Temporomandibular Joint DisordersNCT06457698
Temporomandibular Bioviscosuplementation (Platelet-Rich Plasma Combined With Hyaluronic Acid) After Double-Puncture Arthrocentesis: a Randomized Controlled Trial
A study testing Double-puncture TMJ arthrocentesis under local anaesthesia in people with Temporomandibular Joint Disorders, run by Instituto Portugues da Face at 1 site in Portugal.
Trial summary
Intra-articular injections of hyaluronic acid (HA) or platelet-rich plasma (PRP) have been used with temporomandibular joint (TMJ) arthrocentesis to improve lubricative properties and influence regenerative processes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Temporomandibular Joint Disorders
- What is being tested?
- Double-puncture TMJ arthrocentesis under local anaesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Jun 2022to 1 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) age >18 years; (2) history of conservative treatment for TMD without significant improvement for at least three months; (3) clinical diagnosis of unilateral or bilateral intra-articular disorder; (3) clinical criteria for unilateral or bilateral TMJ arthrocentesis; (4) magnetic resonance imaging (MRI) and computed tomography (CT) documenting arthrogenous derangement.
Who cannot join
- The exclusion criteria included: 1) any history of previous TMJ surgical intervention or any facial trauma within the last 4 weeks before the study; 2) concomitant other contralateral TMJ surgery; 3) severe medical problems or mental illness and pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Intra-articular injections of hyaluronic acid (HA) or platelet-rich plasma (PRP) have been used with temporomandibular joint (TMJ) arthrocentesis to improve lubricative properties and influence regenerative processes. A randomized, controlled clinical trial investigated the benefits of complementary bioviscosuplementation (HA+PRP) in patients submitted to double-portal TMJ arthrocentesis.
- Conditions
- Temporomandibular Joint Disorders
- Being tested
- Double-puncture TMJ arthrocentesis under local anaesthesia
- Keywords
- Hyaluronic acid, platelet-rich plasma, arthrocentesis, viscosuplementation
- 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.
Double-puncture TMJ arthrocentesis under local anaesthesiaProcedure or surgery
The first puncture involved carefully palpating the lateral rim of the glenoid fossa. A 5-cc syringe was prepared with a mixture of 3 cc of Ringer lactate and 1.8 cc of lidocaine with epinephrine. A 21-G needle connected to the syringe was gently inserted into the TMJ skin area. Once the needle tip made contact with the posterior slope of the eminence of the upper joint compartment, it was oriented vertically to access the upper compartment, allowing the surgeon to perform a validation step. For the second puncture, the joint was maintained at maximum distention with continuous inflow through the first portal, while the surgeon felt insufflation/distention in the anterior joint area. The second portal was established using a 21-G needle with successful fluid outflow. After completing an effective circuit, joint washing was carried out using intra-articular hydraulic pressure with at least 150 ml of Ringer lactate solution.
| Study group | Role | What they receive |
|---|---|---|
| HA injection | Placebo comparator | After TMJ double-puncture arthrocenthesis under local anesthesia, hyaluronic acid (Suplasyn®, 20 mg/ml) will be injected in the joint with the first portal. Receives: Procedure: Double-puncture TMJ arthrocentesis under local anaesthesia |
| HA + PRP injection | Active comparator | 32ml of venous blood per joint will be collected and added to four 8ml-collection tubes containing sodium citrate. Then, blood will be centrifugated at 800rpm for 8 minutes at room temperature. 3 layers are perceptible: (1)layer with platelet-rich plasma and growth factors; (2)layer with white blood cells; (3)layer corresponding to red blood cells. Then, the total plasma volume will be calculated, and the plasma corresponding to the first fraction (low platelet fraction) aspirated. The second fraction of the first layer corresponding to PRP, above the white blood cell layer, will be removed and transferred to new tubes.
10 minutes before the mixing with HA, a calcium chloride-rich activator (Endoret ®, BTI Biotechnology Institute, Vitoria-Gasteiz, Álava, Spain) will be added to the PRP. The mixture of PRP with HA was then carried out at a ratio of 1cc of low molecular weight HA (Suplasyn®, 20 mg/ml) +1cc of PRP and introduced in the joint with the first portal. Receives: Procedure: Double-puncture TMJ arthrocentesis under local anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
TMJ arthralgia (VAS, 0-10)
The level of TMJ arthralgia was registered through pain during palpation of the lateral pole or around the lateral pole or pain on maximum unassisted or assisted opening, right or left lateral movements, or protrusive movements, following the DC/TMD guidelines.12, 13 Patient scored for each side using a 10-point VAS, from 0-no pain and 10-severe pain.
Measured: TMJ arthralgia will be assessed preoperatively (T0) and postoperatively (T1 - 1 month, T2 - 3 months, T3 - 6 months, T4 - 12 months follow-up).
Secondary outcomes (1)
maximum mouth opening (MMO)
MMO was measured using a certified ruler between the incisor's teeth.
