Temporomandibular ArthritisNCT07571265
Intra-articular Injection for the Relief of Temporomandibular Joint Pain
A study testing platelet rich plasma and triamcinolone acetonide and hyaluronic acid and saline intra articular injection in people with Temporomandibular Arthritis, run by Cairo University at 1 site in Egypt.
Trial summary
Which is more effective in the treatment of nonspecific temporomandibular osteoarthritis: platelet-rich plasma (PRP), hyaluronic acid, or triamcinolone acetonide? Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Arthritis
- What is being tested?
- platelet rich plasma and triamcinolone acetonide and hyaluronic acid and saline intra articular injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2024to 25 Oct 2025
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Patients with temporomandibular joint osteoarthritis with or without disc displacement.
- 2. Age ≥ 18 years < 50
Who cannot join
- 1. Previous TMJ surgery
- 2. Medical history of blood-derived illness or any medication known to affect platelet function or concentration for a minimum of two weeks prior to treatment.
- 3. specific osteoarthritis like rheumatoid arthritis or psoriatic arthritis.
- 4. pregnant women or breastfeeding ones
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study on the Impact of Intra-articular Injections of Hyaluronic Acid, Platelet-rich Plasma and Triamcinolone Acetonide on the Relief of Temporomandibular Joint Pain
Which is more effective in the treatment of nonspecific temporomandibular osteoarthritis: platelet-rich plasma (PRP), hyaluronic acid, or triamcinolone acetonide?
Read the detailed description
Osteoarthritis is a degenerative condition that affects the TMJ. This condition may affect other joints in the hands, feet, or spine. The progressive destruction of the fibrocartilage layers with or without bone destruction and loss of the synovial fluid leads eventually to the accumulation of the inflammatory mediators. And when the episodes of destruction exceed that of healing, the patients start to encounter cycles of pain, inflammation, earache, limitation of mouth opening, and loss of function. Many treatment modalities have been illustrated in the literature for the treatment of osteoarthritis. One of the most effective treatment modalities used is intra-articular injections.
The first treatment strategy in this research is intra-articular injections of hyaluronic acid. Hyaluronic acid is a high molecular weight glycosaminoglycan composed of repeated chains of disaccharides. HLA is considered a normal component of numerous body structures and body fluids, like the synovial fluid, and is conjugated with many processes, like tissue repair and inflammation. So many authors advocate its usefulness in the treatment of temporomandibular dysfunction and myofascial pain without any complications or adverse effects.
The second treatment arm will be used for corticosteroids as intra-articular injections, and that's because of their long-standing and powerful anti-inflammatory properties alone or with local anesthetics for relief or treatment of temporomandibular joint symptoms.
Platelet-rich plasma is concentrated from the patient's own blood sample by centrifugation. It was first introduced in maxillofacial and plastic surgery in 1990. It's claimed that it has many advantages because of its healing potential, cell recruitment, proliferation, and differentiation, which lead eventually to tissue repair.
In this research, we are going to compare the effectiveness of three treatment arms: platelet-rich plasma, hyaluronic acid, and triamcinolone acetonide.
- Conditions
- Temporomandibular Arthritis
- Being tested
- platelet rich plasma and triamcinolone acetonide and hyaluronic acid and saline intra articular injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
platelet rich plasma and triamcinolone acetonide and hyaluronic acid and saline intra articular injectionOther
- An 18-gauge needle of a 10 ml plastic syringe loaded with normal saline solution will be inserted into the superior joint compartment (SJC). The injection-ejection process was repeated 10 times. Then the SJC will be injected with 1 ml of PRP in group I, 1 ml of triamcinolone acetonide 40 mg/ml in group II, 1 ml of hyaluronic acid (Hyalgan 20 mg/2 ml) in group III, or 1 ml of normal saline in group IV.
- Patients will be evaluated after one week and 1 month, then at 3 months and 6 months.
| Study group | Role | What they receive |
|---|---|---|
| platelet rich plasma(PRP) | Active comparator | * The surgical field will be prepared using alcohol before injection.
* The entrance point for intraarticular injection is located along the canthotragal line, 10 mm from the middle of the tragus and 2 mm below the line.
* Auriculotemporal nerve block anesthesia will be performed.
