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Completed

NCT Number: NCT04827784

Auriculotemporal Nerve Block in TMJ 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.

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Key information

Conditions

Temporomandibular Joint Disorders Arthralgia of TMJ Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tokat Gaziosmanpasa University, Faculty of Dentistry

Tokat Province, 60100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

local anaesthetic injection

Procedure

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.

Primary outcomes

  1. Baseline Pain Intensity

    Time frame: At the initial visit before starting anesthetic administration.

    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.

  2. Post-injection Pain Intensity

    Time frame: At six months follow-up visit

    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.

  3. Change From Baseline Maximal Mouth Opening on Post-Injection Follow Up Visits

    Time frame: At the first week, fourth week and sixth month.

    All patients' maximal mouth opening were measured and recorded as the distance between upper and lower right central incisors.

Secondary outcomes

  1. Overall Satisfaction With The Applied Treatment

    Time frame: At the six-month follow-up visit

    Patients were asked dichotomously to define the ATNB as successful/unsuccessful, according to their experience. The patients' responses were recorded individually.

Sponsors and collaborators

Lead sponsor

Tokat Gaziosmanpasa University

Other

Registry information

Official study title

The Evaluation Of The Efficacy Of Auriculotemporal Nerve Block In Temporomandibular Disorders

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 1, 2021
Registry last updated
Apr 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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