Temporomandibular Joint Internal DerangementPhase 1/2NCT06572904
Effect of Intraarticular Injection of Tenoxicam and Hyaluronic Acid Versus Platelet-Rich Plasma and Hyaluronic Acid in Temporomandibular Joint Internal Derangement
A Phase 1/2 study testing Tenoxicam Injectable Product and Hyaluronic Acid 20 MG/1 ML Injection Gel/Jelly in people with Temporomandibular Joint Internal Derangement, run by Mansoura University at 1 site in Egypt.
Trial summary
To compare the effect of intraarticular injection of Tenoxicam and Hyaluronic acid Versus Platelet-rich plasma and Hyaluronic acid in the management of patients with TMJ internal derangement with reduction. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Temporomandibular Joint Internal Derangement
- What is being tested?
- Tenoxicam Injectable Product and Hyaluronic Acid 20 MG/1 ML Injection Gel/Jelly
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2024to 20 Nov 2024
- Phase
- Phase 1/2
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients age must be (18 -45).
- Patients have painful joint, clicking sound, with or without limited mouth opening.
- patients are unresponsive to conservative treatment.
- Patient's ability and desire to complete the treatment protocol and follow-up visits.
- Patients with internal derangement with reduction confirmed by MRI imaging.
Who cannot join
- Patient with an inflammatory or connective tissue disease
- Patient with previous invasive TMJ surgical procedure.
- Neurologic disorders
- History of injection of any substance into the target TMJ during previous 6 months.
- History of drug allergy.
- Patient with a history of bony or fibrous adhesion.
Show all 10Show fewer
- Malignant disease in the head and neck region.
- TMJ Internal derangement without reduction.
- Patients respond to conservative treatment. 10.Patient with a psychological problem
- 11.Patients having gross mechanical restrictions and condylar fracture
Trial locations and contacts
1 site in 1 country.
About this study
To compare the effect of intraarticular injection of Tenoxicam and Hyaluronic acid Versus Platelet-rich plasma and Hyaluronic acid in the management of patients with TMJ internal derangement with reduction.
Read the detailed description
The temporomandibular joint (TMJ) is a bilateral synovial joint located on both sides of the craniomandibular complex, which is involved in chewing, swallowing, speech, and other automatic movements such as yawning, grinding, or clenching; therefore, resting the joint is challenging under normal physiological conditions, except for clamping.Consequently, TMJ pathophysiology significantly impacts individuals' ability to perform basic daily life activities and vital functions.
Temporomandibular disorders (TMDs) are characterized by several symptoms, such as pain or tiredness in the muscles of the face, soreness in the orofacial region, tenderness in the muscles, restricted jaw motion, noise at the joint, hindered jaw function, alteration or diversion, rigidity, soreness, and locking brought on by muscle spasm. TMD may also be accompanied by other neurological symptoms such as headaches, vertigo, heaviness, and impaired vision.
Pain, clicking, a misaligned jaw, and restricted jaw movement are typical symptoms of TMJ ID. The incidence of TMJ pain is shown to affect 9-15% of women and 3-10% of males in the adult population, The disease more frequently affects young persons as opposed to the degenerative lesions of the major joints, This makes TMD a significant social issue that has an impact on people\'s quality of life.
The primary goal of TMJID treatment is to alleviate pain, restore mandibular functions (mastication and speech), and enhance quality of life.Different therapies, including conservative treatment, minimally invasive surgical operations, and invasive surgical operations, have been widely tested to treat TMD.
Various non-surgical approaches, such as reassurance, physiotherapy, pharmacotherapy, and occlusal splint treatment, have been used to treat TMJID. Minimally invasive treatment approaches for TMJID- include arthrocentesis and intra-articular injections.
Tenoxicam (TX) is a NSAID that is used systemically or locally in joint diseases such as acute or chronic inflammatory rheumatoid arthritis and osteoarthritis.It has been reported that its long-lasting analgesic and anti-inflammatory effects are higher in intra-articular administration than in oral and intravenous administrations. However, there are few studies on intra-articular injection of tenoxicam in patients with temporomandibular joint disc displacements.
Hyaluronic acid (HA) is a high molecular-weight (high-MW) glycosaminoglycan natural synovial fluid and shares in joint lubrication.HA injections have been widely used in the management of TMJDs, and several studies showed promising results in the improvement of maximum inter-incisal opening (MIO) and pain reduction.
