Temporomandibular Joint Internal DerangementPhase 3NCT07789860
Efficacy of Injectable PRF in Management of TMJ Internal Derangement
A Phase 3 study testing TMJ arthrocentesis, Autologous platelet rich fibrin ( injectable PRF) and Hyaluronic acid gel (HA) in people with Temporomandibular Joint Internal Derangement, run by Suez Canal University at 1 site in Egypt.
Trial summary
This study evaluated the efficacy of injectable platelet-rich fibrin both clinically and using MRI in management of temporomandibular joint internal derangement Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Temporomandibular Joint Internal Derangement
- What is being tested?
- TMJ arthrocentesis, Autologous platelet rich fibrin ( injectable PRF) and Hyaluronic acid gel (HA)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Sep 2023to 30 Oct 2024
- Phase
- Phase 3
- 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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients with TMJ disc displacement with or without reduction between 18-55years old
- Patients unresponsive to conservative treatment of TMD
- Patients with limited mouth opening, painful clicking
- Pain elicited with joint function
Who cannot join
- 1) Myofacial pain dysfunction syndrome MPDS 2) Patients underwent previous TMJ arthrocentesis, arthroscopy or surgery 3) Pregnancy 4) Patients with systemic diseases that impair soft or hard tissue healing 5)Patients with total joint replacement 6) uncooperative patients, those who wouldn't stick to the follow up periods. 7) hysteric and needle phobic patients ( GA is preferred over Local anesthesia in this situation).
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry Suez canal university
Ismailia, Ismailia Governorate, 41516
About this study
Official title: Clinical and Radiographic Evaluation of the Efficacy of Injectable PRF(Platelet-rich Fibrin ) in Management of Temporomandibular Joint Internal Derangement: a Randomised Controlled Clinical Study
This study evaluated the efficacy of injectable platelet-rich fibrin both clinically and using MRI in management of temporomandibular joint internal derangement
Read the detailed description
Temporomandibular disorders (TMD) are a significant public health problem affecting approximately 5-12% of the overall population and are considered the most common cause of chronic pain of non-dental origin in the orofacial region(Hegab et al2021) The internal derangements (IDs) are considered as the most common non- inflammatory disorders of the TMJ, since they affect about 10% of the population worldwide and represent approximately 41.1% of all temporomandibular disorders. The term "internal derangement" refers to abnormal pathways during the functional movement of the TMJ that mostly involves the articular disc function, how ever, IDs could be observed even in asymptomatic individuals (Ghonim et al 2022) joint osteoarthritis (TMJ OA) is a common disorder among the population, is more prevalent in females than in males, and increases in prevalence with age.1 Me chanical and biological events including overloading, bruxism, and unilateral chewing, as well as genetics factor ( Co¨mert Kilic et al2016 ) The pathogenesis of this temporomandibular joint dysfunction has pointed to biochemical factors ,separate from the disc displacement theory .for example
,inflammatory reactions that occur in TMJ are essential for the development and progression of the disease ,including high levels o inflammatory mediators in the synovial fluid ,such as interleukin 1 beta ,tumor necrosis factor alpha and others
.furthermore, the disintegration of the important component of the synovial fluid, the hyaluronic acid (HA) ,leads to a decrease in viscosity of the synovial fluid and degeneration of the joint proteoglycans.(Mahmoud Hassan Toamah et al 2019)
Temporomandibular joint disorders include disk displacements, with or without reduction, that may be associated with inflammatory changes, such as capsulitis and retrodiscitis, or with degenerative changes, such as temporomandibular joint (TMJ) osteoarthritis and osteoarthrosis.3 Common symptoms include pain, which is aggravated by the mandibular movement, joints sounds (clicking or crepitus), a decrease in masticatory efficiency, and functional limitation in the mandibular movement(Harba, A. and Harfoush, M. 2021) . Injection of intra-articular medicaments is an accepted therapy for temporomandibular joint disorders (TMDs)( Jacob, S.M. et al. (2021) Arthrocentesis is minimally invasive technique , less expensive than surgical procedures and simple with low morbidity used for flushing the TMJ that is done by access to the upper joint compartment ( H.A.M.Marzook et al 2020). lavage helps remove the inflammatory mediators and cells . It is done when conservative treatment fails to treat the TMJ disorders using patient education physical therapy, or splints . at first it was done by saline or Ringers solution to just flush and lavage the joint but then corticosteroids were used to benefit from their anti inflammatory action . Hyaluronic acid is also used in arthrocentesis due to its lubricant effect, Platelet-rich plasma (PRP) is a biological therapy that comprises an autologous concentrate of platelets acquired by blood centrifugation [11]. This concentrate has shown potential benefits due to the abundance of growth factors within it(Abaddi et al 2022 )it has analgesic ,anti inflammatory and antibiotic effect ,helps restore intraarticular acidic acid and stimulates cartilage cells to produce Glycosaminoglycans, regulates the balance angiogenesis within the joint ,induces cell proliferation and cartilage production through cartilage cells ,increases the production of hyaluronic acid though synovial cells ,achieves high concentration of growth factors especially TGF-B[Mustafa Manafikhi et al 2022] but there is still a concern regarding the use of anticoagulants in preparation of PRP
Several studies were done to compare between HAand PRP in management of Temporomandibular joint disorders . Four of the studies found PRP injections to be superior in terms of improvements in mandibular range of motion and pain intensity up to 12 months after treatment, while the remaining two studies found similar results for the different treatments (Bousnaki M. et al 2018)
Two groups were included in the study ; the control group underwent arthrocentesis then injection of Hyaluronic acid gel whereas the study group underwent arthrocentesis then administration of injectable PRF
1-these patients were clinically examined and radiographically using MRI
II-Operative stage : this study was conducted under local anesthesia (LA).
- after disinfection of the operative field and injection of local anesthesia, a reference line was drawn from the outer canthus of the eye to the tragus of the ear [cantho- tragal line] .
- Double injection technique was used , the first point was marked along the the cantho -tragal line [Holmlund -Hellsing line] 2mm below the line and 10 mm in front of the tragus. The second point wasmarked 10 mm below the line and 20 mm from the tragus of the ear .
- control goup was managed by injection of Hyaluronic acid [HA] after lavage of the upper compartment space using saline solution
- the first needle [20 gauge] was inserted in to the first marked ,point 2 mm below the cantho-tragal line and 10 mm from the tragus of the ear .
- the patient was instructed to open protrusively ,20ml of ringer's solution was injected into the upper joint space then 100mm of ringer's solution was injected that flow back out of the upper joint space through the second needle[20 gauge ] that was inserted 20 mm from the tragus of the ear and 10 mm below the cantho-tragal line.
- then 2ml of HA was injected through the first needle while the second needle was removed. Throughout the whole procedure, the patient was instructed to open and close the mandible to facilitate the flow of the solution inside the joint .
- the study group ;arthrocentesis was done with the same steps as in the first group . the injectable platelet rich fibrin I- PRF was injected into the upper joint space. Injectable PRF was prepared immediately before arthrocentesis from centrifuging of blood taking from the ulnar vein in a tube without anticoagulants at 700 rpm for 3 minutes , after centrifuging it was separated from the blood hemocytes as I-PRF was collected on the top of the tube while the blood hemocytes being precipitated in the bottom of the tube , 2ml of I-PRF was collected then injected directly into the joint after arthrocentesis with ringers solution through the first needle .the mandible was manipulated in opening , closing and lateral movements to free the adhesion of the disc.
III-Post operative stage :
the patients in both groups were instructed to have soft diet, heat fomentation over the TMJ area and keep moving the mandible.
Analgesics and antibiotics were prescribed to avoid un necessary complications of infection.
- Being tested
- TMJ arthrocentesis, Autologous platelet rich fibrin ( injectable PRF), Hyaluronic acid gel (HA)
- Keywords
- Injectable PRF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMJ arthrocentesisProcedure or surgery
Joint arthrocentesis was done to wash out any inflammatory exudate that were detected clinically as joint swelling or as white dots in T2 MRI images. The two needle arthrocentesis technique was used under local anesthesia. Two points were marked along the canthotragal line; the first /posterior point was marked 10mm along the line and 2mm below it ( representative of the glenoid fossa) whereas the second/ anterior point was marked 20mm along the line and 10mm below it( representative of the articular eminence). The first needle was inserted first and about 20ml of ringer's solution was injected to distend the joint capsule then the second needle was inserted and about 100ml of ringer's solution was injected. Throughout the whole procedure, the patients were asked to open, close and protrude their jaw and move their jaw laterally to help the fluid diffuse through the joint and release any adhesions.
