Temporomandibular Joint DisordersPhase 4NCT05817162
Temporomandibular Joint Arthrocentesis With Infiltration of PRP + Ropivacaine Versus PRP
A Phase 4 study testing Ropivacaine injection, temporomandibular joint arthrocentesis and PRP injection in people with Temporomandibular Joint Disorders, run by Instituto Portugues da Face at 1 site in Portugal.
Trial summary
The infiltration of Platelet Rich Plasma (PRP) at the end of Temporomandibular Joint (TMJ) arthrocentesis is already an established procedure in the treatment of Temporomandibular Disorders (TMD). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Temporomandibular Joint Disorders
- What is being tested?
- Ropivacaine injection, temporomandibular joint arthrocentesis and PRP injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Apr 2023to 1 Jul 2024
- Phase
- Phase 4
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects between the ages of 18-99 years;
- For women of reproductive potential: use of highly effective contraception for at least 1 month prior to the first visit and agreement to use such a method during participation in the study;
- In the opinion of the investigator, the subject is capable of understanding and comprehending the study in question;
- The subject signs the written informed consent form and provides the necessary privacy clearance prior to the start of any study procedures;
- Patients with TMD with an indication for TMJ arthrocentesis: clinical and imaging diagnosis of unilateral or bilateral intra-articular disorder;
- Magnetic resonance imaging (MRI) assessing the intra-articular derangement;
- Radiological findings that most components of the joint were salvageable;
- Dimitroulis classification between 2 and 3.
Who cannot join
- Subject has had other previous minimally invasive or invasive treatment for TMD;
- Subject has any contraindication to the use of ropivacaine according to the Ropivacaine (Fresenius Kabi) bulletin;
- Subject has a history of allergy to any drug in the study;
- Subject taking analgesic medication prior to treatment for other conditions;
- The subject has an inability to interpret pain scales or to read and interpret the study's target questionnaire;
- Women who are pregnant or breastfeeding. For women of reproductive potential, use of highly effective contraception for at least 1 month prior to the first visit is required (Combined oral contraceptive pill, vaginal ring, male and female condom, intrauterine device, diaphragm, injectable hormonal contraceptive) and agreement to use such a method during study participation.
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- Subjects under 18 and over 99 years old;
- Subjects diagnosed with the following conditions cannot participate in the study: cardiovascular disorders, peripheral vascular disease, arrhythmias, auriculoventricular conduction disorders, heart failure; hypotension, epileptic patients, patients with liver and kidney disease, patients with porphyria, patients with acidosis.
- Subjects with severe medical problems and mental illness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Temporomandibular Joint Arthrocentesis With Infiltration of PRP + Ropivacaine Versus PRP: Does It Reduce Postoperative Pain?
The infiltration of Platelet Rich Plasma (PRP) at the end of Temporomandibular Joint (TMJ) arthrocentesis is already an established procedure in the treatment of Temporomandibular Disorders (TMD). Arthrocentesis is a minimally invasive surgical procedure, which aims to eliminate the inflammatory mediators from the inside of the TMJ. PRP is an autologous concentrate of platelets and growth factors, derived from centrifugated blood. Several studies have described the benefits of PRP: it enhances wound healing because of the presence of cytokines and growth factors, and is also stimulates chondrocytes to biosynthesis of collagen. Ropivacaine is a local anesthetic that has been synthesized for use in infiltration anesthesia and to produce both peripheral and central block. Unlike one of its analogues, Bupivacaine, Ropivacaine anesthetize the sensory fibers without affecting the motor ones. The main goal of this investigation is to test the benefits of adding Ropivacaine to the infiltration of PRP in patients submitted to TMJ arthrocentesis.
Read the detailed description
To investigate the potential reduction of pain in the postoperative week in patients submitted to temporomandibular joint double portal arthrocentesis with lavage and Platelet Rich Plasma (PRP) the authors designed a double-blind randomized clinical trial, comparing a treatment group with additional ropivacaine and a control group without ropivacaine.
- Conditions
- Temporomandibular Joint Disorders
- Being tested
- Ropivacaine injection, temporomandibular joint arthrocentesis, PRP injection, Ringer's Lactate solution
- Keywords
- temporomandibular disorders, temporomandibular joint arthrocentesis, ropivacaine, randomized clinical trial
- 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.
