Internal DerangementNCT07598253
Intra-articular Injection of Medications in TMJ After Arthrocentsis
A study testing Arthrocentesis with ringer solution in people with Internal Derangement, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study: to evaluate the injection of hyaluronic acid and corticosteroids mixture leads to better clinical outcomes in terms of improve maximum mouth opening and reduce pain compared with hyaluronic acid and prp mixture in patients with TMJ internal derangement . Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Internal Derangement
- What is being tested?
- Arthrocentesis with ringer solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult
Who may be able to join
- Patients should have one or more signs and symptoms of these
- Symptoms: Patients who report typical symptoms of TMJ dysfunction, such as pain, discomfort, or clicking sounds in the joint, especially when opening or closing the mouth.
- Mouth Opening: Limited range of motion or difficulty with full mouth opening.
- Clicking: Audible clicking.
- Pain: Pain or tenderness around the TMJ, often radiating to the ear, temple, or neck.
Who cannot join
- * Previously diagnosed hematological and neurological conditions;
- Previous malignant head and neck neoplasms;
- Uncooperative patients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of dentistry cairo university
Cairo, Cairo Governorate, 11553
Omar Hamdy Negm, BDS oforal and dental medicine, +20 1002006335, omarhamdynegm@gmail.com
About this study
Official title: Evaluation of the Efficacy of Intra-articular Injection of Hyaluronic Acid and Corticosteroids Mixture Versus Hyaluronic Acid and Platelet Rich Plasma Mixture After Arthrocentesis in Anterior Disc Displacement With Reduction: A Randomized Clinical Trial
The aim of this study: to evaluate the injection of hyaluronic acid and corticosteroids mixture leads to better clinical outcomes in terms of improve maximum mouth opening and reduce pain compared with hyaluronic acid and prp mixture in patients with TMJ internal derangement .
Read the detailed description
II. Introduction:
- Background and rationale: Research question? In patients with anterior disc displacement with reduction, what is the therapeutic effect of intra-articular injection of hyaluronic acid and corticosteroids mixture after arthrocentesis versus hyaluronic acid and prp mixture after arthrocentesis in terms of jaw movement, pain relief, decreasing clicking and frequency of locking?
Statement of the problem:
Internal derangement and osteoarthritis are the most common degenerative temporomandibular joint diseases.
Hyaluronic acid and corticosteroids mixture have been proved in literature to represent a more effective method to preserve and treat joints (knee joints and temporomandibular joints)
Rationale for conducting the research:
The rationale of this procedure is to remove inflammatory mediators, reduce friction, stimulate the production of new synovial fluid, eliminate suction-cup effect.
The purpose of this study was to evaluate the hypothesis that TMJ injection of hyaluronic acid and corticosteroids mixture after arthrocentesis leads to better clinical outcomes in terms of reducing pain and improving function compared with injection of hyaluronic acid and prp mixture after arthrocentesis in patients with TMJ internal derangement and osteoarthritis Preliminary results of this clinical trial show that the injection of hyaluronic acid and corticosteroids mixture can significantly improve outcomes of pain and function compared with the standard treatment and encourage to pursue research on this topic.
Further studies with a longer follow-up time are needed to evaluate the clinical stability of the achieved improvement in pain and function.
For this reason, this protocol has been designed with the aim to investigate whether injection in the TMJ of hyaluronic acid and corticosteroids mixture after can achieve the same improvements of pain and function, compare this technique with hyaluronic acid and platelet rich plasma mixture injection.
Review of literature Anterior disc displacement with reduction of the temporomandibular joint (TMJ) is a prevalent condition characterized by the displacement of the articular disc during jaw movement, often leading to pain, clicking sounds, and restricted mouth opening. Traditional treatments include conservative approaches such as physical therapy, occlusal splints, and pharmacological interventions. However, for patients unresponsive to these methods, intra-articular injections of therapies like hyaluronic acid, corticosteroids mixture and hyaluronic acid, platelet-rich plasma (PRP)mixture have emerged as promising alternatives.