Autologous platelet rich fibrin ( injectable PRF)Biological
Single intraarticular administration of 2ml of injectable PRF immediately after TMJ arthrocentesis. Injectable PRF was prepared immediately before arthrocentesis from centrifuging (TD4 centrifuge, Hunan Lab we scientific instruments, China) of blood taking from the ulnar vein in a plain glass coated tube without anticoagulants at 700 rpm for 3 minutes , after centrifuging it was separated from the blood hemocytes as I-PRF was collected on the top of the tube while the blood hemocytes was precipitated in the bottom of the tube , 2ml of I-PRF was collected then injected directly into the joint after arthrocentesis with ringers solution through the first needle.
Hyaluronic acid gel (HA)Device
A single intraarticular administration of 2ml of low molecular weight Hyaluronic acid gel ( Hyalgan, hyaluronic acid sodium salt, Fidia pharmaceuticals, Italy) immediately after joint arthrocentesis.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm ( TMJ arthrocentesis then administration of injectable PRF) | Experimental | Patients with TMJ internal derangement (disc displacement with \& without reduction) underwent TMJ arthrocentesis then immediate administration of autologous injectable PRF (platelet-rich fibrin) Receives: Procedure: TMJ arthrocentesis; Biological: Autologous platelet rich fibrin ( injectable PRF) |
| Active comparator arm ( TMJ arthrocentesis then administration of Hyaluronic acid gel) | Active comparator | Patients with TMJ internal derangement ( disc displacement with and without reduction) underwent TMJ arthrocentesis then intraarticular injection of Hyaluronic acid gel Receives: Procedure: TMJ arthrocentesis; Device: Hyaluronic acid gel (HA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum mouth opening MMO
Maximum mouth opening was measured for each patients preoperatively using a ruler in millimeters. patients with limited mouth opening ( normal mouth opening equals Three fingers of the patients inserted as one column between the upper and lower central incisors or 42.6 ± 5.6 mm).
Measured: Patients were scheduled for follow up periods at 1 week, 1 month, 3 months and 6 months.
temporomandibular joint pain
Patients reported joint pain were assessed via Visual Analogue Scale VAS , where 0 represents no pain and 10 represents severe pain.
Measured: Patients were scheduled for follow up periods at 1 week, 1 month , 3 months and 6 months postoperatively
Secondary outcomes (3)
Temporomandibular joint clicking
Assessment of presence of joint clicking was done via auscultation using a stethoscope, categorised binary as present or absent.
Measured: These patients were scheduled for follow up periods at 1 week, 1 month,3 months and 6 months postoperatively.
Temporomandibular joint disc position
Any change in the previously displaced joint disc to the normal articulation with the condyle was assessed by comparing 2 MRIs, one taken at the phase of clinical examination and the other taken after 6 months postoperatively.
It was measured as normal alignment or displacement.
Measured: Preoperatively and 6 months postoperatively.
Temporomandibular joint effusion
It was assessed as presence or absence of high signal intensity within the joint space detected on T2 MRI image.
Measured: Preoperatively and 6 months 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 2026
- Study start30 Sep 2023
- Primary completion20 Sep 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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 Suez Canal 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A comparative, randomised controlled prospective study was conducted to evaluate the efficacy of injectable PRF in management of temporomandibular joint internal derangement in terms of maximum mouth opening,joint pain and clicking. These parameters were evaluated at 1month,3 months and 6 months postoperatively both clinically and using MRI.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed A. El sholkamy, Professor of surgery, Study chair, Department of oral and maxillofacial surgery, faculty of Dentistry Suez canal university ,Ismailia,Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07789860
- Sponsor's protocol ID
- Injectable PRF in TMD
- Status last verified
- Jul 2026
- First submitted
- 4 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Toameh MH, Alkhouri I, Karman MA. Management of patients with disk displacement without reduction of the temporomandibular joint by arthrocentesis alone, plus hyaluronic acid or plus platelet-rich plasma. Dent Med Probl. 2019 Jul-Sep;56(3):265-272. doi: 10.17219/dmp/109329.