* An 18-gauge needle of a 10 ml plastic syringe loaded with normal saline solution will be inserted into the superior joint compartment (SJC). The injection-ejection process was repeated 10 times. Then the SJC will be injected with 1 ml of PRP, and Patients will be evaluated after one week, 1 month, and then at 3 months. and 6 months Receives: Other: platelet rich plasma and triamcinolone acetonide and hyaluronic acid and saline intra articular injection |
| triamcinolone acetonide | Active comparator | * The surgical field will be prepared using alcohol before injection.
* The entrance point for intraarticular injection is located along the canthotragal line, 10 mm from the middle of the tragus and 2 mm below the line.
* Auriculotemporal nerve block anesthesia will be performed.
* An 18-gauge needle of a 10 ml plastic syringe loaded with normal saline solution will be inserted into the superior joint compartment (SJC). The injection-ejection process was repeated 10 times. Then the SJC will be injected with 1 ml of epirelefan (triamcinolone acetonide) 40 mg/ml, and patients will be evaluated after one week, 1 month, and then at 3 months. and 6 months Receives: Other: platelet rich plasma and triamcinolone acetonide and hyaluronic acid and saline intra articular injection |
| hyaluronic acid | Active comparator | * The surgical field will be prepared using alcohol before injection.
* The entrance point for intraarticular injection is located along the canthotragal line, 10 mm from the middle of the tragus and 2 mm below the line.
* Auriculotemporal nerve block anesthesia will be performed.
* An 18-gauge needle of a 10 ml plastic syringe loaded with normal saline solution will be inserted into the superior joint compartment (SJC). The injection-ejection process was repeated 10 times. Then the SJC will be injected with 1 ml of Hyalgan (hyaluronic acid) 20 mg/2 ml, and patients will be evaluated after one week, 1 month, and then 3 months. and 6 months Receives: Other: platelet rich plasma and triamcinolone acetonide and hyaluronic acid and saline intra articular injection |
| saline(placebo) | Placebo comparator | * The surgical field will be prepared using alcohol before injection.
* The entrance point for intraarticular injection is located along the canthotragal line, 10 mm from the middle of the tragus and 2 mm below the line.
* Auriculotemporal nerve block anesthesia will be performed.
* An 18-gauge needle of a 10 ml plastic syringe loaded with normal saline solution will be inserted into the superior joint compartment (SJC). The injection-ejection process was repeated 10 times. Then the SJC will be injected with 1 ml of saline, and patients will be evaluated after one week, 1 month, and then at 3 months. and 6 months Receives: Other: platelet rich plasma and triamcinolone acetonide and hyaluronic acid and saline intra articular injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity
The patient's temporomandibular joint pain was felt by the patient on the visual analog scale from numbers 1 to 10.
Measured: preoperative as baseline then after one week, 1 month, 3 months and 6 months
pain-free mouth opening
The maximum mouth opening measured with a caliper in millimeters.
Measured: preoperative as baseline then after one week, 1 month, 3 months and 6 months
Secondary outcomes (1)
crepitus sounds
asking the patient at every appointment
Measured: preoperative as baseline then after one week, 1 month, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start1 May 2024
- Primary completion25 Aug 2025
- Study completion25 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular ArthritisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- * The surgical field will be prepared using alcohol before injection. * The entrance point for intraarticular injection is located along the canthotragal line, 10 mm from the middle of the tragus and 2 mm below the line. * Auriculotemporal nerve block anesthesia will be performed. * An 18-gauge needle of a 10 ml plastic syringe loaded with normal saline solution will be inserted into the superior joint compartment (SJC). The injection-ejection process was repeated 10 times. Then the SJC will be injected with 1 ml of PRP in group I, 1 ml of triamcinolone acetonide 40 mg/ml in group II, 1 ml of hyaluronic acid (Hyalgan 20 mg/2 ml) in group III, or 1 ml of normal saline in group IV. * Patients will be evaluated after one week, 1 month, and then at 3 months and 6 months.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohamed mostafa abd el khalek mohamed, Cairo University
- Investigators
- Mohamed MA el saadany, master, Principal investigator, mohamed_mostafa@dentistry.cu.edu.eg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07571265
- Sponsor's protocol ID
- Intra articular injections
- Status last verified
- Apr 2026
- First submitted
- 30 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data is available with the corresponding author on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study on the Impact of Intra-articular Injections of Hyaluronic Acid, Platelet-rich Plasma and Triamcinolone Acetonide on the Relief of Temporomandibular Joint Pain
- ClinicalTrials.gov ID
- NCT07571265
- Acronym / sponsor ID
- Intra articular injections
- Conditions
- Temporomandibular Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 25 Aug 2025 (actual)
- Study completion
- 25 Oct 2025 (actual)
- First posted
- 6 May 2026 (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.