Arthrocentesis is the simplest intervention on the TMJ with the aim to decrease joint pain and improve the range of motion in patients not responding to initial conservative treatment.
Arthrocentesis consists of an intraarticular lavage using 2 needles placed in the upper joint space. It is a versatile technique which can be performed under local anesthesia in an outpatient setting as well Arthrocentesis has been demonstrated to be a very effective procedure with a high success rate and a favorable benefit-cost ratio.
In addition to arthrocentesis:
Hyaluronic acid and corticosteroids mixture injection Introduction: Temporomandibular joint disorders (TMDs) represent a diverse group of conditions affecting the TMJ, masticatory muscles, and associated structures. Intra-articular injections of therapeutic agents, particularly Hyaluronic Acid (HA) and Corticosteroids (CS), have been utilized to reduce inflammation and improve joint mobility. Recently, studies have explored the combined use of HA and CS, aiming to capitalize on the anti-inflammatory effects of CS and the viscoelastic, lubricating, and regenerative properties of HA.
- Hyaluronic Acid in TMJ Disorders: HA is a natural component of synovial fluid and plays a critical role in joint lubrication and cartilage health. In a systematic review, intra-articular HA injections showed significant improvements in pain and jaw function in patients with TMDs HA promotes endogenous synthesis of proteoglycans, reduces cartilage degradation, and provides mechanical cushioning.
- Corticosteroids in TMJ Disorders: CS are potent anti-inflammatory agents that reduce joint pain and inflammation by inhibiting cytokine production and leukocyte infiltration. intra-articular CS injections lead to short-term pain relief but could result in cartilage damage if overused. Side effects of repeated CS injections may include joint degeneration and reduced joint space.
- Combined HA and CS Injections:
The combination aims to provide rapid pain relief (via CS) while enhancing joint lubrication and healing (via HA).
a randomized clinical trial comparing HA alone, CS alone, and a mixture of both. The HA+CS group showed faster pain relief and better functional recovery at early time points, although long-term outcomes were similar to HA alone.
Yilmaz : Found that the combined injection provided superior improvement in mouth opening and pain control compared to either agent alone.
HA+CS combination is effective in patients with internal derangement and osteoarthritis of the TMJ, especially when guided by ultrasound for accurate injection placement.
Hyaluronic acid and PRP mixture injection The synergistic effect of HA and PRP is hypothesized to enhance joint function and alleviate pain more effectively than either agent alone.
Clinical Evidence
Several studies have investigated the efficacy of HA and PRP combination therapy:
Synergistic Effect Study: A randomized controlled trial . demonstrated that patients receiving combined HA and PRP injections post-arthrocentesis experienced significant improvements in pain reduction and maximum mouth opening compared to those receiving either HA or PRP alone.
Comparative Study: evaluated the participation of HA with PRP in the treatment of TMJ disorders. Their study found that the combination therapy provided greater improvements in pain at mastication, masticatory efficiency, and functional limitation in mandibular movement over a 6-month follow-up period compared to HA alone.
Systematic Review: A systematic review indicated that while arthrocentesis alone effectively reduces pain and improves jaw function, additional injections of HA or PRP do not significantly enhance clinical outcomes. However, the combination of HA and PRP may offer synergistic benefits, though further high-quality studies are needed to confirm this.
Comparative Efficacy While both hyaluronic acid, corticosteroids mixture and hyaluronic acid, prp mixture injections have demonstrated efficacy in treating joint disorders, direct comparative studies in the context of TMJ anterior disc displacement with reduction are limited. The existing literature primarily focuses on individual therapies rather than head-to-head comparisons. Therefore, it is challenging to definitively conclude which treatment offers superior outcomes for TMJ disorders.
