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Auriculotemporal Nerve Block in TMJ Disorders

Primary Purpose

Temporomandibular Joint Disorders, Arthralgia of TMJ

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
local anaesthetic injection
Sponsored by
Tokat Gaziosmanpasa University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Temporomandibular Joint Disorders focused on measuring Auriculotemporal nerve block, Temporomandibular disorders, Physiotherapy, Anesthesia, Local

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tokat Gaziosmanpasa University, Faculty of Dentistry

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Auriculotemporal Nerve Block Administration

Arm Description

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.

Outcomes

Primary Outcome Measures

Baseline Pain Intensity
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.
Post-injection Pain Intensity
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.
Change From Baseline Maximal Mouth Opening on Post-Injection Follow Up Visits
All patients' maximal mouth opening were measured and recorded as the distance between upper and lower right central incisors.

Secondary Outcome Measures

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

Full Information

First Posted
March 27, 2021
Last Updated
March 30, 2021
Sponsor
Tokat Gaziosmanpasa University
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1. Study Identification

Unique Protocol Identification Number
NCT04827784
Brief Title
Auriculotemporal Nerve Block in TMJ Disorders
Official Title
The Evaluation Of The Efficacy Of Auriculotemporal Nerve Block In Temporomandibular Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 15, 2020 (Actual)
Primary Completion Date
September 23, 2020 (Actual)
Study Completion Date
December 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tokat Gaziosmanpasa University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Disorders, Arthralgia of TMJ
Keywords
Auriculotemporal nerve block, Temporomandibular disorders, Physiotherapy, Anesthesia, Local

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Participants whose Temporomandibular disorders (TMD)-related complaints continued despite occlusal stabilization splint, NSAIDs and centrally acting muscle relaxant treatments were administered a total of 3 doses of Auriculotemporal Nerve Block (ATNB).
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Auriculotemporal Nerve Block Administration
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
local anaesthetic injection
Intervention Description
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 Outcome Measure Information:
Title
Baseline Pain Intensity
Description
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.
Time Frame
At the initial visit before starting anesthetic administration.
Title
Post-injection Pain Intensity
Description
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.
Time Frame
At six months follow-up visit
Title
Change From Baseline Maximal Mouth Opening on Post-Injection Follow Up Visits
Description
All patients' maximal mouth opening were measured and recorded as the distance between upper and lower right central incisors.
Time Frame
At the first week, fourth week and sixth month.
Secondary Outcome Measure Information:
Title
Overall Satisfaction With The Applied Treatment
Description
Patients were asked dichotomously to define the ATNB as successful/unsuccessful, according to their experience. The patients' responses were recorded individually.
Time Frame
At the six-month follow-up visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehmet K. Tümer, AssocProfDr
Organizational Affiliation
Alanya Alaaddin Keykubat University
Official's Role
Study Director
Facility Information:
Facility Name
Tokat Gaziosmanpasa University, Faculty of Dentistry
City
Tokat
ZIP/Postal Code
60100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The data regarding participants were made available in the manuscript
Citations:
Citation
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.
Results Reference
background
PubMed Identifier
17588187
Citation
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.
Results Reference
background
PubMed Identifier
23229236
Citation
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.
Results Reference
result

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Auriculotemporal Nerve Block in TMJ Disorders

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