PubMed 31577070Manafikhi M, Ataya J, Heshmeh O. Evaluation of the efficacy of platelet rich fibrin (I-PRF) intra-articular injections in the management of internal derangements of temporomandibular joints - a controlled preliminary prospective clinical study. BMC Musculoskelet Disord. 2022 May 14;23(1):454. doi: 10.1186/s12891-022-05421-7.
PubMed 35568935Jacob SM, Bandyopadhyay TK, Chattopadhyay PK, Parihar VS. Efficacy of Platelet-Rich Plasma Versus Hyaluronic Acid Following Arthrocentesis for Temporomandibular Joint Disc Disorders: A Randomized Controlled Trial. J Maxillofac Oral Surg. 2022 Dec;21(4):1199-1204. doi: 10.1007/s12663-021-01519-y. Epub 2021 Feb 8.
PubMed 36896087Hegab AF, Hameed HIAA, Hassaneen AM, Hyder A. Synergistic effect of platelet rich plasma with hyaluronic acid injection following arthrocentesis to reduce pain and improve function in TMJ osteoarthritis. J Stomatol Oral Maxillofac Surg. 2023 Feb;124(1S):101340. doi: 10.1016/j.jormas.2022.11.016. Epub 2022 Nov 19.
PubMed 36414172Harba AN, Harfoush M. Evaluation of the participation of hyaluronic acid with platelet-rich plasma in the treatment of temporomandibular joint disorders. Dent Med Probl. 2021 Jan-Mar;58(1):81-88. doi: 10.17219/dmp/127446.
PubMed 33847473Ghoneim NI, Mansour NA, Elmaghraby SA, Abdelsameaa SE. Treatment of temporomandibular joint disc displacement using arthrocentesis combined with injectable platelet rich fibrin versus arthrocentesis alone. J Dent Sci. 2022 Jan;17(1):468-475. doi: 10.1016/j.jds.2021.07.027. Epub 2021 Aug 21.
PubMed 35028072Comert Kilic S, Gungormus M. Is arthrocentesis plus platelet-rich plasma superior to arthrocentesis plus hyaluronic acid for the treatment of temporomandibular joint osteoarthritis: a randomized clinical trial. Int J Oral Maxillofac Surg. 2016 Dec;45(12):1538-1544. doi: 10.1016/j.ijom.2016.06.009. Epub 2016 Jun 28.
PubMed 27364372Charan J, Biswas T. How to calculate sample size for different study designs in medical research? Indian J Psychol Med. 2013 Apr;35(2):121-6. doi: 10.4103/0253-7176.116232.
PubMed 24049221Bousnaki M, Bakopoulou A, Koidis P. Platelet-rich plasma for the therapeutic management of temporomandibular joint disorders: a systematic review. Int J Oral Maxillofac Surg. 2018 Feb;47(2):188-198. doi: 10.1016/j.ijom.2017.09.014. Epub 2017 Oct 20.
PubMed 29066000Abbadi W, Kara Beit Z, Al-Khanati NM. Arthrocentesis, Injectable Platelet-Rich Plasma and Combination of Both Protocols of Temporomandibular Joint Disorders Management: A Single-Blinded Randomized Clinical Trial. Cureus. 2022 Nov 11;14(11):e31396. doi: 10.7759/cureus.31396. eCollection 2022 Nov.
PubMed 36523721
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of the Efficacy of Injectable PRF(Platelet-rich Fibrin ) in Management of Temporomandibular Joint Internal Derangement: a Randomised Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT07789860
- Acronym / sponsor ID
- Injectable PRF in TMD
- Keywords
- Injectable PRF
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 30 Sep 2023 (actual)
- Primary completion
- 20 Sep 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 27 Aug 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.