Explanation for choice of comparator
- The choice of a hyaluronic acid (HA) and corticosteroids (CS) mixture injection in the treatment of anterior disc displacement with reduction of the temporomandibular joint (TMJ) is based on anti-inflammatory effects to manage symptoms and improve joint function. Here's a breakdown of the rationale:
- Pathophysiology of Anterior disc displacement with reduction In Anterior disc displacement with reduction, the disc moves anteriorly during mouth closure and returns to its normal position during opening, often producing clicking sounds. Repetitive disc displacement can lead to synovial inflammation, joint effusion, and cartilage wear, which result in pain and functional limitation
- Why Hyaluronic Acid? Lubrication: HA restores the viscosity of synovial fluid, reducing friction between joint surfaces. Shock Absorption: It protects joint structures during mandibular movements. Anti-inflammatory effects: HA can inhibit inflammatory mediators like IL-1 and prostaglandins. Cartilage Protection: It promotes chondrocyte activity and slows down degenerative changes.
- Why Corticosteroids? Potent anti-inflammatory: CS reduce synovial inflammation quickly by suppressing cytokines and inflammatory cell activity. Pain relief: CS can rapidly decrease pain by reducing joint swelling and pressure. Short-term efficacy: Especially useful in acute or highly symptomatic cases.
- Why the Combination? Complementary action: CS provide rapid symptom relief, while HA supports longer-term joint health. Minimizing CS side effects: The addition of HA may protect cartilage from the potential degenerative effects of repeated CS exposure. Dual mechanism: The mixture addresses both inflammation (CS) and joint biomechanics (HA).
- Supporting Literature Studies have shown that while CS alone is effective short-term, HA has longer-lasting effects. The combination may result in better functional outcomes than either alone .
Some research indicates faster pain reduction and better improvement in mouth opening with HA+CS compared to monotherapy.
- The use of a combination of hyaluronic acid (HA) and platelet-rich plasma (PRP) in the treatment of anterior disc displacement with reduction of the temporomandibular joint (TMJ) is based on the need to address both the mechanical and biological components of the disorder. anterior disc displacement with reduction is characterized by anterior displacement of the articular disc during mandibular closure with spontaneous reduction upon opening, often accompanied by joint sounds, pain, and compromised function. Prolonged displacement can lead to joint inflammation, synovitis, and eventual structural degeneration if left untreated.
Hyaluronic acid, a key component of synovial fluid, plays a critical role in maintaining joint homeostasis by enhancing lubrication, reducing friction, and providing shock absorption. It also possesses mild anti-inflammatory properties and has been shown to inhibit the activity of pro-inflammatory cytokines such as interleukin-1 and tumor necrosis factor-alpha. Clinically, intra-articular HA injections have demonstrated efficacy in reducing TMJ pain and improving mandibular mobility.
Platelet-rich plasma, an autologous concentrate rich in growth factors such as platelet-derived growth factor (PDGF), transforming growth factor-beta (TGF-β), and vascular endothelial growth factor (VEGF), promotes tissue regeneration and modulates inflammation. In the TMJ context, PRP facilitates the healing of synovial tissues, , and other soft tissues affected by repetitive disc displacement.
The combination of HA and PRP is hypothesized to exert a synergistic therapeutic effect. While HA improves the viscoelastic properties of the synovial environment and provides mechanical protection, PRP contributes biological stimulation for tissue repair and regeneration. Moreover, HA may enhance the intra-articular retention and stability of PRP, prolonging its therapeutic action.
Recent studies support the clinical efficacy of HA and PRP combination therapy. a randomized controlled trial and found that patients receiving a single intra-articular injection of HA and PRP following arthrocentesis showed significantly greater improvements in maximum mouth opening and pain reduction compared to those treated with either agent alone (PMID: 36414172). Similarly, demonstrated that the combination therapy resulted in superior functional outcomes and reduced pain 7. Objectives: The aim of this study: to evaluate the injection of hyaluronic acid and corticosteroids mixture leads to better clinical outcomes in terms of improve maximum mouth opening and reduce pain compared with hyaluronic acid and platelet rich plasma mixture in patients with TMJ internal derangement .
Hypothesis: Null hypothesis This study is alternative hypothesis research based on that the technique will be more efficient and effective in lower height groups.
Primary objective:
To assess effect of hyaluronic acid and corticosteroids mixture in assessment of maximum mouth opening , pain , clicking and movements of jaw in patients with anterior disc displacement with reduction.
