Temporomandibular Joint Disc DisplacementNCT06256042
Effectiveness of Arthrocentesis and the Occlusal Splint in Treatment of the TMJ
A study testing Occlusal splint and Arthrocentesis in people with Temporomandibular Joint Disc Displacement and Anterior Disc Displacement, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The goal of this clinical trial is to compare occlusal splint and arthrocentesis in patients with disc displacement with/without reduction. The main question it aims to answer are: Is there a more effective treatment for this cases? Participants will answer a questionary about pain and functional limitations. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Joint Disc Displacement, Anterior Disc Displacement
- What is being tested?
- Occlusal splint and Arthrocentesis
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- 30 May 2021to 15 Jan 2024
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients at least 18 years old;
- Diagnosed with disc displacement with reduction with intermittent block or disc displacement without reduction;
- Availability of clinical follow-up for 6 months.
Who cannot join
- Pregnant patients;
- Patients undergoing conservative or invasive interventions to treat TMD in the last 6 months;
- Inability to use a stabilizing occlusal splint;
- Presence of toothache, neoplasms or medical contraindication for study participation.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University of São Paulo Faculty of Medicine Clinics Hospital
São Paulo, 05.403-905
About this study
Official title: Effectiveness of Arthrocentesis and the Occlusal Splint in Treatment of Disc Displacements of the Temporomandibular Joint
The goal of this clinical trial is to compare occlusal splint and arthrocentesis in patients with disc displacement with/without reduction. The main question it aims to answer are:
- Is there a more effective treatment for this cases?
Participants will answer a questionary about pain and functional limitations.
Researchers will compare Group 1(occlusal plate) and Gruoup 2 (arthrocentesis) to see if there is pain reduction and functional improvement in patients with disc displacement with/without reduction
Read the detailed description
Introduction: Temporomandibular joint disc displacement is a disorder in which the articular disc is anteriorly displaced from its correct position in relation to the mandibular condyle and mandibular fossa. Traditionally, the initial treatment of disc displacements involves several conservative measures, among them, the stabilizing interocclusal splint. However, in cases where there is associated opening limitation, such as intermittent lock and closed-lock, arthrocentesis has been suggested as another initial treatment modality due to its faster effect in preventing disease progression to a more advanced stage, in addition to reducing the chances of pain chronicity and central sensitization. Objectives: The present study aimed to compare and analyze the effectiveness and benefits of performing arthrocentesis as the initial treatment in patients with DDWR with intermittent lock and in patients with DDWoR, compared to the stabilizing interocclusal splint. Additionally, it had as secondary objectives to characterize the sample according to demographic, systemic, local and psychosocial factors in both groups and to correlate the clinical characteristics of the included patients with the imaging findings of the MRI scans. Methods: A randomized, prospective, longitudinal pilot study was performed. The sample was obtained by convenience from a demand through consultations and referral, among patients treated at the Oral and Maxillofacial Surgery Service of HCFMUSP, from June 2021 to July 2023. Patients with diagnoses of: DDWR intermittent lock and DDWoR with opening mouth limitation. Study patients underwent an initial assessment using a clinical questionnaire (DC/TMD) and underwent an initial TMJ MRI. Then, they were randomly divided into two groups according to the treatment to which they would be submitted: stabilizing inter-occlusal splint (group 1) or arthrocentesis (group 2). After treatment was instituted, patients were evaluated at 1, 2, 3 and 6 months regarding clinical parameters of pain, functionality and psychosocial status.
- Being tested
- Occlusal splint, Arthrocentesis
- Keywords
- Temporomandibular joint, Anterior disc displacement, Arthrocentesis, Interocclusal stabilizing splint.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occlusal splintProcedure or surgery
a stabilizing maxillary acrylic occlusal splint was made, flat, total and adjusted in central relation (RC).
