Temporomandibular Joint DisordersPhase 4NCT06530745
PRP vs HA Intra-articular Injections in TMDs
A Phase 4 study testing Hyaluronic acid (HA) injection and Platelet-rich plasma (PRP) injection in people with Temporomandibular Joint Disorders and Temporomandibular Joint Pain, run by Hospital of the Ministry of Interior, Kielce, Poland at 1 site in Poland.
Trial summary
This clinical trial aims to compare the multidirectional mandibular mobility following the treatment of TMJ disorders with same-protocol intra-articular injections of PRP and HA. It is questioned whether there is direct clinical evidence of the superiority of PRP or HA in the injection treatment of TMJ disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Temporomandibular Joint Disorders, Temporomandibular Joint Pain
- What is being tested?
- Hyaluronic acid (HA) injection and Platelet-rich plasma (PRP) injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 sitePoland
- Study dates
- 18 Jul 2024to 8 Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ICOP 2020 diagnosis of TMJ pain;
- informed consent to participate in the study;
- the possibility of discontinuing the current treatment of the temporomandibular joints;
- generally accepted indications for injection therapy.
Who cannot join
- active cancer;
- hematopoietic system disease or bleeding diathesis;
- temporomandibular joint prosthesis;
- temporomandibular joint ankylosis;
- skin disease of the preauricular area of the affected side.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quintuple Intra-Articular Hyaluronic Acid (HA) Improves and Platelet-Rich Plasma (PRP) Does Not Affect Mandibular Mobility in Temporomandibular Joint (TMJ) Disorders: A Controlled Trial
This clinical trial aims to compare the multidirectional mandibular mobility following the treatment of TMJ disorders with same-protocol intra-articular injections of PRP and HA. It is questioned whether there is direct clinical evidence of the superiority of PRP or HA in the injection treatment of TMJ disorders.
Read the detailed description
This study was designed as a two-arm equal-allocation clinical trial with a non-concurrent active treatment control. The study group consisted of consecutive patients receiving PRP injections into the TMJ cavities. The control group consisted of the same number of patients who received HA according to the same protocol. Controls were recruited consecutively, men and women separately, to maintain a consistent male-to-female ratio. The main condition for recruitment was the diagnosis of TMJ pain by a specialist in orthodontics or dental prosthetics and, on this basis, a referral for injection treatment. TMJ pain was diagnosed under the ICOP 2020 guidelines. The treatment was performed at the Maxillofacial Surgery Clinic in Kielce, Poland. The study group received PRP from peripheral venous blood of the elbow bend centrifuged at 160 revolutions per minute for 5 minutes with iFuge D06 (Neuation Technologies Pvt. Ltd, Gujarat, India). The control group received 2% hyaluronic acid Synocrom Forte (Croma-Pharma GmbH, Leobendorf, Austria). In both groups, 0.4 mL of the solution was injected per joint.
- Being tested
- Hyaluronic acid (HA) injection, Platelet-rich plasma (PRP) injection
- 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.
Hyaluronic acid (HA) injectionProcedure or surgery
2% hyaluronic acid Synocrom Forte (Croma-Pharma GmbH, Leobendorf, Austria) injection
Platelet-rich plasma (PRP) injectionProcedure or surgery
PRP from peripheral venous blood of the elbow bend centrifuged at 160 revolutions per minute for 5 minutes with iFuge D06 (Neuation Technologies Pvt. Ltd, Gujarat, India) injection
| Study group | Role | What they receive |
|---|---|---|
| PRP receiving group | Experimental | Patients receiving platelet-rich plasma injections into temporomandibular joints. Receives: Procedure: Platelet-rich plasma (PRP) injection |
| HA receiving group | Active comparator | Patients receiving hyaluronic acid injections into temporomandibular joints. Receives: Procedure: Hyaluronic acid (HA) injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mandibular abduction
Range of mandibular abduction between anthropometric points Incision superius (Is) and Incision inferius (Ii)
Measured: 0 - 6 months
Mandibular protrusion
Range of mandibular abduction between anthropometric points Incision superius (Is) and Incision inferius (Ii)
Measured: 0 - 6 months
Mandibular right movement
Range of mandibular abduction between anthropometric points Incision superius (Is) and Incision inferius (Ii)
Measured: 0 - 6 months
Mandibular left movement
Range of mandibular abduction between anthropometric points Incision superius (Is) and Incision inferius (Ii)
Measured: 0 - 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start18 Jul 2024
- Primary completion29 Jul 2024
- Study completion8 Aug 2024
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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study was designed as a two-arm equal-allocation clinical trial with a non-concurrent active treatment control.