Which is more effective in the treatment of nonspecific temporomandibular osteoarthritis: platelet-rich plasma (PRP), hyaluronic acid, or triamcinolone acetonide?
Detailed description
Osteoarthritis is a degenerative condition that affects the TMJ. This condition may affect other joints in the hands, feet, or spine. The progressive destruction of the fibrocartilage layers with or without bone destruction and loss of the synovial fluid leads eventually to the accumulation of the inflammatory mediators. And when the episodes of destruction exceed that of healing, the patients start to encounter cycles of pain, inflammation, earache, limitation of mouth opening, and loss of function. Many treatment modalities have been illustrated in the literature for the treatment of osteoarthritis. One of the most effective treatment modalities used is intra-articular injections.
The first treatment strategy in this research is intra-articular injections of hyaluronic acid. Hyaluronic acid is a high molecular weight glycosaminoglycan composed of repeated chains of disaccharides. HLA is considered a normal component of numerous body structures and body fluids, like the synovial fluid, and is conjugated with many processes, like tissue repair and inflammation. So many authors advocate its usefulness in the treatment of temporomandibular dysfunction and myofascial pain without any complications or adverse effects.
The second treatment arm will be used for corticosteroids as intra-articular injections, and that's because of their long-standing and powerful anti-inflammatory properties alone or with local anesthetics for relief or treatment of temporomandibular joint symptoms.
Platelet-rich plasma is concentrated from the patient's own blood sample by centrifugation. It was first introduced in maxillofacial and plastic surgery in 1990. It's claimed that it has many advantages because of its healing potential, cell recruitment, proliferation, and differentiation, which lead eventually to tissue repair.
In this research, we are going to compare the effectiveness of three treatment arms: platelet-rich plasma, hyaluronic acid, and triamcinolone acetonide.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- * The surgical field will be prepared using alcohol before injection. * The entrance point for intraarticular injection is located along the canthotragal line, 10 mm from the middle of the tragus and 2 mm below the line. * Auriculotemporal nerve block anesthesia will be performed. * An 18-gauge needle of a 10 ml plastic syringe loaded with normal saline solution will be inserted into the superior joint compartment (SJC). The injection-ejection process was repeated 10 times. Then the SJC will be injected with 1 ml of PRP in group I, 1 ml of triamcinolone acetonide 40 mg/ml in group II, 1 ml of hyaluronic acid (Hyalgan 20 mg/2 ml) in group III, or 1 ml of normal saline in group IV. * Patients will be evaluated after one week, 1 month, and then at 3 months and 6 months.