ArthrocentesisProcedure or surgery
The patient then underwent arthrocentesis of the temporomandibular joint itself, following the Nitzan technique.
| Study group | Role | What they receive |
|---|---|---|
| Arthrocentesis | Active comparator | Delimitation of a corner-tragus line to mark points A (10mm in front of the tragus and 2mm below the CT line) and B (20mm in front of the tragus and 10mm below the CT line); Local intra- and extra-oral antisepsis with aqueous chlorhexidine 0.12% and 0.2%, respectively; Local anesthesia of the auriculotemporal and intra-capsular nerve with mepivacaine 2% + Epinephrine 1:100,000; Insertion of the first 30x0.8 mm needle at point A and injection of 2-3 mL of Lactated Ringer; Insert the second 30x0.8 mm needle into point B Wash with 100-200mL of Ringer Lactate; Removal of the second needle; Injection of 1mL of 20mg Triamcinolone diluted in 0.9% saline solution (1:1) through the needle at point A. Receives: Procedure: Arthrocentesis |
| Occlusal splint | Active comparator | A stabilizing maxillary acrylic occlusal splint was made, flat, total and adjusted in central relation (RC). Receives: Procedure: Occlusal splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Jaw function available in mouth opening and moviments of jaw
millimeter scale
Measured: 6 months
Secondary outcomes (1)
Pain available through of Visual Analogue Scale
the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-10. It's been 0 (without pain) and 10 (worst pain)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start30 May 2021
- Primary completion28 Feb 2022
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint Disc DisplacementStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Stabilizing interocclusal plate (IOP): a stabilizing maxillary acrylic occlusal plate was made, flat, total and adjusted in central relation (RC). Advice and guidance on the disease. Arthrocentesis: Delimitation of a corner-tragus line to mark points A (10mm in front of the tragus and 2mm below the CT line) and B (20mm in front of the tragus and 10mm below the CT line); Local intra- and extra-oral antisepsis with aqueous chlorhexidine 0.12% and 0.2%, respectively; Local anesthesia of the auriculotemporal and intra-capsular nerve with mepivacaine 2% + Epinephrine 1:100,000; Insertion of the first 30x0.8 mm needle at point A and injection of 2-3 mL of Lactated Ringer; Insert the second 30x0.8 mm needle into point B Wash with 100-200mL of Ringer Lactate; Removal of the second needle; Injection of 1mL of 20mg Triamcinolone diluted in 0.9% saline solution (1:1) through the needle at point A.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gustavo Grothe Machado, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06256042
- Sponsor's protocol ID
- 50207321.8.0000.0068
- Status last verified
- Feb 2024
- First submitted
- 23 Jan 2024
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Arthrocentesis and the Occlusal Splint in Treatment of Disc Displacements of the Temporomandibular Joint
- ClinicalTrials.gov ID
- NCT06256042
- Acronym / sponsor ID
- 50207321.8.0000.0068
- Keywords
- Temporomandibular joint, Anterior disc displacement, Arthrocentesis, Interocclusal stabilizing splint.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 30 May 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 13 Feb 2024 (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 goal of this clinical trial is to compare occlusal splint and arthrocentesis in patients with disc displacement with/without reduction. The main question it aims to answer are:
- Is there a more effective treatment for this cases?
Participants will answer a questionary about pain and functional limitations.