- Conditions
- Internal Derangement
- Being tested
- Arthrocentesis with ringer solution
- Keywords
- "Corticosteroids", "PRP", "Hyaluronic acid"
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthrocentesis with ringer solutionCombination product
HA + Corticosteroid Group Patients receive intra-articular injection of a hyaluronic acid (HA) and corticosteroid mixture after arthrocentesis.
Arthrocentesis with ringer solutionCombination product
HA + PRP Group Patients receive intra-articular injection of a hyaluronic acid (HA) and platelet-rich plasma (PRP) mixture after arthrocentesis
| Study group | Role | What they receive |
|---|---|---|
| Patients receive intra-articular injection of a hyaluronic acid and corticosteroids mixture | Active comparator | Arthrocentesis first described by Nitzan et al. [1.2] is the simplest intervention on the TMJ with the aim to decrease joint pain and improve the range of motion in patients not responding to initial conservative treatment.
Arthrocentesis consists of an intraarticular lavage using 2 needles placed in the upper joint space. It is a versatile technique which can be performed under local anesthesia in an outpatient setting as well Arthrocentesis has been demonstrated to be a very effective procedure with a high success rate and a favorable benefit-cost ratio.
In addition to arthrocentesis:
Hyaluronic acid and corticosteroids mixture injection Introduction: Temporomandibular joint disorders (TMDs) represent a diverse group of conditions affecting the TMJ, masticatory muscles, and associated structures. Intra-articular injections of therapeutic agents, particularly Hyaluronic Acid (HA) and Corticosteroids (CS), have been utilized to reduce inflammation and improve joint mobility. Recentl Receives: Combination Product: Arthrocentesis with ringer solution |
| Patients receive intra-articular injection of a hyaluronic acid (HA) and platelet-rich plasma | Experimental | Arthrocentesis first described by Nitzan et al. [1.2] is the simplest intervention on the TMJ with the aim to decrease joint pain and improve the range of motion in patients not responding to initial conservative treatment.
Arthrocentesis consists of an intraarticular lavage using 2 needles placed in the upper joint space. It is a versatile technique which can be performed under local anesthesia in an outpatient setting as well Arthrocentesis has been demonstrated to be a very effective procedure with a high success rate and a favorable benefit-cost ratio.double-puncture arthrocentesis technique was followed, and 300 mL of Ringer's lactate solution was used to irrigate the joint space through the marked points . After arthrocentesis standard treatment Preparation of platelet-rich plasma First, 5 ml blood is withdrawn from the patient. Then, blood is poured in a test-tube in which sodium citrate anticoagulant (0.5 ml) is already present. It is centrifuged at the rate of 2100 rpm for Receives: Combination Product: Arthrocentesis with ringer solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the efficacy of intra-articular injection of hyaluronic acid and corticosteroids mixture versus hyaluronic acid and platelet rich plasma mixture after arthrocentesis in anterior disc displacement with reduction
measuring maximum mouth opening using caliper to determine the opening in mm
Measured: 3 months
Secondary outcomes (1)
Evaluation of the efficacy of intra-articular injection of hyaluronic acid and corticosteroids mixture versus hyaluronic acid and platelet rich plasma mixture after arthrocentesis in anterior disc displacement with reduction
measuring pain using VAS scale from 0 to 10 , 0 means better ,and 10 means worse
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Internal DerangementStudies 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 participants will be randomly divided into two groups In group A (Hyaluronic acid and corticosteroids mixture injection): I - double-puncture arthrocentesis technique was followed, and 300 mL of Ringer's lactate solution was used to irrigate the joint space through the marked points. After arthrocentesis a mixture of 1-ml HA and 1-ml corticosteroid (Kenacort A-40: each ml contains triamcinolone acetonide 40mg. with sodium chloride manufactured by SmithKline Beecham, Egypt. An affiliated Co. to GlaxoSmithKline) was slowly injected. Each patient received a single injection, once the injection was completed and needles were removed, the patient's mandible was lightly manipulated in the vertical, protrusive, and lateral excursions to facilitate breaking down the adhesions and help additional freeing up
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Hamdy Negm, Cairo University
- Investigators
- Mohamed Ashraf Eissa, Assisstant professor, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07598253
- Sponsor's protocol ID
- TMJ Arthrocentesis
- Status last verified
- May 2026
- First submitted
- 1 Mar 2026
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Intra-articular Injection of Hyaluronic Acid and Corticosteroids Mixture Versus Hyaluronic Acid and Platelet Rich Plasma Mixture After Arthrocentesis in Anterior Disc Displacement With Reduction: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07598253
- Acronym / sponsor ID
- TMJ Arthrocentesis
- Conditions
- Internal Derangement
- Keywords
- "Corticosteroids", "PRP", "Hyaluronic acid"
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 20 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.
