Temporomandibular Joint DisordersNCT04827784
Auriculotemporal Nerve Block in TMJ Disorders
A study testing local anaesthetic injection in people with Temporomandibular Joint Disorders and Arthralgia of TMJ, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Temporomandibular Joint Disorders, Arthralgia of TMJ
- What is being tested?
- local anaesthetic injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2020to 7 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tokat Gaziosmanpasa University, Faculty of Dentistry
Tokat Province, 60100
About this study
Official title: 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.
Read the 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.
- Being tested
- local anaesthetic injection
- Keywords
- Auriculotemporal nerve block, Temporomandibular disorders, Physiotherapy, Anesthesia, Local
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
local anaesthetic injectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: local anaesthetic injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: At the first week, fourth week and sixth month.
Secondary outcomes (1)
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.
Measured: At the six-month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start15 Jan 2020
- Primary completion23 Sep 2020
- Study completion7 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Joint DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aras Erdil, Tokat Gaziosmanpasa University
- Investigators
- Mehmet K. Tümer, AssocProfDr, Study director, Alanya Alaaddin Keykubat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04827784
- Sponsor's protocol ID
- GaziosmanpasaU2
- Status last verified
- Mar 2021
- First submitted
- 27 Mar 2021
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data regarding participants were made available in the manuscript
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.
PubMed 17588187Nascimento 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.
PubMed 23229236
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation Of The Efficacy Of Auriculotemporal Nerve Block In Temporomandibular Disorders
- ClinicalTrials.gov ID
- NCT04827784
- Acronym / sponsor ID
- GaziosmanpasaU2
- Keywords
- Auriculotemporal nerve block, Temporomandibular disorders, Physiotherapy, Anesthesia, Local
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 23 Sep 2020 (actual)
- Study completion
- 7 Dec 2020 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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).
| Arm | Type | Receives |
|---|---|---|
| Auriculotemporal Nerve Block Administration | Experimental | Procedure: local anaesthetic injectionA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| local anaesthetic injectionThe 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. | Procedure or surgery | Auriculotemporal Nerve Block Administration |
Primary outcome
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.
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.
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.
1 secondary outcome
Overall Satisfaction With The Applied Treatment
Time frame: At the six-month follow-up visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- BackgroundNASCIMENTO, 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: PubMed 17588187Ayesh 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 publication: PubMed 23229236Nascimento 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.
- Individual participant dataSharing planned: No. The data regarding participants were made available in the manuscript
Related trials for Temporomandibular Joint Disorders
Recruiting
R01_Pilot Jaw Muscle Phenotypes
Chronic TMD Pain, Temporomandibular Disorder
Recruiting
Evaluation of the Effect of Adding Sodium Bicarbonate to Lidocaine in the Treatment of Myofascial Pain Syndrome
Myofacial Pain, Myofacial Pain Syndrome
Recruiting
Clinical and Electromyographic Assessment of Occlusal Splint Therapy
Temporomandibular Joint Disorders
Recruiting
An Open Label Study Assessing REN Treatment in Headache Management in Temporomandibular Disorders
Temporomandibular Disorder, Orofacial Pain
Recruiting
Machine Learning for Evaluating and Diagnosing Temporomandibular Disorders
Temporomandibular Disorders (TMD), TMJ Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehmet K. Tümer, AssocProfDr study director
Alanya Alaaddin Keykubat University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing local anaesthetic injection in people with Temporomandibular Joint Disorders and Arthralgia of TMJ, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline Pain Intensity (time frame: At the initial visit before starting anesthetic administration.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04827784, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.