Researchers will compare Group 1(occlusal plate) and Gruoup 2 (arthrocentesis) to see if there is pain reduction and functional improvement in patients with disc displacement with/without reduction
Detailed description
Introduction: Temporomandibular joint disc displacement is a disorder in which the articular disc is anteriorly displaced from its correct position in relation to the mandibular condyle and mandibular fossa. Traditionally, the initial treatment of disc displacements involves several conservative measures, among them, the stabilizing interocclusal splint. However, in cases where there is associated opening limitation, such as intermittent lock and closed-lock, arthrocentesis has been suggested as another initial treatment modality due to its faster effect in preventing disease progression to a more advanced stage, in addition to reducing the chances of pain chronicity and central sensitization. Objectives: The present study aimed to compare and analyze the effectiveness and benefits of performing arthrocentesis as the initial treatment in patients with DDWR with intermittent lock and in patients with DDWoR, compared to the stabilizing interocclusal splint. Additionally, it had as secondary objectives to characterize the sample according to demographic, systemic, local and psychosocial factors in both groups and to correlate the clinical characteristics of the included patients with the imaging findings of the MRI scans. Methods: A randomized, prospective, longitudinal pilot study was performed. The sample was obtained by convenience from a demand through consultations and referral, among patients treated at the Oral and Maxillofacial Surgery Service of HCFMUSP, from June 2021 to July 2023. Patients with diagnoses of: DDWR intermittent lock and DDWoR with opening mouth limitation. Study patients underwent an initial assessment using a clinical questionnaire (DC/TMD) and underwent an initial TMJ MRI. Then, they were randomly divided into two groups according to the treatment to which they would be submitted: stabilizing inter-occlusal splint (group 1) or arthrocentesis (group 2). After treatment was instituted, patients were evaluated at 1, 2, 3 and 6 months regarding clinical parameters of pain, functionality and psychosocial status.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stabilizing interocclusal plate (IOP): a stabilizing maxillary acrylic occlusal plate was made, flat, total and adjusted in central relation (RC). Advice and guidance on the disease. Arthrocentesis: Delimitation of a corner-tragus line to mark points A (10mm in front of the tragus and 2mm below the CT line) and B (20mm in front of the tragus and 10mm below the CT line); Local intra- and extra-oral antisepsis with aqueous chlorhexidine 0.12% and 0.2%, respectively; Local anesthesia of the auriculotemporal and intra-capsular nerve with mepivacaine 2% + Epinephrine 1:100,000; Insertion of the first 30x0.8 mm needle at point A and injection of 2-3 mL of Lactated Ringer; Insert the second 30x0.8 mm needle into point B Wash with 100-200mL of Ringer Lactate; Removal of the second needle; Injection of 1mL of 20mg Triamcinolone diluted in 0.9% saline solution (1:1) through the needle at point A.
| Arm | Type | Receives |
|---|---|---|
| Arthrocentesis | Active comparator | Procedure: ArthrocentesisDelimitation of a corner-tragus line to mark points A (10mm in front of the tragus and 2mm below the CT line) and B (20mm in front of the tragus and 10mm below the CT line); Local intra- and extra-oral antisepsis with aqueous chlorhexidine 0.12% and 0.2%, respectively; Local anesthesia of the auriculotemporal and intra-capsular nerve with mepivacaine 2% + Epinephrine 1:100,000; Insertion of the first 30x0.8 mm needle at point A and injection of 2-3 mL of Lactated Ringer; Insert the second 30x0.8 mm needle into point B Wash with 100-200mL of Ringer Lactate; Removal of the second needle; Injection of 1mL of 20mg Triamcinolone diluted in 0.9% saline solution (1:1) through the needle at point A. |
| Occlusal splint | Active comparator | Procedure: Occlusal splintA stabilizing maxillary acrylic occlusal splint was made, flat, total and adjusted in central relation (RC). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients at least 18 years old;
- Diagnosed with disc displacement with reduction with intermittent block or disc displacement without reduction;
- Availability of clinical follow-up for 6 months.
Key exclusion criteria (4 listed)
- Pregnant patients;
- Patients undergoing conservative or invasive interventions to treat TMD in the last 6 months;
- Inability to use a stabilizing occlusal splint;
- Presence of toothache, neoplasms or medical contraindication for study participation.
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 |
|---|---|---|
| Occlusal splinta stabilizing maxillary acrylic occlusal splint was made, flat, total and adjusted in central relation (RC). | Procedure or surgery | Occlusal splint |
| ArthrocentesisThe patient then underwent arthrocentesis of the temporomandibular joint itself, following the Nitzan technique. | Procedure or surgery | Arthrocentesis |
Primary outcome
Jaw function available in mouth opening and moviments of jaw
Time frame: 6 months
millimeter scale
1 secondary outcome
Pain available through of Visual Analogue Scale
Time frame: 6 months
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 13 Feb 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occlusal splint and Arthrocentesis in people with Temporomandibular Joint Disc Displacement and Anterior Disc Displacement, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 3 inclusion and 4 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 13 Feb 2024. 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 Brazil. 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?
Jaw function available in mouth opening and moviments of jaw (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2024.