The aim of this study: to evaluate the injection of hyaluronic acid and corticosteroids mixture leads to better clinical outcomes in terms of improve maximum mouth opening and reduce pain compared with hyaluronic acid and prp mixture in patients with TMJ internal derangement .
Detailed description
II. Introduction:
- Background and rationale: Research question? In patients with anterior disc displacement with reduction, what is the therapeutic effect of intra-articular injection of hyaluronic acid and corticosteroids mixture after arthrocentesis versus hyaluronic acid and prp mixture after arthrocentesis in terms of jaw movement, pain relief, decreasing clicking and frequency of locking?
Statement of the problem:
Internal derangement and osteoarthritis are the most common degenerative temporomandibular joint diseases.
Hyaluronic acid and corticosteroids mixture have been proved in literature to represent a more effective method to preserve and treat joints (knee joints and temporomandibular joints)
Rationale for conducting the research:
The rationale of this procedure is to remove inflammatory mediators, reduce friction, stimulate the production of new synovial fluid, eliminate suction-cup effect.
The purpose of this study was to evaluate the hypothesis that TMJ injection of hyaluronic acid and corticosteroids mixture after arthrocentesis leads to better clinical outcomes in terms of reducing pain and improving function compared with injection of hyaluronic acid and prp mixture after arthrocentesis in patients with TMJ internal derangement and osteoarthritis Preliminary results of this clinical trial show that the injection of hyaluronic acid and corticosteroids mixture can significantly improve outcomes of pain and function compared with the standard treatment and encourage to pursue research on this topic.
Further studies with a longer follow-up time are needed to evaluate the clinical stability of the achieved improvement in pain and function.
For this reason, this protocol has been designed with the aim to investigate whether injection in the TMJ of hyaluronic acid and corticosteroids mixture after can achieve the same improvements of pain and function, compare this technique with hyaluronic acid and platelet rich plasma mixture injection.
Review of literature Anterior disc displacement with reduction of the temporomandibular joint (TMJ) is a prevalent condition characterized by the displacement of the articular disc during jaw movement, often leading to pain, clicking sounds, and restricted mouth opening. Traditional treatments include conservative approaches such as physical therapy, occlusal splints, and pharmacological interventions. However, for patients unresponsive to these methods, intra-articular injections of therapies like hyaluronic acid, corticosteroids mixture and hyaluronic acid, platelet-rich plasma (PRP)mixture have emerged as promising alternatives.
Arthrocentesis is the simplest intervention on the TMJ with the aim to decrease joint pain and improve the range of motion in patients not responding to initial conservative treatment.
Arthrocentesis consists of an intraarticular lavage using 2 needles placed in the upper joint space. It is a versatile technique which can be performed under local anesthesia in an outpatient setting as well Arthrocentesis has been demonstrated to be a very effective procedure with a high success rate and a favorable benefit-cost ratio.
In addition to arthrocentesis:
Hyaluronic acid and corticosteroids mixture injection Introduction: Temporomandibular joint disorders (TMDs) represent a diverse group of conditions affecting the TMJ, masticatory muscles, and associated structures. Intra-articular injections of therapeutic agents, particularly Hyaluronic Acid (HA) and Corticosteroids (CS), have been utilized to reduce inflammation and improve joint mobility. Recently, studies have explored the combined use of HA and CS, aiming to capitalize on the anti-inflammatory effects of CS and the viscoelastic, lubricating, and regenerative properties of HA.