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital of the Ministry of Interior, Kielce, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maciej Sikora, dr hab., Study chair, Hospital of the Ministry of Interior, Wojska Polskiego 51, 25-375 Kielce, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06530745
- Sponsor's protocol ID
- CT/2024/1
- Status last verified
- Mar 2025
- First submitted
- 27 Jul 2024
- Last updated
- 1 Apr 2025
- 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 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quintuple Intra-Articular Hyaluronic Acid (HA) Improves and Platelet-Rich Plasma (PRP) Does Not Affect Mandibular Mobility in Temporomandibular Joint (TMJ) Disorders: A Controlled Trial
- ClinicalTrials.gov ID
- NCT06530745
- Acronym / sponsor ID
- CT/2024/1
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Hospital of the Ministry of Interior, Kielce, PolandUniversity, hospital or other
- Study start
- 18 Jul 2024 (actual)
- Primary completion
- 29 Jul 2024 (actual)
- Study completion
- 8 Aug 2024 (actual)
- First posted
- 31 Jul 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.
This clinical trial aims to compare the multidirectional mandibular mobility following the treatment of TMJ disorders with same-protocol intra-articular injections of PRP and HA. It is questioned whether there is direct clinical evidence of the superiority of PRP or HA in the injection treatment of TMJ disorders.
Detailed description
This study was designed as a two-arm equal-allocation clinical trial with a non-concurrent active treatment control. The study group consisted of consecutive patients receiving PRP injections into the TMJ cavities. The control group consisted of the same number of patients who received HA according to the same protocol. Controls were recruited consecutively, men and women separately, to maintain a consistent male-to-female ratio. The main condition for recruitment was the diagnosis of TMJ pain by a specialist in orthodontics or dental prosthetics and, on this basis, a referral for injection treatment. TMJ pain was diagnosed under the ICOP 2020 guidelines. The treatment was performed at the Maxillofacial Surgery Clinic in Kielce, Poland. The study group received PRP from peripheral venous blood of the elbow bend centrifuged at 160 revolutions per minute for 5 minutes with iFuge D06 (Neuation Technologies Pvt. Ltd, Gujarat, India). The control group received 2% hyaluronic acid Synocrom Forte (Croma-Pharma GmbH, Leobendorf, Austria). In both groups, 0.4 mL of the solution was injected per joint.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study was designed as a two-arm equal-allocation clinical trial with a non-concurrent active treatment control.
| Arm | Type | Receives |
|---|---|---|
| PRP receiving group | Experimental | Procedure: Platelet-rich plasma (PRP) injectionPatients receiving platelet-rich plasma injections into temporomandibular joints. |
| HA receiving group | Active comparator | Procedure: Hyaluronic acid (HA) injectionPatients receiving hyaluronic acid injections into temporomandibular joints. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ICOP 2020 diagnosis of TMJ pain;
- informed consent to participate in the study;
- the possibility of discontinuing the current treatment of the temporomandibular joints;
- generally accepted indications for injection therapy.
Key exclusion criteria (5 listed)
- active cancer;
- hematopoietic system disease or bleeding diathesis;
- temporomandibular joint prosthesis;
- temporomandibular joint ankylosis;
- skin disease of the preauricular area of the affected side.
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 |
|---|---|---|
| Hyaluronic acid (HA) injection2% hyaluronic acid Synocrom Forte (Croma-Pharma GmbH, Leobendorf, Austria) injection | Procedure or surgery | HA receiving group |
| Platelet-rich plasma (PRP) injectionPRP from peripheral venous blood of the elbow bend centrifuged at 160 revolutions per minute for 5 minutes with iFuge D06 (Neuation Technologies Pvt. Ltd, Gujarat, India) injection | Procedure or surgery | PRP receiving group |
Primary outcome
Mandibular abduction
Time frame: 0 - 6 months
Range of mandibular abduction between anthropometric points Incision superius (Is) and Incision inferius (Ii)
Mandibular protrusion
Time frame: 0 - 6 months
Range of mandibular abduction between anthropometric points Incision superius (Is) and Incision inferius (Ii)
Mandibular right movement
Time frame: 0 - 6 months
Range of mandibular abduction between anthropometric points Incision superius (Is) and Incision inferius (Ii)
Mandibular left movement
Time frame: 0 - 6 months
Range of mandibular abduction between anthropometric points Incision superius (Is) and Incision inferius (Ii)
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 2025.
- 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.
Maciej Sikora, dr hab. study chair
Hospital of the Ministry of Interior, Wojska Polskiego 51, 25-375 Kielce, Poland
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 Hyaluronic acid (HA) injection and Platelet-rich plasma (PRP) injection in people with Temporomandibular Joint Disorders and Temporomandibular Joint Pain, run by Hospital of the Ministry of Interior, Kielce, Poland at 1 site in Poland.
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 4 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 2025. 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 Poland. 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.
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?
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?
Mandibular abduction (time frame: 0 - 6 months). The study lists 4 primary outcomes in all. 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 1 Apr 2025.