- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04827784
Auriculotemporal Nerve Block in TMJ Disorders
March 30, 2021 updated by: Aras Erdil, Tokat Gaziosmanpasa University
The Evaluation Of The Efficacy Of Auriculotemporal Nerve Block In Temporomandibular Disorders
The retrospective study aimed to evaluate the efficacy of the Auriculotemporal Nerve Block (ATNB) in achieving unrestricted mouth opening amount and in reducing the pain scores in those patients diagnosed with disc displacement with (DDWR) and without reduction (DDWOR) according to the Diagnostic Criteria for Temporomandibular Disorders, who could not benefit from noninvasive methods but did not want further invasion.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
The records of 410 patients referred to the Department of Oral and Maxillofacial Surgery with TMD symptoms were reviewed to determine the treatment modalities used and their outcomes.
The subjects were examined and diagnosed according to the Turkish translation version of The Diagnostic Criteria for Temporomandibular Disorders (DC/TMD-Axis 1 questionnaire and examination form).
The pain intensity, maximal mouth opening (MMO) amounts, and self-reported outcome variables of twenty-two patients who underwent non-invasive therapies (occlusal stabilization splints, behavioral modifications, physical therapy, pharmacotherapy) but did not benefit from them and volunteered for the ATNB instead of invasive therapies (arthrocentesis, arthroscopy, and discectomy) were also evaluated.
Prior to the ATNB, written informed consent was obtained from each participant.
Also, each participant was warned about complications of the ATNB before the administration, such as hematoma at the injection site, positive aspiration, and temporary anesthesia of the facial nerve.
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tokat, Turkey, 60100
- Tokat Gaziosmanpasa University, Faculty of Dentistry
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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
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Underwent non-invasive therapies (occlusal stabilization splints, behavioral modifications, physical therapy, pharmacotherapy) but did not benefit from them and volunteered for the ATNB instead of invasive therapies (arthrocentesis, arthroscopy, and discectomy).
Exclusion Criteria:
Patients with
- Symptoms of the diseases possibly related to TMD (e.g., fibromyalgia, hypothyroidism, scleroderma, rheumatoid arthritis)
- Orofacial disorders that might have been responsible for the TMD symptoms (e.g., neuralgia, migraine, myositis, trauma, neuropathic pain, infections)
- Complications due to ATNB (e.g., temporary facial nerve palsy, hematoma, positive aspiration)
- History of invasive therapies or TMJ surgeries
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: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: Auriculotemporal Nerve Block Administration
A total of 3 doses of Auriculotemporal Nerve Block (ATNB) were administered to involved participants.
Local anesthetic solutions containing Articaine Hydrochloride (80 mg / 2 ml) and epinephrine bitartrate (0.02 mg / 2 ml) were used for ATNB application.
The injections were repeated on follow-up visits in the first and fourth weeks.
The maximal mouth opening amounts, pain intensity values (via VAS scale), and self-reported outcomes were evaluated at the pre-injection, first week, fourth week, and sixth-month follow-up controls.
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The head and neck of the condyle were detected by palpating the pretragal area.
Then, the needle was inserted anterior to the junction of the tragus and the lobule.
After 0.5 ml the solution was subcutaneously infiltrated, the needle was protruded until it touched the neck of the condyle.
Aspiration was performed to avoid intravenous injections, and the remaining solution was injected thereafter.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Baseline Pain Intensity
Time Frame: At the initial visit before starting anesthetic administration.
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Pain intensity was measured using a 10-point Visual Analog Scale (VAS), in which 0 referred to 'no pain', 5 referred to 'moderate pain,' and 10 referred to 'excruciating pain'.
The patients were asked to mark their pain intensities on VAS scale.
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At the initial visit before starting anesthetic administration.
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Post-injection Pain Intensity
Time Frame: At six months follow-up visit
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Pain intensity was measured using a 10-point Visual Analog Scale (VAS), in which 0 referred to 'no pain', 5 referred to 'moderate pain,' and 10 referred to 'excruciating pain'.
The patients were asked to mark their pain intensities on VAS scale.
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At six months follow-up visit
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Change From Baseline Maximal Mouth Opening on Post-Injection Follow Up Visits
Time Frame: At the first week, fourth week and sixth month.
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All patients' maximal mouth opening were measured and recorded as the distance between upper and lower right central incisors.
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At the first week, fourth week and sixth month.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Overall Satisfaction With The Applied Treatment
Time Frame: At the six-month follow-up visit
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Patients were asked dichotomously to define the ATNB as successful/unsuccessful, according to their experience.
The patients' responses were recorded individually.
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At the six-month follow-up visit
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
- NASCIMENTO, Mirella Marques Mercês do, et al. Anesthetic blockage of the auriculotemporal nerve and its clinical implications. Odontologia Clínico-Científica (Online), 2011, 10.2: 143-146.
- Ayesh EE, Ernberg M, Svensson P. Effects of local anesthetics on somatosensory function in the temporomandibular joint area. Exp Brain Res. 2007 Jul;180(4):715-25. doi: 10.1007/s00221-007-0893-4. Epub 2007 Feb 15.
- Nascimento MM, Vasconcelos BC, Porto GG, Ferdinanda G, Nogueira CM, Raimundo RD. Physical therapy and anesthetic blockage for treating temporomandibular disorders: a clinical trial. Med Oral Patol Oral Cir Bucal. 2013 Jan 1;18(1):e81-5. doi: 10.4317/medoral.17491.
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 (ACTUAL)
January 15, 2020
Primary Completion (ACTUAL)
September 23, 2020
Study Completion (ACTUAL)
December 7, 2020
Study Registration Dates
First Submitted
March 27, 2021
First Submitted That Met QC Criteria
March 30, 2021
First Posted (ACTUAL)
April 1, 2021
Study Record Updates
Last Update Posted (ACTUAL)
April 1, 2021
Last Update Submitted That Met QC Criteria
March 30, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Pain
- Neurologic Manifestations
- Musculoskeletal Diseases
- Muscular Diseases
- Stomatognathic Diseases
- Jaw Diseases
- Craniomandibular Disorders
- Mandibular Diseases
- Myofascial Pain Syndromes
- Arthralgia
- Disease
- Joint Diseases
- Temporomandibular Joint Disorders
- Temporomandibular Joint Dysfunction Syndrome
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Anesthetics, Local
Other Study ID Numbers
- GaziosmanpasaU2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The data regarding participants were made available in the manuscript
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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