- Hyaluronic Acid in TMJ Disorders: HA is a natural component of synovial fluid and plays a critical role in joint lubrication and cartilage health. In a systematic review, intra-articular HA injections showed significant improvements in pain and jaw function in patients with TMDs HA promotes endogenous synthesis of proteoglycans, reduces cartilage degradation, and provides mechanical cushioning.
- Corticosteroids in TMJ Disorders: CS are potent anti-inflammatory agents that reduce joint pain and inflammation by inhibiting cytokine production and leukocyte infiltration. intra-articular CS injections lead to short-term pain relief but could result in cartilage damage if overused. Side effects of repeated CS injections may include joint degeneration and reduced joint space.
- Combined HA and CS Injections:
The combination aims to provide rapid pain relief (via CS) while enhancing joint lubrication and healing (via HA).
a randomized clinical trial comparing HA alone, CS alone, and a mixture of both. The HA+CS group showed faster pain relief and better functional recovery at early time points, although long-term outcomes were similar to HA alone.
Yilmaz : Found that the combined injection provided superior improvement in mouth opening and pain control compared to either agent alone.
HA+CS combination is effective in patients with internal derangement and osteoarthritis of the TMJ, especially when guided by ultrasound for accurate injection placement.
Hyaluronic acid and PRP mixture injection The synergistic effect of HA and PRP is hypothesized to enhance joint function and alleviate pain more effectively than either agent alone.
Clinical Evidence
Several studies have investigated the efficacy of HA and PRP combination therapy:
Synergistic Effect Study: A randomized controlled trial . demonstrated that patients receiving combined HA and PRP injections post-arthrocentesis experienced significant improvements in pain reduction and maximum mouth opening compared to those receiving either HA or PRP alone.
Comparative Study: evaluated the participation of HA with PRP in the treatment of TMJ disorders. Their study found that the combination therapy provided greater improvements in pain at mastication, masticatory efficiency, and functional limitation in mandibular movement over a 6-month follow-up period compared to HA alone.
Systematic Review: A systematic review indicated that while arthrocentesis alone effectively reduces pain and improves jaw function, additional injections of HA or PRP do not significantly enhance clinical outcomes. However, the combination of HA and PRP may offer synergistic benefits, though further high-quality studies are needed to confirm this.
Comparative Efficacy While both hyaluronic acid, corticosteroids mixture and hyaluronic acid, prp mixture injections have demonstrated efficacy in treating joint disorders, direct comparative studies in the context of TMJ anterior disc displacement with reduction are limited. The existing literature primarily focuses on individual therapies rather than head-to-head comparisons. Therefore, it is challenging to definitively conclude which treatment offers superior outcomes for TMJ disorders.
Explanation for choice of comparator
- The choice of a hyaluronic acid (HA) and corticosteroids (CS) mixture injection in the treatment of anterior disc displacement with reduction of the temporomandibular joint (TMJ) is based on anti-inflammatory effects to manage symptoms and improve joint function. Here's a breakdown of the rationale:
- Pathophysiology of Anterior disc displacement with reduction In Anterior disc displacement with reduction, the disc moves anteriorly during mouth closure and returns to its normal position during opening, often producing clicking sounds. Repetitive disc displacement can lead to synovial inflammation, joint effusion, and cartilage wear, which result in pain and functional limitation
- Why Hyaluronic Acid? Lubrication: HA restores the viscosity of synovial fluid, reducing friction between joint surfaces. Shock Absorption: It protects joint structures during mandibular movements. Anti-inflammatory effects: HA can inhibit inflammatory mediators like IL-1 and prostaglandins. Cartilage Protection: It promotes chondrocyte activity and slows down degenerative changes.
