NCT04827784

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

8 months

First QC Date

March 27, 2021

Last Update Submit

March 30, 2021

Conditions

Keywords

Auriculotemporal nerve blockTemporomandibular disordersPhysiotherapyAnesthesiaLocal

Outcome Measures

Primary Outcomes (3)

  • 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.

    At the initial visit before starting anesthetic administration.

  • 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.

    At six months follow-up visit

  • 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.

    At the first week, fourth week and sixth month.

Secondary Outcomes (1)

  • Overall Satisfaction With The Applied Treatment

    At the six-month follow-up visit

Study Arms (1)

Auriculotemporal Nerve Block Administration

EXPERIMENTAL

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.

Procedure: local anaesthetic injection

Interventions

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.

Auriculotemporal Nerve Block Administration

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tokat Gaziosmanpasa University, Faculty of Dentistry

Tokat Province, 60100, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    BACKGROUND
  • 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.

    PMID: 17588187BACKGROUND
  • 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.

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Anesthesia, Local

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • Mehmet K. Tümer, AssocProfDr

    Alanya Alaaddin Keykubat University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Oral and Maxillofacial Surgeon

Study Record Dates

First Submitted

March 27, 2021

First Posted

April 1, 2021

Study Start

January 15, 2020

Primary Completion

September 23, 2020

Study Completion

December 7, 2020

Last Updated

April 1, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

The data regarding participants were made available in the manuscript

Locations