Ropivacaine injectionDrug
Ropivacaine is a local anesthetic that has been synthesized for use in infiltration anesthesia and to produce both peripheral and central block. Unlike one of its analogues, Bupivacaine, Ropivacaine anesthetize the sensory fibers without affecting the without affecting the motor ones. Ropivacaine comes as solution for injection.
temporomandibular joint arthrocentesisProcedure or surgery
Temporomandibular arthrocentesis is a minimally invasive surgical procedure, which aims to eliminate the inflammatory mediators from the inside of the TMJ.
PRP injectionDrug
Platelet-Rich Plasma (PRP) is an orthobiological adjuvant treatment. PRP has properties to restore intra-articular hyaluronic acid, increases glycosaminoglycan chondrocyte synthesis and balances joint angiogenesis. It is often used as a viscosupplement in TMJ arthrocentesis
Ringer's Lactate solutionDrug
Ringers lactate solution is used during arthrocentesis to wash out the joint inflammatory cells and to release the stuck disc phenomenon.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group: PRP | Placebo comparator | Temporomandibular joint arthrocentesis, Ringer lactate for washing, and 1ml PRP infiltration in each temporomandibular joint Receives: Procedure: temporomandibular joint arthrocentesis; Drug: PRP injection; Drug: Ringer's Lactate solution |
| PRP + Ropivacaine | Active comparator | Temporomandibular joint arthrocentesis, Ringer lactate for washing, and 1ml PRP + ropivacaine infiltration in each temporomandibular joint Receives: Drug: Ropivacaine injection; Procedure: temporomandibular joint arthrocentesis; Drug: PRP injection; Drug: Ringer's Lactate solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
TMJ Pain
Change in TMJ pain in a 0-10 scale (where 0 is no pain and 10 is the maximum possible pain) assessed by the surgeon
Measured: In the first week at a consultation after injection and TMJ arthrocentesis
Secondary outcomes (16)
Postoperative pain
Change in TMJ pain / TMJ muscles pain: measured by the patient using a Visual Analogue scale (VAS), with a range from 0 to 10, with 0 being no pain and 10 having maximum unbearable pain. VAS score will be measured every day before TMJ arthrocentesis in the week after surgery.
Measured: Daily 1 week after TMJ arthrocentesis and infiltration
General state pre vs post
Daily questionnaire based (OHIP 10) furnished by surgeon to fill at home: the patient has to fill it every day for 1 week. (0-much better, 1-litte better, 2-no changes, 3-litter worse, 4-much worse)
Measured: Daily 1 week after TMJ arthrocentesis and infiltration
Functional limitation chewing foods
Daily questionnaire based (OHIP 10) furnished by surgeon to fill at home: the patient has to fill it every day for 1 week (0-never, 1-hardly never, 2-occasionally, 3-fairy often, 4-very often)
Measured: Daily 1 week after TMJ arthrocentesis and infiltration
Difficulty closing and mouth opening
Daily questionnaire based (OHIP 10) furnished by surgeon to fill at home: the patient has to fill it every day for 1 week (0-never, 1-hardly never, 2-occasionally, 3-fairy often, 4-very often)
Measured: Daily 1 week after TMJ arthrocentesis and infiltration
TMJ pain, muscular pain, ear pain
Daily questionnaire based (OHIP 10) furnished by surgeon to fill at home: the patient has to fill it every day for 1 week (0-never, 1-hardly never, 2-occasionally, 3-fairy often, 4-very often)
Measured: Daily 1 week after TMJ arthrocentesis and infiltration
Interrupt meals
Daily questionnaire based (OHIP 10) furnished by surgeon to fill at home: the patient has to fill it every day for 1 week (0-never, 1-hardly never, 2-occasionally, 3-fairy often, 4-very often)
Measured: Daily 1 week after TMJ arthrocentesis and infiltration
Sleep been interrupted
Daily questionnaire based (OHIP 10) furnished by surgeon to fill at home: the patient has to fill it every day for 1 week (0-never, 1-hardly never, 2-occasionally, 3-fairy often, 4-very often)
Measured: Daily 1 week after TMJ arthrocentesis and infiltration
Difficult doing usual jobs
Daily questionnaire based (OHIP 10) furnished by surgeon to fill at home: the patient has to fill it every day for 1 week (0-never, 1-hardly never, 2-occasionally, 3-fairy often, 4-very often)