- Why Corticosteroids? Potent anti-inflammatory: CS reduce synovial inflammation quickly by suppressing cytokines and inflammatory cell activity. Pain relief: CS can rapidly decrease pain by reducing joint swelling and pressure. Short-term efficacy: Especially useful in acute or highly symptomatic cases.
- Why the Combination? Complementary action: CS provide rapid symptom relief, while HA supports longer-term joint health. Minimizing CS side effects: The addition of HA may protect cartilage from the potential degenerative effects of repeated CS exposure. Dual mechanism: The mixture addresses both inflammation (CS) and joint biomechanics (HA).
- Supporting Literature Studies have shown that while CS alone is effective short-term, HA has longer-lasting effects. The combination may result in better functional outcomes than either alone .
Some research indicates faster pain reduction and better improvement in mouth opening with HA+CS compared to monotherapy.
- The use of a combination of hyaluronic acid (HA) and platelet-rich plasma (PRP) in the treatment of anterior disc displacement with reduction of the temporomandibular joint (TMJ) is based on the need to address both the mechanical and biological components of the disorder. anterior disc displacement with reduction is characterized by anterior displacement of the articular disc during mandibular closure with spontaneous reduction upon opening, often accompanied by joint sounds, pain, and compromised function. Prolonged displacement can lead to joint inflammation, synovitis, and eventual structural degeneration if left untreated.
Hyaluronic acid, a key component of synovial fluid, plays a critical role in maintaining joint homeostasis by enhancing lubrication, reducing friction, and providing shock absorption. It also possesses mild anti-inflammatory properties and has been shown to inhibit the activity of pro-inflammatory cytokines such as interleukin-1 and tumor necrosis factor-alpha. Clinically, intra-articular HA injections have demonstrated efficacy in reducing TMJ pain and improving mandibular mobility.
Platelet-rich plasma, an autologous concentrate rich in growth factors such as platelet-derived growth factor (PDGF), transforming growth factor-beta (TGF-β), and vascular endothelial growth factor (VEGF), promotes tissue regeneration and modulates inflammation. In the TMJ context, PRP facilitates the healing of synovial tissues, , and other soft tissues affected by repetitive disc displacement.
The combination of HA and PRP is hypothesized to exert a synergistic therapeutic effect. While HA improves the viscoelastic properties of the synovial environment and provides mechanical protection, PRP contributes biological stimulation for tissue repair and regeneration. Moreover, HA may enhance the intra-articular retention and stability of PRP, prolonging its therapeutic action.
Recent studies support the clinical efficacy of HA and PRP combination therapy. a randomized controlled trial and found that patients receiving a single intra-articular injection of HA and PRP following arthrocentesis showed significantly greater improvements in maximum mouth opening and pain reduction compared to those treated with either agent alone (PMID: 36414172). Similarly, demonstrated that the combination therapy resulted in superior functional outcomes and reduced pain 7. Objectives: The aim of this study: to evaluate the injection of hyaluronic acid and corticosteroids mixture leads to better clinical outcomes in terms of improve maximum mouth opening and reduce pain compared with hyaluronic acid and platelet rich plasma mixture in patients with TMJ internal derangement .
Hypothesis: Null hypothesis This study is alternative hypothesis research based on that the technique will be more efficient and effective in lower height groups.