This study evaluated the efficacy of injectable platelet-rich fibrin both clinically and using MRI in management of temporomandibular joint internal derangement
Detailed description
Temporomandibular disorders (TMD) are a significant public health problem affecting approximately 5-12% of the overall population and are considered the most common cause of chronic pain of non-dental origin in the orofacial region(Hegab et al2021) The internal derangements (IDs) are considered as the most common non- inflammatory disorders of the TMJ, since they affect about 10% of the population worldwide and represent approximately 41.1% of all temporomandibular disorders. The term "internal derangement" refers to abnormal pathways during the functional movement of the TMJ that mostly involves the articular disc function, how ever, IDs could be observed even in asymptomatic individuals (Ghonim et al 2022) joint osteoarthritis (TMJ OA) is a common disorder among the population, is more prevalent in females than in males, and increases in prevalence with age.1 Me chanical and biological events including overloading, bruxism, and unilateral chewing, as well as genetics factor ( Co¨mert Kilic et al2016 ) The pathogenesis of this temporomandibular joint dysfunction has pointed to biochemical factors ,separate from the disc displacement theory .for example
,inflammatory reactions that occur in TMJ are essential for the development and progression of the disease ,including high levels o inflammatory mediators in the synovial fluid ,such as interleukin 1 beta ,tumor necrosis factor alpha and others
.furthermore, the disintegration of the important component of the synovial fluid, the hyaluronic acid (HA) ,leads to a decrease in viscosity of the synovial fluid and degeneration of the joint proteoglycans.(Mahmoud Hassan Toamah et al 2019)
Temporomandibular joint disorders include disk displacements, with or without reduction, that may be associated with inflammatory changes, such as capsulitis and retrodiscitis, or with degenerative changes, such as temporomandibular joint (TMJ) osteoarthritis and osteoarthrosis.3 Common symptoms include pain, which is aggravated by the mandibular movement, joints sounds (clicking or crepitus), a decrease in masticatory efficiency, and functional limitation in the mandibular movement(Harba, A. and Harfoush, M. 2021) . Injection of intra-articular medicaments is an accepted therapy for temporomandibular joint disorders (TMDs)( Jacob, S.M. et al. (2021) Arthrocentesis is minimally invasive technique , less expensive than surgical procedures and simple with low morbidity used for flushing the TMJ that is done by access to the upper joint compartment ( H.A.M.Marzook et al 2020). lavage helps remove the inflammatory mediators and cells . It is done when conservative treatment fails to treat the TMJ disorders using patient education physical therapy, or splints . at first it was done by saline or Ringers solution to just flush and lavage the joint but then corticosteroids were used to benefit from their anti inflammatory action . Hyaluronic acid is also used in arthrocentesis due to its lubricant effect, Platelet-rich plasma (PRP) is a biological therapy that comprises an autologous concentrate of platelets acquired by blood centrifugation [11]. This concentrate has shown potential benefits due to the abundance of growth factors within it(Abaddi et al 2022 )it has analgesic ,anti inflammatory and antibiotic effect ,helps restore intraarticular acidic acid and stimulates cartilage cells to produce Glycosaminoglycans, regulates the balance angiogenesis within the joint ,induces cell proliferation and cartilage production through cartilage cells ,increases the production of hyaluronic acid though synovial cells ,achieves high concentration of growth factors especially TGF-B[Mustafa Manafikhi et al 2022] but there is still a concern regarding the use of anticoagulants in preparation of PRP
Several studies were done to compare between HAand PRP in management of Temporomandibular joint disorders . Four of the studies found PRP injections to be superior in terms of improvements in mandibular range of motion and pain intensity up to 12 months after treatment, while the remaining two studies found similar results for the different treatments (Bousnaki M. et al 2018)
Two groups were included in the study ; the control group underwent arthrocentesis then injection of Hyaluronic acid gel whereas the study group underwent arthrocentesis then administration of injectable PRF
1-these patients were clinically examined and radiographically using MRI
II-Operative stage : this study was conducted under local anesthesia (LA).
- after disinfection of the operative field and injection of local anesthesia, a reference line was drawn from the outer canthus of the eye to the tragus of the ear [cantho- tragal line] .
- Double injection technique was used , the first point was marked along the the cantho -tragal line [Holmlund -Hellsing line] 2mm below the line and 10 mm in front of the tragus. The second point wasmarked 10 mm below the line and 20 mm from the tragus of the ear .
- control goup was managed by injection of Hyaluronic acid [HA] after lavage of the upper compartment space using saline solution
- the first needle [20 gauge] was inserted in to the first marked ,point 2 mm below the cantho-tragal line and 10 mm from the tragus of the ear .
- the patient was instructed to open protrusively ,20ml of ringer's solution was injected into the upper joint space then 100mm of ringer's solution was injected that flow back out of the upper joint space through the second needle[20 gauge ] that was inserted 20 mm from the tragus of the ear and 10 mm below the cantho-tragal line.