Measured: Daily 1 week after TMJ arthrocentesis and infiltration
Unable to work full capacity
Daily questionnaire based (OHIP 10) furnished by surgeon to fill at home: the patient has to fill it every day for 1 week (0-never, 1-hardly never, 2-occasionally, 3-fairy often, 4-very often)
Measured: Daily 1 week after TMJ arthrocentesis and infiltration
Difficult to relax
Daily questionnaire based (OHIP 10) furnished by surgeon to fill at home: the patient has to fill it every day for 1 week (0-never, 1-hardly never, 2-occasionally, 3-fairy often, 4-very often)
Measured: Daily 1 week after TMJ arthrocentesis and infiltration
Need of medication after intervention
Indication of the number of SOS analgesic pills taken each day
Measured: Daily 1 week after TMJ arthrocentesis and infiltration
TMJ pain assessed by the physiotherapist
Pain in left and right TMJ evaluated by the physiotherapist in a 0-10 scale (where 0 is no pain and 10 is the maximum possible pain)
Measured: 1 week after injection and TMJ arthrocentesis in a physiotherapy consultation
TMJ pain during lateral deviation assessed by the physiotherapist
Pain in left and right TMJ during lateral deviation evaluated by the physiotherapist in a 0-10 scale (where 0 is no pain and 10 is the maximum possible pain)
Measured: 1 week after injection and TMJ arthrocentesis in a physiotherapy consultation
TMJ pain during protrusion assessed by the physiotherapist
TMJ pain during protrusion evaluated by the physiotherapist in a 0-10 scale (where 0 is no pain and 10 is the maximum possible pain)
Measured: 1 week after injection and TMJ arthrocentesis in a physiotherapy consultation
Myalgia degree assessed by the physiotherapist
Myalgia degree in right and left masseter and temporalis muscles evaluated by the physiotherapist in a 0-3 scale
Measured: 1 week after injection and TMJ arthrocentesis in a physiotherapy consultation
Physiotherapist's perception of comfort during the consultation
For the therapist: in a 0 to 10 scale evaluate your perception of patients comfort during the physical therapy question
Measured: 1 week after injection and TMJ arthrocentesis in a physiotherapy consultation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start1 Apr 2023
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- For this randomized clinical trial an appropriate number of sealed envelopes will be prepared: 15 for PRP and 15 for PRP + Ropivacaine. Patients with inclusion criteria will be seen in an orofacial pain session and assessed for pain using the VAS scale, by scoring the degree of pain between 0 (absence of pain) and 10 (maximum pain). Then the patients are proposed for TMJ arthrocentesis.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Portugues da Face
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817162
- Sponsor's protocol ID
- ROPIVACAINE_TMJ
- Status last verified
- Mar 2023
- First submitted
- 4 Apr 2023
- Last updated
- 20 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to data protection policy it is not possible to share this data with other researchers.
Publications
Derwich M, Mitus-Kenig M, Pawlowska E. Mechanisms of Action and Efficacy of Hyaluronic Acid, Corticosteroids and Platelet-Rich Plasma in the Treatment of Temporomandibular Joint Osteoarthritis-A Systematic Review. Int J Mol Sci. 2021 Jul 9;22(14):7405. doi: 10.3390/ijms22147405.
PubMed 34299024Keyser C, Bhashyam A, Abdurrob A, Smith JT, Bluman E, Chiodo C. Excess Opioid Disposal Following Orthopaedic Surgery: A Randomized Clinical Trial. Foot Ankle Spec. 2022 Dec;15(6):545-550. doi: 10.1177/1938640020980921. Epub 2020 Dec 27.
PubMed 33356547Rao TN, Goswami D, Roychoudhury A, Bhutia O, Baidya DK, Trikha A. Efficacy of Local Anesthetic Wound Infiltration in Temporomandibular Joint Ankylosis Surgery for Control of Postoperative Pain: A Prospective, Randomized Controlled, and Double-Blinded Trial. J Oral Maxillofac Surg. 2021 Mar;79(3):559.e1-559.e11. doi: 10.1016/j.joms.2020.10.034. Epub 2020 Oct 29.
PubMed 33232658
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Temporomandibular Joint Arthrocentesis With Infiltration of PRP + Ropivacaine Versus PRP: Does It Reduce Postoperative Pain?