| Arm | Type | Receives |
|---|---|---|
| platelet rich plasma(PRP) | Active comparator | Other: platelet rich plasma and triamcinolone acetonide and hyaluronic acid and saline intra articular injection* The surgical field will be prepared using alcohol before injection. * The entrance point for intraarticular injection is located along the canthotragal line, 10 mm from the middle of the tragus and 2 mm below the line. * Auriculotemporal nerve block anesthesia will be performed. * An 18-gauge needle of a 10 ml plastic syringe loaded with normal saline solution will be inserted into the superior joint compartment (SJC). The injection-ejection process was repeated 10 times. Then the SJC will be injected with 1 ml of PRP, and Patients will be evaluated after one week, 1 month, and then at 3 months. and 6 months |
| triamcinolone acetonide | Active comparator | Other: platelet rich plasma and triamcinolone acetonide and hyaluronic acid and saline intra articular injection* The surgical field will be prepared using alcohol before injection. * The entrance point for intraarticular injection is located along the canthotragal line, 10 mm from the middle of the tragus and 2 mm below the line. * Auriculotemporal nerve block anesthesia will be performed. * An 18-gauge needle of a 10 ml plastic syringe loaded with normal saline solution will be inserted into the superior joint compartment (SJC). The injection-ejection process was repeated 10 times. Then the SJC will be injected with 1 ml of epirelefan (triamcinolone acetonide) 40 mg/ml, and patients will be evaluated after one week, 1 month, and then at 3 months. and 6 months |
| hyaluronic acid | Active comparator | Other: platelet rich plasma and triamcinolone acetonide and hyaluronic acid and saline intra articular injection* The surgical field will be prepared using alcohol before injection. * The entrance point for intraarticular injection is located along the canthotragal line, 10 mm from the middle of the tragus and 2 mm below the line. * Auriculotemporal nerve block anesthesia will be performed. * An 18-gauge needle of a 10 ml plastic syringe loaded with normal saline solution will be inserted into the superior joint compartment (SJC). The injection-ejection process was repeated 10 times. Then the SJC will be injected with 1 ml of Hyalgan (hyaluronic acid) 20 mg/2 ml, and patients will be evaluated after one week, 1 month, and then 3 months. and 6 months |
| saline(placebo) | Placebo comparator | Other: platelet rich plasma and triamcinolone acetonide and hyaluronic acid and saline intra articular injection* The surgical field will be prepared using alcohol before injection. * The entrance point for intraarticular injection is located along the canthotragal line, 10 mm from the middle of the tragus and 2 mm below the line. * Auriculotemporal nerve block anesthesia will be performed. * An 18-gauge needle of a 10 ml plastic syringe loaded with normal saline solution will be inserted into the superior joint compartment (SJC). The injection-ejection process was repeated 10 times. Then the SJC will be injected with 1 ml of saline, and patients will be evaluated after one week, 1 month, and then at 3 months. and 6 months |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 1. Patients with temporomandibular joint osteoarthritis with or without disc displacement.
- 2. Age ≥ 18 years < 50
Key exclusion criteria (4 listed)
- 1. Previous TMJ surgery
- 2. Medical history of blood-derived illness or any medication known to affect platelet function or concentration for a minimum of two weeks prior to treatment.
- 3. specific osteoarthritis like rheumatoid arthritis or psoriatic arthritis.
- 4. pregnant women or breastfeeding ones
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 |
|---|---|---|
| platelet rich plasma and triamcinolone acetonide and hyaluronic acid and saline intra articular injection* An 18-gauge needle of a 10 ml plastic syringe loaded with normal saline solution will be inserted into the superior joint compartment (SJC). The injection-ejection process was repeated 10 times. Then the SJC will be injected with 1 ml of PRP in group I, 1 ml of triamcinolone acetonide 40 mg/ml in group II, 1 ml of hyaluronic acid (Hyalgan 20 mg/2 ml) in group III, or 1 ml of normal saline in group IV. * Patients will be evaluated after one week and 1 month, then at 3 months and 6 months. | Other | hyaluronic acid, platelet rich plasma(PRP), saline(placebo), triamcinolone acetonide |
Primary outcome
pain intensity
Time frame: preoperative as baseline then after one week, 1 month, 3 months and 6 months
The patient's temporomandibular joint pain was felt by the patient on the visual analog scale from numbers 1 to 10.
pain-free mouth opening
Time frame: preoperative as baseline then after one week, 1 month, 3 months and 6 months
The maximum mouth opening measured with a caliper in millimeters.
1 secondary outcome
crepitus sounds
Time frame: preoperative as baseline then after one week, 1 month, 3 months and 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 6 May 2026.
- Individual participant dataSharing planned: No. The data is available with the corresponding author on reasonable request
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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.
Mohamed MA el saadany, master principal investigator
mohamed_mostafa@dentistry.cu.edu.eg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing platelet rich plasma and triamcinolone acetonide and hyaluronic acid and saline intra articular injection in people with Temporomandibular Arthritis, run by Cairo University at 1 site in Egypt.
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 2 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 6 May 2026. 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 Egypt. 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?
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?
pain intensity (time frame: preoperative as baseline then after one week, 1 month, 3 months and 6 months). The study lists 2 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 6 May 2026.