- then 2ml of HA was injected through the first needle while the second needle was removed. Throughout the whole procedure, the patient was instructed to open and close the mandible to facilitate the flow of the solution inside the joint .
- the study group ;arthrocentesis was done with the same steps as in the first group . the injectable platelet rich fibrin I- PRF was injected into the upper joint space. Injectable PRF was prepared immediately before arthrocentesis from centrifuging of blood taking from the ulnar vein in a tube without anticoagulants at 700 rpm for 3 minutes , after centrifuging it was separated from the blood hemocytes as I-PRF was collected on the top of the tube while the blood hemocytes being precipitated in the bottom of the tube , 2ml of I-PRF was collected then injected directly into the joint after arthrocentesis with ringers solution through the first needle .the mandible was manipulated in opening , closing and lateral movements to free the adhesion of the disc.
III-Post operative stage :
the patients in both groups were instructed to have soft diet, heat fomentation over the TMJ area and keep moving the mandible.
Analgesics and antibiotics were prescribed to avoid un necessary complications of infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A comparative, randomised controlled prospective study was conducted to evaluate the efficacy of injectable PRF in management of temporomandibular joint internal derangement in terms of maximum mouth opening,joint pain and clicking. These parameters were evaluated at 1month,3 months and 6 months postoperatively both clinically and using MRI.
| Arm | Type | Receives |
|---|---|---|
| Experimental arm ( TMJ arthrocentesis then administration of injectable PRF) | Experimental | Procedure: TMJ arthrocentesis, Biological: Autologous platelet rich fibrin ( injectable PRF)Patients with TMJ internal derangement (disc displacement with \& without reduction) underwent TMJ arthrocentesis then immediate administration of autologous injectable PRF (platelet-rich fibrin) |
| Active comparator arm ( TMJ arthrocentesis then administration of Hyaluronic acid gel) | Active comparator | Procedure: TMJ arthrocentesis, Device: Hyaluronic acid gel (HA)Patients with TMJ internal derangement ( disc displacement with and without reduction) underwent TMJ arthrocentesis then intraarticular injection of Hyaluronic acid gel |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with TMJ disc displacement with or without reduction between 18-55years old
- Patients unresponsive to conservative treatment of TMD
- Patients with limited mouth opening, painful clicking
- Pain elicited with joint function
Key exclusion criteria (1 listed)
- 1) Myofacial pain dysfunction syndrome MPDS 2) Patients underwent previous TMJ arthrocentesis, arthroscopy or surgery 3) Pregnancy 4) Patients with systemic diseases that impair soft or hard tissue healing 5)Patients with total joint replacement 6) uncooperative patients, those who wouldn't stick to the follow up periods. 7) hysteric and needle phobic patients ( GA is preferred over Local anesthesia in this situation).
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 |
|---|---|---|
| TMJ arthrocentesisJoint arthrocentesis was done to wash out any inflammatory exudate that were detected clinically as joint swelling or as white dots in T2 MRI images. The two needle arthrocentesis technique was used under local anesthesia. Two points were marked along the canthotragal line; the first /posterior point was marked 10mm along the line and 2mm below it ( representative of the glenoid fossa) whereas the second/ anterior point was marked 20mm along the line and 10mm below it( representative of the articular eminence). The first needle was inserted first and about 20ml of ringer's solution was injected to distend the joint capsule then the second needle was inserted and about 100ml of ringer's solution was injected. Throughout the whole procedure, the patients were asked to open, close and protrude their jaw and move their jaw laterally to help the fluid diffuse through the joint and release any adhesions. | Procedure or surgery | Active comparator arm ( TMJ arthrocentesis then administration of Hyaluronic acid gel), Experimental arm ( TMJ arthrocentesis then administration of injectable PRF) |
| Autologous platelet rich fibrin ( injectable PRF)Single intraarticular administration of 2ml of injectable PRF immediately after TMJ arthrocentesis. Injectable PRF was prepared immediately before arthrocentesis from centrifuging (TD4 centrifuge, Hunan Lab we scientific instruments, China) of blood taking from the ulnar vein in a plain glass coated tube without anticoagulants at 700 rpm for 3 minutes , after centrifuging it was separated from the blood hemocytes as I-PRF was collected on the top of the tube while the blood hemocytes was precipitated in the bottom of the tube , 2ml of I-PRF was collected then injected directly into the joint after arthrocentesis with ringers solution through the first needle. | Biological | Experimental arm ( TMJ arthrocentesis then administration of injectable PRF) |
| Hyaluronic acid gel (HA)A single intraarticular administration of 2ml of low molecular weight Hyaluronic acid gel ( Hyalgan, hyaluronic acid sodium salt, Fidia pharmaceuticals, Italy) immediately after joint arthrocentesis. | Device | Active comparator arm ( TMJ arthrocentesis then administration of Hyaluronic acid gel) |
Primary outcome
Maximum mouth opening MMO
Time frame: Patients were scheduled for follow up periods at 1 week, 1 month, 3 months and 6 months.