- ClinicalTrials.gov ID
- NCT05817162
- Acronym / sponsor ID
- ROPIVACAINE_TMJ
- Conditions
- Temporomandibular Joint Disorders
- Keywords
- temporomandibular disorders, temporomandibular joint arthrocentesis, ropivacaine, randomized clinical trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Instituto Portugues da FaceUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 18 Apr 2023 (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 infiltration of Platelet Rich Plasma (PRP) at the end of Temporomandibular Joint (TMJ) arthrocentesis is already an established procedure in the treatment of Temporomandibular Disorders (TMD). Arthrocentesis is a minimally invasive surgical procedure, which aims to eliminate the inflammatory mediators from the inside of the TMJ. PRP is an autologous concentrate of platelets and growth factors, derived from centrifugated blood. Several studies have described the benefits of PRP: it enhances wound healing because of the presence of cytokines and growth factors, and is also stimulates chondrocytes to biosynthesis of collagen. Ropivacaine is a local anesthetic that has been synthesized for use in infiltration anesthesia and to produce both peripheral and central block. Unlike one of its analogues, Bupivacaine, Ropivacaine anesthetize the sensory fibers without affecting the motor ones. The main goal of this investigation is to test the benefits of adding Ropivacaine to the infiltration of PRP in patients submitted to TMJ arthrocentesis.
Detailed description
To investigate the potential reduction of pain in the postoperative week in patients submitted to temporomandibular joint double portal arthrocentesis with lavage and Platelet Rich Plasma (PRP) the authors designed a double-blind randomized clinical trial, comparing a treatment group with additional ropivacaine and a control group without ropivacaine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- For this randomized clinical trial an appropriate number of sealed envelopes will be prepared: 15 for PRP and 15 for PRP + Ropivacaine. Patients with inclusion criteria will be seen in an orofacial pain session and assessed for pain using the VAS scale, by scoring the degree of pain between 0 (absence of pain) and 10 (maximum pain). Then the patients are proposed for TMJ arthrocentesis.
| Arm | Type | Receives |
|---|---|---|
| Placebo Group: PRP | Placebo comparator | Procedure: temporomandibular joint arthrocentesis, Drug: PRP injection, Drug: Ringer's Lactate solutionTemporomandibular joint arthrocentesis, Ringer lactate for washing, and 1ml PRP infiltration in each temporomandibular joint |
| PRP + Ropivacaine | Active comparator | Drug: Ropivacaine injection, Procedure: temporomandibular joint arthrocentesis, Drug: PRP injection, Drug: Ringer's Lactate solutionTemporomandibular joint arthrocentesis, Ringer lactate for washing, and 1ml PRP + ropivacaine infiltration in each temporomandibular joint |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and female subjects between the ages of 18-99 years;
- For women of reproductive potential: use of highly effective contraception for at least 1 month prior to the first visit and agreement to use such a method during participation in the study;
- In the opinion of the investigator, the subject is capable of understanding and comprehending the study in question;
- The subject signs the written informed consent form and provides the necessary privacy clearance prior to the start of any study procedures;
- Patients with TMD with an indication for TMJ arthrocentesis: clinical and imaging diagnosis of unilateral or bilateral intra-articular disorder;
Key exclusion criteria (9 listed)
- Subject has had other previous minimally invasive or invasive treatment for TMD;
- Subject has any contraindication to the use of ropivacaine according to the Ropivacaine (Fresenius Kabi) bulletin;
- Subject has a history of allergy to any drug in the study;
- Subject taking analgesic medication prior to treatment for other conditions;
- The subject has an inability to interpret pain scales or to read and interpret the study's target questionnaire;
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 |
|---|---|---|
| Ropivacaine injectionRopivacaine is a local anesthetic that has been synthesized for use in infiltration anesthesia and to produce both peripheral and central block. Unlike one of its analogues, Bupivacaine, Ropivacaine anesthetize the sensory fibers without affecting the without affecting the motor ones. Ropivacaine comes as solution for injection. | Drug | PRP + Ropivacaine |