The viscosupplementation concept describes the physical mechanism of action mostly carried out by high-MW HAs and by- products. It is based on modifications to HA molecules to promote elasto-viscosity. While the viscoinduction effect of low MW HA, which results in therapeutic benefits after intra-articular Injection, illustrates the underlying process. As a result, the HA-based formulations recommended for the intra-articular treatment of TMJD may differ from one another.
Platelet-rich plasma (PRP) popularly considered as PRP is a concentration of platelets and related growth factors that may have therapeutic effects by attracting, promoting, and differentiating cells as well as remodeling tissue.PRP increases chondrogenic proliferation and the production of matrix molecules, which facilitates joint movement and preserves the chondral surface\'s overall structure.
HA and PRP mixture were used in many studies treating TMJ or other joints osteoarthritis, PRP restores intra-articular HA, increases glycosaminoglycan chondrocyte synthesis, balances joint angiogenesis, and provides a scaffold for stem cell migration.
To the best of our knowledge, no study up to date has compared the effect of intra-articular injection of a mixture of Tenoxicam and Hyaluronic acid. So, the purpose of this study will be to compare the effect of intra- articular injection of a mixture of (TX and HA) versus (PRP and HA) in the management of patients with TMJ internal derangement with reduction.
- Being tested
- Tenoxicam Injectable Product, Hyaluronic Acid 20 MG/1 ML Injection Gel/Jelly
- Keywords
- Tenoxicam, ID, PRP, TMD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenoxicam Injectable ProductDrug
(EPICOTIL® Tenoxicam 20 mg , Manufactured by: EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY, ReStore at a temperature not exceeding 30°C.)
Hyaluronic Acid 20 MG/1 ML Injection Gel/JellyDrug
- (Hyalubrix® hyaluronic acid sodium salt 30 MG/2 ML, manufactured by Fidia SPA,Italy, stored at temperature > 25 °C)
| Study group | Role | What they receive |
|---|---|---|
| patients will receive a mixture of tenoxicam and HA. | Experimental | The injection point will be marked Patients will be instructed to open their mouths widely and maintain the mandible in a protruded position A mixture of 1mm of TX and 1ml of HA will be slowly injected intra-articular at the point of entry. Receives: Drug: Tenoxicam Injectable Product; Drug: Hyaluronic Acid 20 MG/1 ML Injection Gel/Jelly |
| patients will receive a mixture of PRP and HA. | Experimental | 10 ml of the patient's blood from the ulnar vein into a sterile glass tube containing sodium citrate as an anticoagulant. After mixing the blood with the citrate, using rotating movements, the tubes will be centrifuged at 1500 rpm for 6 min.The injection point will be marked Patients will be instructed to open their mouths widely and maintain the mandible in a protruded position mixture of 1-ml of PRP and 1-ml of HA will be slowly injected intra-articular at the point of entry. Receives: Drug: Hyaluronic Acid 20 MG/1 ML Injection Gel/Jelly |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracapsular Pain and pain during movement
Pain intensity will be measured by VAS score. Zero score for no pain and 10 score for worst pain experienced
Measured: at 1 week, 4, 12, and 24 weeks
Clicking sound
Clicking sound will be assessed as to its presence = 1 or absence =0.
Measured: at 1 week, 4, 12, and 24 weeks
Maximum inter-incisal opening (MIO)
Maximum inter-incisal opening (MIO): was measured by Vernier caliper as the vertical distance in millimeters between the maxillary and mandibular incisal edges of the central incisors.
Measured: at 1 week, 4, 12, and 24 weeks
Secondary outcomes (1)
Magnetic Resonance Imaging (MRI) evaluation
Magnetic resonance imaging (MRI) (open and closed) will be done for all patients to diagnose the patients with internal derangement with reduction The MRI protocol included bilateral sagittal oblique proton-density images of the right and left sides in both the closed-mouth (maximum intercuspation) and maximum mouth opening positions.
Measured: will be done at 24 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start20 Feb 2024
- Primary completion20 Oct 2024 (estimated)
- Study completion20 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Joint Internal DerangementStudies of the same condition, open and under way.
