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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04827784
Other study ID # GaziosmanpasaU2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 15, 2020
Est. completion date December 7, 2020

Study information

Verified date March 2021
Source Tokat Gaziosmanpasa University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date December 7, 2020
Est. primary completion date September 23, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
local anaesthetic injection
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.

Locations

Country Name City State
Turkey Tokat Gaziosmanpasa University, Faculty of Dentistry Tokat

Sponsors (1)

Lead Sponsor Collaborator
Tokat Gaziosmanpasa University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. Epub 2007 Feb 15. — View 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. — View 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.

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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
Primary 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 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. At the six-month follow-up visit
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