| temporomandibular joint arthrocentesisTemporomandibular arthrocentesis is a minimally invasive surgical procedure, which aims to eliminate the inflammatory mediators from the inside of the TMJ. | Procedure or surgery | PRP + Ropivacaine, Placebo Group: PRP |
| PRP injectionPlatelet-Rich Plasma (PRP) is an orthobiological adjuvant treatment. PRP has properties to restore intra-articular hyaluronic acid, increases glycosaminoglycan chondrocyte synthesis and balances joint angiogenesis. It is often used as a viscosupplement in TMJ arthrocentesis | Drug | PRP + Ropivacaine, Placebo Group: PRP |
| Ringer's Lactate solutionRingers lactate solution is used during arthrocentesis to wash out the joint inflammatory cells and to release the stuck disc phenomenon. | Drug | PRP + Ropivacaine, Placebo Group: PRP |
Primary outcome
TMJ Pain
Time frame: In the first week at a consultation after injection and TMJ arthrocentesis
Change in TMJ pain in a 0-10 scale (where 0 is no pain and 10 is the maximum possible pain) assessed by the surgeon
16 secondary outcomes
Postoperative pain
Time frame: Daily 1 week after TMJ arthrocentesis and infiltration
General state pre vs post
Time frame: Daily 1 week after TMJ arthrocentesis and infiltration
Functional limitation chewing foods
Time frame: Daily 1 week after TMJ arthrocentesis and infiltration
Difficulty closing and mouth opening
Time frame: Daily 1 week after TMJ arthrocentesis and infiltration
TMJ pain, muscular pain, ear pain
Time frame: Daily 1 week after TMJ arthrocentesis and infiltration
Interrupt meals
Time frame: Daily 1 week after TMJ arthrocentesis and infiltration
Sleep been interrupted
Time frame: Daily 1 week after TMJ arthrocentesis and infiltration
Difficult doing usual jobs
Time frame: Daily 1 week after TMJ arthrocentesis and infiltration
Unable to work full capacity
Time frame: Daily 1 week after TMJ arthrocentesis and infiltration
Difficult to relax
Time frame: Daily 1 week after TMJ arthrocentesis and infiltration
Need of medication after intervention
Time frame: Daily 1 week after TMJ arthrocentesis and infiltration
TMJ pain assessed by the physiotherapist
Time frame: 1 week after injection and TMJ arthrocentesis in a physiotherapy consultation
TMJ pain during lateral deviation assessed by the physiotherapist
Time frame: 1 week after injection and TMJ arthrocentesis in a physiotherapy consultation
TMJ pain during protrusion assessed by the physiotherapist
Time frame: 1 week after injection and TMJ arthrocentesis in a physiotherapy consultation
Myalgia degree assessed by the physiotherapist
Time frame: 1 week after injection and TMJ arthrocentesis in a physiotherapy consultation
Physiotherapist's perception of comfort during the consultation
Time frame: 1 week after injection and TMJ arthrocentesis in a physiotherapy consultation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
- Background: PubMed 34299024Derwich M, Mitus-Kenig M, Pawlowska E. Mechanisms of Action and Efficacy of Hyaluronic Acid, Corticosteroids and Platelet-Rich Plasma in the Treatment of Temporomandibular Joint Osteoarthritis-A Systematic Review. Int J Mol Sci. 2021 Jul 9;22(14):7405. doi: 10.3390/ijms22147405.
- Background: PubMed 33356547Keyser C, Bhashyam A, Abdurrob A, Smith JT, Bluman E, Chiodo C. Excess Opioid Disposal Following Orthopaedic Surgery: A Randomized Clinical Trial. Foot Ankle Spec. 2022 Dec;15(6):545-550. doi: 10.1177/1938640020980921. Epub 2020 Dec 27.
- Background: PubMed 33232658Rao TN, Goswami D, Roychoudhury A, Bhutia O, Baidya DK, Trikha A. Efficacy of Local Anesthetic Wound Infiltration in Temporomandibular Joint Ankylosis Surgery for Control of Postoperative Pain: A Prospective, Randomized Controlled, and Double-Blinded Trial. J Oral Maxillofac Surg. 2021 Mar;79(3):559.e1-559.e11. doi: 10.1016/j.joms.2020.10.034. Epub 2020 Oct 29.
- Individual participant dataSharing planned: No. Due to data protection policy it is not possible to share this data with other researchers.
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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 Phase 4 study testing Ropivacaine injection, temporomandibular joint arthrocentesis and PRP injection in people with Temporomandibular Joint Disorders, run by Instituto Portugues da Face at 1 site in Portugal.
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 8 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 20 Apr 2023. 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 Portugal. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
TMJ Pain (time frame: In the first week at a consultation after injection and TMJ arthrocentesis). 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 NCT05817162, 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 20 Apr 2023.