- More trials run by Mansoura 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 1/2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sally Awad, Prof, Principal investigator, Professor of Oral and Maxillofacial Surgery Faculty of Dentistry - Mansoura UniversityAmira Attia, Dr, Study director, Lecturer of Oral and Maxillofacial Surgery Faculty of Dentistry- Mansoura UniversityManar Mansour, Dr, Study director, Lecturer of Diagnostic and Interventional Radiology Faculty of Medicine- Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06572904
- Sponsor's protocol ID
- TMJ ID
- Status last verified
- Aug 2024
- First submitted
- 23 Aug 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lomas J, Gurgenci T, Jackson C, Campbell D. Temporomandibular dysfunction. Aust J Gen Pract. 2018 Apr;47(4):212-215. doi: 10.31128/AFP-10-17-4375.
PubMed 29621862Ingawale S, Goswami T. Temporomandibular joint: disorders, treatments, and biomechanics. Ann Biomed Eng. 2009 May;37(5):976-96. doi: 10.1007/s10439-009-9659-4. Epub 2009 Feb 28.
PubMed 19252985Gencer ZK, Ozkiris M, Okur A, Korkmaz M, Saydam L. A comparative study on the impact of intra-articular injections of hyaluronic acid, tenoxicam and betametazon on the relief of temporomandibular joint disorder complaints. J Craniomaxillofac Surg. 2014 Oct;42(7):1117-21. doi: 10.1016/j.jcms.2014.01.041. Epub 2014 Feb 4.
PubMed 24853591Al-Delayme RMA, Alnuamy SH, Hamid FT, Azzamily TJ, Ismaeel SA, Sammir R, Hadeel M, Nabeel J, Shwan R, Alfalahi SJ, Yasin A. The Efficacy of Platelets Rich Plasma Injection in the Superior Joint Space of the Tempromandibular Joint Guided by Ultra Sound in Patients with Non-reducing Disk Displacement. J Maxillofac Oral Surg. 2017 Mar;16(1):43-47. doi: 10.1007/s12663-016-0911-9. Epub 2016 Jun 10.
PubMed 28286383Nitzan DW, Dolwick MF, Martinez GA. Temporomandibular joint arthrocentesis: a simplified treatment for severe, limited mouth opening. J Oral Maxillofac Surg. 1991 Nov;49(11):1163-7; discussion 1168-70. doi: 10.1016/0278-2391(91)90409-f.
PubMed 1941330Israel HA. Internal Derangement of the Temporomandibular Joint: New Perspectives on an Old Problem. Oral Maxillofac Surg Clin North Am. 2016 Aug;28(3):313-33. doi: 10.1016/j.coms.2016.03.009.
PubMed 27475509Xu J, Ren H, Zhao S, Li Q, Li C, Bao G, Kang H. Comparative effectiveness of hyaluronic acid, platelet-rich plasma, and platelet-rich fibrin in treating temporomandibular disorders: a systematic review and network meta-analysis. Head Face Med. 2023 Aug 26;19(1):39. doi: 10.1186/s13005-023-00369-y.
PubMed 37633896Sousa BM, Lopez-Valverde N, Lopez-Valverde A, Caramelo F, Fraile JF, Payo JH, Rodrigues MJ. Different Treatments in Patients with Temporomandibular Joint Disorders: A Comparative Randomized Study. Medicina (Kaunas). 2020 Mar 5;56(3):113. doi: 10.3390/medicina56030113.
PubMed 32151101Attia AAMM, Awad SS. Hyaluronic Acid and Platelet-Rich Plasma Mixture Versus Hyaluronic Acid and Corticosteroid in the Treatment of Temporomandibular Joint Internal Derangement: A Comparative Randomized Study. J Maxillofac Oral Surg. 2023 Apr 5;23(2):1-7. doi: 10.1007/s12663-023-01907-6. Online ahead of print.
PubMed 37362881Mountziaris PM, Kramer PR, Mikos AG. Emerging intra-articular drug delivery systems for the temporomandibular joint. Methods. 2009 Feb;47(2):134-40. doi: 10.1016/j.ymeth.2008.09.001. Epub 2008 Oct 1.
PubMed 18835358Hosgor H. Is arthrocentesis plus hyaluronic acid superior to arthrocentesis alone in the treatment of disc displacement without reduction in patients with bruxism? J Craniomaxillofac Surg. 2020 Nov;48(11):1023-1027. doi: 10.1016/j.jcms.2020.07.008. Epub 2020 Jul 25.
PubMed 33028488Danieli MV, Cavazzani Neto A, Herrera PA. Intra-articular bupivacaine or bupivacaine and morphine after ACL reconstruction. Acta Ortop Bras. 2012;20(5):258-61. doi: 10.1590/S1413-78522012000500002.