Primary objective:
To assess effect of hyaluronic acid and corticosteroids mixture in assessment of maximum mouth opening , pain , clicking and movements of jaw in patients with anterior disc displacement with reduction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The participants will be randomly divided into two groups In group A (Hyaluronic acid and corticosteroids mixture injection): I - double-puncture arthrocentesis technique was followed, and 300 mL of Ringer's lactate solution was used to irrigate the joint space through the marked points. After arthrocentesis a mixture of 1-ml HA and 1-ml corticosteroid (Kenacort A-40: each ml contains triamcinolone acetonide 40mg. with sodium chloride manufactured by SmithKline Beecham, Egypt. An affiliated Co. to GlaxoSmithKline) was slowly injected. Each patient received a single injection, once the injection was completed and needles were removed, the patient's mandible was lightly manipulated in the vertical, protrusive, and lateral excursions to facilitate breaking down the adhesions and help additional freeing up
| Arm | Type | Receives |
|---|---|---|
| Patients receive intra-articular injection of a hyaluronic acid and corticosteroids mixture | Active comparator | Combination Product: Arthrocentesis with ringer solutionArthrocentesis first described by Nitzan et al. [1.2] is the simplest intervention on the TMJ with the aim to decrease joint pain and improve the range of motion in patients not responding to initial conservative treatment. Arthrocentesis consists of an intraarticular lavage using 2 needles placed in the upper joint space. It is a versatile technique which can be performed under local anesthesia in an outpatient setting as well Arthrocentesis has been demonstrated to be a very effective procedure with a high success rate and a favorable benefit-cost ratio. In addition to arthrocentesis: Hyaluronic acid and corticosteroids mixture injection Introduction: Temporomandibular joint disorders (TMDs) represent a diverse group of conditions affecting the TMJ, masticatory muscles, and associated structures. Intra-articular injections of therapeutic agents, particularly Hyaluronic Acid (HA) and Corticosteroids (CS), have been utilized to reduce inflammation and improve joint mobility. Recentl |
| Patients receive intra-articular injection of a hyaluronic acid (HA) and platelet-rich plasma | Experimental | Combination Product: Arthrocentesis with ringer solutionArthrocentesis first described by Nitzan et al. [1.2] is the simplest intervention on the TMJ with the aim to decrease joint pain and improve the range of motion in patients not responding to initial conservative treatment. Arthrocentesis consists of an intraarticular lavage using 2 needles placed in the upper joint space. It is a versatile technique which can be performed under local anesthesia in an outpatient setting as well Arthrocentesis has been demonstrated to be a very effective procedure with a high success rate and a favorable benefit-cost ratio.double-puncture arthrocentesis technique was followed, and 300 mL of Ringer's lactate solution was used to irrigate the joint space through the marked points . After arthrocentesis standard treatment Preparation of platelet-rich plasma First, 5 ml blood is withdrawn from the patient. Then, blood is poured in a test-tube in which sodium citrate anticoagulant (0.5 ml) is already present. It is centrifuged at the rate of 2100 rpm for |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients should have one or more signs and symptoms of these
Key exclusion criteria (3 listed)
- * Previously diagnosed hematological and neurological conditions;
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 |
|---|---|---|
| Arthrocentesis with ringer solutionHA + Corticosteroid Group Patients receive intra-articular injection of a hyaluronic acid (HA) and corticosteroid mixture after arthrocentesis. | Combination product | Patients receive intra-articular injection of a hyaluronic acid and corticosteroids mixture |
| Arthrocentesis with ringer solutionHA + PRP Group Patients receive intra-articular injection of a hyaluronic acid (HA) and platelet-rich plasma (PRP) mixture after arthrocentesis | Combination product | Patients receive intra-articular injection of a hyaluronic acid (HA) and platelet-rich plasma |
Primary outcome
Evaluation of the efficacy of intra-articular injection of hyaluronic acid and corticosteroids mixture versus hyaluronic acid and platelet rich plasma mixture after arthrocentesis in anterior disc displacement with reduction
Time frame: 3 months
measuring maximum mouth opening using caliper to determine the opening in mm
1 secondary outcome
Evaluation of the efficacy of intra-articular injection of hyaluronic acid and corticosteroids mixture versus hyaluronic acid and platelet rich plasma mixture after arthrocentesis in anterior disc displacement with reduction
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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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.
Mohamed Ashraf Eissa, Assisstant professor principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthrocentesis with ringer solution in people with Internal Derangement, 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 5 inclusion and 3 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: opening soon, as of the sponsor's last update on 22 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Omar Hamdy Negm, BDS Oral and dental medicine (+20 1002006335, omarhamdynegm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the efficacy of intra-articular injection of hyaluronic acid and corticosteroids mixture versus hyaluronic acid and platelet rich plasma mixture after arthrocentesis in anterior disc displacement with reduction (time frame: 3 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 22 May 2026.