distolingual Infiltration Verses Conventional Nerve Block in Mandibular Third Molar Extraction

NCT07296926

Pain (Visceral, Somatic, or Neuropathic)

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Post Operative Pain Impacted Third Molar Tooth Muscle Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Oral Pain Medications only

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Temporo-masseteric Nerve Block Injection

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Temporo-masseteric Nerve Block Injection

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

TMNB Twin Block

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No