PubMed 24453613Talu GK, Ozyalcin S, Koltka K, Erturk E, Akinci O, Asik M, Pembeci K. Comparison of efficacy of intraarticular application of tenoxicam, bupivacaine and tenoxicam: bupivacaine combination in arthroscopic knee surgery. Knee Surg Sports Traumatol Arthrosc. 2002 Nov;10(6):355-60. doi: 10.1007/s00167-002-0306-y. Epub 2002 Aug 7.
PubMed 12444514Bayramoglu Z, Yavuz GY, Keskinruzgar A, Koparal M, Kaya GS. Does intra-articular injection of tenoxicam after arthrocentesis heal outcomes of temporomandibular joint osteoarthritis? A randomized clinical trial. BMC Oral Health. 2023 Mar 8;23(1):131. doi: 10.1186/s12903-023-02852-z.
PubMed 36890529Gigante A, Callegari L. The role of intra-articular hyaluronan (Sinovial) in the treatment of osteoarthritis. Rheumatol Int. 2011 Apr;31(4):427-44. doi: 10.1007/s00296-010-1660-6. Epub 2010 Nov 28.
PubMed 21113807
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraarticular Injection of Tenoxicam and Hyaluronic Acid Versus Platelet-Rich Plasma and Hyaluronic Acid in Temporomandibular Joint Internal Derangement
- ClinicalTrials.gov ID
- NCT06572904
- Acronym / sponsor ID
- TMJ ID
- Keywords
- Tenoxicam, ID, PRP, TMD
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 20 Oct 2024 (estimated)
- Study completion
- 20 Nov 2024 (estimated)
- First posted
- 27 Aug 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.
To compare the effect of intraarticular injection of Tenoxicam and Hyaluronic acid Versus Platelet-rich plasma and Hyaluronic acid in the management of patients with TMJ internal derangement with reduction.
Detailed description
The temporomandibular joint (TMJ) is a bilateral synovial joint located on both sides of the craniomandibular complex, which is involved in chewing, swallowing, speech, and other automatic movements such as yawning, grinding, or clenching; therefore, resting the joint is challenging under normal physiological conditions, except for clamping.Consequently, TMJ pathophysiology significantly impacts individuals' ability to perform basic daily life activities and vital functions.
Temporomandibular disorders (TMDs) are characterized by several symptoms, such as pain or tiredness in the muscles of the face, soreness in the orofacial region, tenderness in the muscles, restricted jaw motion, noise at the joint, hindered jaw function, alteration or diversion, rigidity, soreness, and locking brought on by muscle spasm. TMD may also be accompanied by other neurological symptoms such as headaches, vertigo, heaviness, and impaired vision.
Pain, clicking, a misaligned jaw, and restricted jaw movement are typical symptoms of TMJ ID. The incidence of TMJ pain is shown to affect 9-15% of women and 3-10% of males in the adult population, The disease more frequently affects young persons as opposed to the degenerative lesions of the major joints, This makes TMD a significant social issue that has an impact on people\'s quality of life.
The primary goal of TMJID treatment is to alleviate pain, restore mandibular functions (mastication and speech), and enhance quality of life.Different therapies, including conservative treatment, minimally invasive surgical operations, and invasive surgical operations, have been widely tested to treat TMD.
Various non-surgical approaches, such as reassurance, physiotherapy, pharmacotherapy, and occlusal splint treatment, have been used to treat TMJID. Minimally invasive treatment approaches for TMJID- include arthrocentesis and intra-articular injections.
Tenoxicam (TX) is a NSAID that is used systemically or locally in joint diseases such as acute or chronic inflammatory rheumatoid arthritis and osteoarthritis.It has been reported that its long-lasting analgesic and anti-inflammatory effects are higher in intra-articular administration than in oral and intravenous administrations. However, there are few studies on intra-articular injection of tenoxicam in patients with temporomandibular joint disc displacements.
Hyaluronic acid (HA) is a high molecular-weight (high-MW) glycosaminoglycan natural synovial fluid and shares in joint lubrication.HA injections have been widely used in the management of TMJDs, and several studies showed promising results in the improvement of maximum inter-incisal opening (MIO) and pain reduction.
The viscosupplementation concept describes the physical mechanism of action mostly carried out by high-MW HAs and by- products. It is based on modifications to HA molecules to promote elasto-viscosity. While the viscoinduction effect of low MW HA, which results in therapeutic benefits after intra-articular Injection, illustrates the underlying process. As a result, the HA-based formulations recommended for the intra-articular treatment of TMJD may differ from one another.