Measured: MMO will be assessed preoperatively (T0) and postoperatively (T1 - 1 month, T2 - 3 months, T3 - 6 months, T4 - 12 months follow-up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Jun 2022
- Primary completion1 Jun 2024
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
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
- NCT06457698
- Sponsor's protocol ID
- SUPERPRP
- Status last verified
- Jun 2024
- First submitted
- 9 Jun 2024
- Last updated
- 13 Jun 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 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporomandibular Bioviscosuplementation (Platelet-Rich Plasma Combined With Hyaluronic Acid) After Double-Puncture Arthrocentesis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06457698
- Acronym / sponsor ID
- SUPERPRP
- Conditions
- Temporomandibular Joint Disorders
- Keywords
- Hyaluronic acid, platelet-rich plasma, arthrocentesis, viscosuplementation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Instituto Portugues da FaceUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 13 Jun 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.
Intra-articular injections of hyaluronic acid (HA) or platelet-rich plasma (PRP) have been used with temporomandibular joint (TMJ) arthrocentesis to improve lubricative properties and influence regenerative processes. A randomized, controlled clinical trial investigated the benefits of complementary bioviscosuplementation (HA+PRP) in patients submitted to double-portal TMJ arthrocentesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HA injection | Placebo comparator | Procedure: Double-puncture TMJ arthrocentesis under local anaesthesiaAfter TMJ double-puncture arthrocenthesis under local anesthesia, hyaluronic acid (Suplasyn®, 20 mg/ml) will be injected in the joint with the first portal. |
| HA + PRP injection | Active comparator | Procedure: Double-puncture TMJ arthrocentesis under local anaesthesia32ml of venous blood per joint will be collected and added to four 8ml-collection tubes containing sodium citrate. Then, blood will be centrifugated at 800rpm for 8 minutes at room temperature. 3 layers are perceptible: (1)layer with platelet-rich plasma and growth factors; (2)layer with white blood cells; (3)layer corresponding to red blood cells. Then, the total plasma volume will be calculated, and the plasma corresponding to the first fraction (low platelet fraction) aspirated. The second fraction of the first layer corresponding to PRP, above the white blood cell layer, will be removed and transferred to new tubes. 10 minutes before the mixing with HA, a calcium chloride-rich activator (Endoret ®, BTI Biotechnology Institute, Vitoria-Gasteiz, Álava, Spain) will be added to the PRP. The mixture of PRP with HA was then carried out at a ratio of 1cc of low molecular weight HA (Suplasyn®, 20 mg/ml) +1cc of PRP and introduced in the joint with the first portal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (1) age >18 years; (2) history of conservative treatment for TMD without significant improvement for at least three months; (3) clinical diagnosis of unilateral or bilateral intra-articular disorder; (3) clinical criteria for unilateral or bilateral TMJ arthrocentesis; (4) magnetic resonance imaging (MRI) and computed tomography (CT) documenting arthrogenous derangement.
Key exclusion criteria (1 listed)
- The exclusion criteria included: 1) any history of previous TMJ surgical intervention or any facial trauma within the last 4 weeks before the study; 2) concomitant other contralateral TMJ surgery; 3) severe medical problems or mental illness and pregnancy.
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 |
|---|---|---|
| Double-puncture TMJ arthrocentesis under local anaesthesiaThe first puncture involved carefully palpating the lateral rim of the glenoid fossa. A 5-cc syringe was prepared with a mixture of 3 cc of Ringer lactate and 1.8 cc of lidocaine with epinephrine. A 21-G needle connected to the syringe was gently inserted into the TMJ skin area. Once the needle tip made contact with the posterior slope of the eminence of the upper joint compartment, it was oriented vertically to access the upper compartment, allowing the surgeon to perform a validation step. For the second puncture, the joint was maintained at maximum distention with continuous inflow through the first portal, while the surgeon felt insufflation/distention in the anterior joint area. The second portal was established using a 21-G needle with successful fluid outflow. After completing an effective circuit, joint washing was carried out using intra-articular hydraulic pressure with at least 150 ml of Ringer lactate solution. | Procedure or surgery | HA + PRP injection, HA injection |
Primary outcome
TMJ arthralgia (VAS, 0-10)
Time frame: TMJ arthralgia will be assessed preoperatively (T0) and postoperatively (T1 - 1 month, T2 - 3 months, T3 - 6 months, T4 - 12 months follow-up).
The level of TMJ arthralgia was registered through pain during palpation of the lateral pole or around the lateral pole or pain on maximum unassisted or assisted opening, right or left lateral movements, or protrusive movements, following the DC/TMD guidelines.12, 13 Patient scored for each side using a 10-point VAS, from 0-no pain and 10-severe pain.
1 secondary outcome
maximum mouth opening (MMO)
Time frame: MMO will be assessed preoperatively (T0) and postoperatively (T1 - 1 month, T2 - 3 months, T3 - 6 months, T4 - 12 months follow-up).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 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 Double-puncture TMJ arthrocentesis under local anaesthesia 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 1 inclusion and 1 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 13 Jun 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 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.
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 arthralgia (VAS, 0-10) (time frame: TMJ arthralgia will be assessed preoperatively (T0) and postoperatively (T1 - 1 month, T2 - 3 months, T3 - 6 months, T4 - 12 months follow-up).). 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 Jun 2024.