Maximum mouth opening was measured for each patients preoperatively using a ruler in millimeters. patients with limited mouth opening ( normal mouth opening equals Three fingers of the patients inserted as one column between the upper and lower central incisors or 42.6 ± 5.6 mm).
temporomandibular joint pain
Time frame: Patients were scheduled for follow up periods at 1 week, 1 month , 3 months and 6 months postoperatively
Patients reported joint pain were assessed via Visual Analogue Scale VAS , where 0 represents no pain and 10 represents severe pain.
3 secondary outcomes
Temporomandibular joint clicking
Time frame: These patients were scheduled for follow up periods at 1 week, 1 month,3 months and 6 months postoperatively.
Temporomandibular joint disc position
Time frame: Preoperatively and 6 months postoperatively.
Temporomandibular joint effusion
Time frame: Preoperatively and 6 months postoperatively
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 27 Aug 2026.
- Background: PubMed 31577070Toameh MH, Alkhouri I, Karman MA. Management of patients with disk displacement without reduction of the temporomandibular joint by arthrocentesis alone, plus hyaluronic acid or plus platelet-rich plasma. Dent Med Probl. 2019 Jul-Sep;56(3):265-272. doi: 10.17219/dmp/109329.
- Background: PubMed 35568935Manafikhi M, Ataya J, Heshmeh O. Evaluation of the efficacy of platelet rich fibrin (I-PRF) intra-articular injections in the management of internal derangements of temporomandibular joints - a controlled preliminary prospective clinical study. BMC Musculoskelet Disord. 2022 May 14;23(1):454. doi: 10.1186/s12891-022-05421-7.
- Background: PubMed 36896087Jacob SM, Bandyopadhyay TK, Chattopadhyay PK, Parihar VS. Efficacy of Platelet-Rich Plasma Versus Hyaluronic Acid Following Arthrocentesis for Temporomandibular Joint Disc Disorders: A Randomized Controlled Trial. J Maxillofac Oral Surg. 2022 Dec;21(4):1199-1204. doi: 10.1007/s12663-021-01519-y. Epub 2021 Feb 8.
- Background: PubMed 36414172Hegab AF, Hameed HIAA, Hassaneen AM, Hyder A. Synergistic effect of platelet rich plasma with hyaluronic acid injection following arthrocentesis to reduce pain and improve function in TMJ osteoarthritis. J Stomatol Oral Maxillofac Surg. 2023 Feb;124(1S):101340. doi: 10.1016/j.jormas.2022.11.016. Epub 2022 Nov 19.
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- Background: PubMed 36523721Abbadi W, Kara Beit Z, Al-Khanati NM. Arthrocentesis, Injectable Platelet-Rich Plasma and Combination of Both Protocols of Temporomandibular Joint Disorders Management: A Single-Blinded Randomized Clinical Trial. Cureus. 2022 Nov 11;14(11):e31396. doi: 10.7759/cureus.31396. eCollection 2022 Nov.
- Individual participant dataSharing planned: Undecided
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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 A. El sholkamy, Professor of surgery study chair
Department of oral and maxillofacial surgery, faculty of Dentistry Suez canal university ,Ismailia,Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TMJ arthrocentesis, Autologous platelet rich fibrin ( injectable PRF) and Hyaluronic acid gel (HA) in people with Temporomandibular Joint Internal Derangement, run by Suez Canal 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 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum mouth opening MMO (time frame: Patients were scheduled for follow up periods at 1 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?
On the ClinicalTrials.gov record for NCT07789860, which also lists 10 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 2026.