Platelet-rich plasma (PRP) popularly considered as PRP is a concentration of platelets and related growth factors that may have therapeutic effects by attracting, promoting, and differentiating cells as well as remodeling tissue.PRP increases chondrogenic proliferation and the production of matrix molecules, which facilitates joint movement and preserves the chondral surface\'s overall structure.
HA and PRP mixture were used in many studies treating TMJ or other joints osteoarthritis, PRP restores intra-articular HA, increases glycosaminoglycan chondrocyte synthesis, balances joint angiogenesis, and provides a scaffold for stem cell migration.
To the best of our knowledge, no study up to date has compared the effect of intra-articular injection of a mixture of Tenoxicam and Hyaluronic acid. So, the purpose of this study will be to compare the effect of intra- articular injection of a mixture of (TX and HA) versus (PRP and HA) in the management of patients with TMJ internal derangement with reduction.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients will receive a mixture of tenoxicam and HA. | Experimental | Drug: Tenoxicam Injectable Product, Drug: Hyaluronic Acid 20 MG/1 ML Injection Gel/JellyThe injection point will be marked Patients will be instructed to open their mouths widely and maintain the mandible in a protruded position A mixture of 1mm of TX and 1ml of HA will be slowly injected intra-articular at the point of entry. |
| patients will receive a mixture of PRP and HA. | Experimental | Drug: Hyaluronic Acid 20 MG/1 ML Injection Gel/Jelly10 ml of the patient's blood from the ulnar vein into a sterile glass tube containing sodium citrate as an anticoagulant. After mixing the blood with the citrate, using rotating movements, the tubes will be centrifuged at 1500 rpm for 6 min.The injection point will be marked Patients will be instructed to open their mouths widely and maintain the mandible in a protruded position mixture of 1-ml of PRP and 1-ml of HA will be slowly injected intra-articular at the point of entry. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients age must be (18 -45).
- Patients have painful joint, clicking sound, with or without limited mouth opening.
- patients are unresponsive to conservative treatment.
- Patient's ability and desire to complete the treatment protocol and follow-up visits.
- Patients with internal derangement with reduction confirmed by MRI imaging.
Key exclusion criteria (10 listed)
- Patient with an inflammatory or connective tissue disease
- Patient with previous invasive TMJ surgical procedure.
- Neurologic disorders
- History of injection of any substance into the target TMJ during previous 6 months.
- History of drug allergy.
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 |
|---|---|---|
| Tenoxicam Injectable Product(EPICOTIL® Tenoxicam 20 mg , Manufactured by: EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY, ReStore at a temperature not exceeding 30°C.) | Drug | patients will receive a mixture of tenoxicam and HA. |
| Hyaluronic Acid 20 MG/1 ML Injection Gel/Jelly* (Hyalubrix® hyaluronic acid sodium salt 30 MG/2 ML, manufactured by Fidia SPA,Italy, stored at temperature > 25 °C) | Drug | patients will receive a mixture of PRP and HA., patients will receive a mixture of tenoxicam and HA. |
Primary outcome
Intracapsular Pain and pain during movement
Time frame: at 1 week, 4, 12, and 24 weeks
Pain intensity will be measured by VAS score. Zero score for no pain and 10 score for worst pain experienced
Clicking sound
Time frame: at 1 week, 4, 12, and 24 weeks
Clicking sound will be assessed as to its presence = 1 or absence =0.
Maximum inter-incisal opening (MIO)
Time frame: at 1 week, 4, 12, and 24 weeks
Maximum inter-incisal opening (MIO): was measured by Vernier caliper as the vertical distance in millimeters between the maxillary and mandibular incisal edges of the central incisors.
1 secondary outcome
Magnetic Resonance Imaging (MRI) evaluation
Time frame: will be done at 24 weeks postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Background: PubMed 29621862Lomas J, Gurgenci T, Jackson C, Campbell D. Temporomandibular dysfunction. Aust J Gen Pract. 2018 Apr;47(4):212-215. doi: 10.31128/AFP-10-17-4375.
- Background: PubMed 19252985Ingawale S, Goswami T. Temporomandibular joint: disorders, treatments, and biomechanics. Ann Biomed Eng. 2009 May;37(5):976-96. doi: 10.1007/s10439-009-9659-4. Epub 2009 Feb 28.
- Background: PubMed 24853591Gencer ZK, Ozkiris M, Okur A, Korkmaz M, Saydam L. A comparative study on the impact of intra-articular injections of hyaluronic acid, tenoxicam and betametazon on the relief of temporomandibular joint disorder complaints. J Craniomaxillofac Surg. 2014 Oct;42(7):1117-21. doi: 10.1016/j.jcms.2014.01.041. Epub 2014 Feb 4.
- Background: PubMed 28286383Al-Delayme RMA, Alnuamy SH, Hamid FT, Azzamily TJ, Ismaeel SA, Sammir R, Hadeel M, Nabeel J, Shwan R, Alfalahi SJ, Yasin A. The Efficacy of Platelets Rich Plasma Injection in the Superior Joint Space of the Tempromandibular Joint Guided by Ultra Sound in Patients with Non-reducing Disk Displacement. J Maxillofac Oral Surg. 2017 Mar;16(1):43-47. doi: 10.1007/s12663-016-0911-9. Epub 2016 Jun 10.
- Background: PubMed 1941330Nitzan DW, Dolwick MF, Martinez GA. Temporomandibular joint arthrocentesis: a simplified treatment for severe, limited mouth opening. J Oral Maxillofac Surg. 1991 Nov;49(11):1163-7; discussion 1168-70. doi: 10.1016/0278-2391(91)90409-f.
- Background: PubMed 27475509Israel HA. Internal Derangement of the Temporomandibular Joint: New Perspectives on an Old Problem. Oral Maxillofac Surg Clin North Am. 2016 Aug;28(3):313-33. doi: 10.1016/j.coms.2016.03.009.
- Background: PubMed 37633896Xu J, Ren H, Zhao S, Li Q, Li C, Bao G, Kang H. Comparative effectiveness of hyaluronic acid, platelet-rich plasma, and platelet-rich fibrin in treating temporomandibular disorders: a systematic review and network meta-analysis. Head Face Med. 2023 Aug 26;19(1):39. doi: 10.1186/s13005-023-00369-y.
- Background: PubMed 32151101Sousa BM, Lopez-Valverde N, Lopez-Valverde A, Caramelo F, Fraile JF, Payo JH, Rodrigues MJ. Different Treatments in Patients with Temporomandibular Joint Disorders: A Comparative Randomized Study. Medicina (Kaunas). 2020 Mar 5;56(3):113. doi: 10.3390/medicina56030113.
- Background: PubMed 37362881Attia AAMM, Awad SS. Hyaluronic Acid and Platelet-Rich Plasma Mixture Versus Hyaluronic Acid and Corticosteroid in the Treatment of Temporomandibular Joint Internal Derangement: A Comparative Randomized Study. J Maxillofac Oral Surg. 2023 Apr 5;23(2):1-7. doi: 10.1007/s12663-023-01907-6. Online ahead of print.
- Background: PubMed 18835358Mountziaris PM, Kramer PR, Mikos AG. Emerging intra-articular drug delivery systems for the temporomandibular joint. Methods. 2009 Feb;47(2):134-40. doi: 10.1016/j.ymeth.2008.09.001. Epub 2008 Oct 1.
- Background: PubMed 33028488Hosgor H. Is arthrocentesis plus hyaluronic acid superior to arthrocentesis alone in the treatment of disc displacement without reduction in patients with bruxism? J Craniomaxillofac Surg. 2020 Nov;48(11):1023-1027. doi: 10.1016/j.jcms.2020.07.008. Epub 2020 Jul 25.
- Background: PubMed 24453613Danieli MV, Cavazzani Neto A, Herrera PA. Intra-articular bupivacaine or bupivacaine and morphine after ACL reconstruction. Acta Ortop Bras. 2012;20(5):258-61. doi: 10.1590/S1413-78522012000500002.
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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.
Sally Awad, Prof principal investigator
Professor of Oral and Maxillofacial Surgery Faculty of Dentistry - Mansoura University
Amira Attia, Dr study director
Lecturer of Oral and Maxillofacial Surgery Faculty of Dentistry- Mansoura University
Manar Mansour, Dr study director
Lecturer of Diagnostic and Interventional Radiology Faculty of Medicine- Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Tenoxicam Injectable Product and Hyaluronic Acid 20 MG/1 ML Injection Gel/Jelly in people with Temporomandibular Joint Internal Derangement, run by Mansoura 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 10 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 27 Aug 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 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intracapsular Pain and pain during movement (time frame: at 1 week, 4, 12, and 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06572904, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.