Temporomandibular Joint Internal DerangementNCT07385742
Arthrocentesis-PRF Versus Botulinum Toxin for Management of ADDwR
A study testing Injectable Platelet-Rich Fibrin (I-PRF) Injection and Botulinum Toxin Type A (BOTOX) Injection in people with Temporomandibular Joint Internal Derangement and Temporomandibular Joint Disorders, run by Suez Canal University at 1 site in Egypt.
Trial summary
Temporomandibular joint (TMJ) internal derangement is a common cause of temporomandibular disorders and is often associated with pain, restricted mandibular movement, joint sounds, and functional limitations during mastication and mouth opening. Read more about this study
- Who is it for?
- Ages 15 to 50 years
- Conditions the study is for
- Temporomandibular Joint Internal Derangement, Temporomandibular Joint Disorders, Temporomandibular Disorders (TMD)
- What is being tested?
- Injectable Platelet-Rich Fibrin (I-PRF) Injection and Botulinum Toxin Type A (BOTOX) Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2024to 19 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients aged 15 to 50 years.
- Adults of both genders.
- Patients free from systemic disease (ASA I).
- Patients presenting with persistent symptoms and signs of temporomandibular disorders, specifically anterior disc displacement with reduction (ADDwR).
- Patients willing to comply with the follow-up schedule and treatment protocol.
Who cannot join
- Pregnant or lactating women, or women with osteoporosis.
- Patients who have had previous TMJ surgery.
- Patients who have undergone previous arthrocentesis.
- Any other temporomandibular joint disease that may confound diagnosis (e.g., myofascial pain-dysfunction syndrome, MPDS).
- Patients allergic to components of the injection solutions.
- Patients with previous trauma to the TMJ.
- Patients with metal bullets in the body, metallic foreign body in the eye, or intracranial aneurysm clips (unless made of titanium).
- Patients using anticoagulant or immunosuppressive medications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study Between Arthrocentesis Combined With Intra-Articular Injectable Platelet-Rich Fibrin Versus Ultrasound-Guided Lateral Pterygoid Botulinum Toxin Injection For Management of Anterior Disc Displacement With Reduction
Temporomandibular joint (TMJ) internal derangement is a common cause of temporomandibular disorders and is often associated with pain, restricted mandibular movement, joint sounds, and functional limitations during mastication and mouth opening. Various treatment modalities have been proposed to manage these symptoms, aiming to reduce pain and improve joint function.
This randomized clinical study was conducted to compare the effectiveness of botulinum toxin type A (BOTOX) injection into the lateral pterygoid muscle versus intracapsular injection of injectable platelet-rich fibrin (I-PRF) in the management of TMJ internal derangement. A total of 20 patients diagnosed with TMJ internal derangement were randomly allocated into two equal groups. Group I received intracapsular I-PRF injections into the superior joint space of the temporomandibular joint, while group II received botulinum toxin injections into the lateral pterygoid muscle.
Read more
Clinical evaluation was performed using subjective and objective parameters at one, three, and six months following treatment. Outcomes included assessment of pain, maximum mouth opening, mandibular movements, joint tenderness, and muscle tenderness upon palpation. Radiographic evaluation was conducted using magnetic resonance imaging (MRI) to assess intra-articular changes of the temporomandibular joint following the interventions.
The study aimed to determine which treatment modality provided superior clinical and radiographic outcomes for the management of TMJ internal derangement.
Read the detailed description
Temporomandibular joint (TMJ) internal derangement represents a common cause of temporomandibular disorders (TMDs) and is frequently associated with pain and functional limitations. Patients affected by TMJ internal derangement commonly present with pain during mastication, difficulty or pain during mouth opening, joint sounds such as clicking or crepitation, and preauricular pain. Due to the multifactorial nature of this condition, numerous treatment modalities have been investigated to achieve effective symptom relief and functional improvement.
The aim of this clinical study was to evaluate and compare the effectiveness of botulinum toxin type A (BOTOX) injection into the lateral pterygoid muscle versus intracapsular injection of injectable platelet-rich fibrin (I-PRF) for the management of TMJ internal derangement.
This randomized clinical study was conducted on a total of 20 patients diagnosed with TMJ internal derangement. The participants were randomly and equally allocated into two groups using an online randomization tool (www.randomizer.org). Group I consisted of 10 patients who received intracapsular injections of injectable platelet-rich fibrin (I-PRF) into the superior joint space of the temporomandibular joint. Group II consisted of 10 patients who received botulinum toxin type A injections into the lateral pterygoid muscle.
Patients in both groups were evaluated using both subjective and objective parameters at baseline and during follow-up periods at one month, three months, and six months following injection. Clinical evaluation included assessment of pain, maximum mouth opening, and mandibular movements in all directions to determine improvement in mouth mobility. Tenderness was assessed by palpation of the masticatory muscles, including the temporalis, masseter, and lateral pterygoid muscles, as well as palpation of the temporomandibular joint through the external auditory canal.
Radiographic evaluation was performed using magnetic resonance imaging (MRI) to assess intra-articular changes of the temporomandibular joint following treatment. MRI findings were used to evaluate joint structure, disc position, and overall intra-articular condition after the intervention.
The outcomes of this study were analyzed to determine which treatment modality provided superior clinical and radiographic improvement in patients with TMJ internal derangement.
- Conditions
- Temporomandibular Joint Internal Derangement, Temporomandibular Joint Disorders, Temporomandibular Disorders (TMD), TMJ Pain
- Being tested
- Injectable Platelet-Rich Fibrin (I-PRF) Injection, Botulinum Toxin Type A (BOTOX) Injection
- Keywords
- Temporomandibular Joint, TMJ Internal Derangement, Botulinum Toxin Type A, BOTOX Injection, Platelet Rich Fibrin, Injectable PRF, Lateral Pterygoid Muscle
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injectable Platelet-Rich Fibrin (I-PRF) InjectionProcedure or surgery
Also called I-PRF, Autologous Platelet-Rich Fibrin
Participants in this arm underwent arthrocentesis of the temporomandibular joint, followed by injection of 1 mL of intra-articular injectable platelet-rich fibrin (I-PRF) into the superior joint space.
Botulinum Toxin Type A (BOTOX) InjectionDrug
Also called BTX-A, Botulinum Neurotoxin Type A
Participants in this arm received an ultrasound-guided injection of 7 mL containing 35 units of botulinum toxin type A (BOTOX) into the lateral pterygoid muscle.
| Study group | Role | What they receive |
|---|---|---|
| I-PRF Injection Group (Group I) | Experimental | This arm included 10 patients who underwent arthrocentesis of the temporomandibular joint, followed by 1 mL of intra-articular injectable platelet-rich fibrin (I-PRF). Receives: Procedure: Injectable Platelet-Rich Fibrin (I-PRF) Injection |
| Botulinum Toxin Injection Group (Group II) | Experimental | This arm included 10 patients who received an ultrasound-guided injection of 7 mL containing 35 units of botulinum toxin type A (BOTOX) into the lateral pterygoid muscle. Receives: Drug: Botulinum Toxin Type A (BOTOX) Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score (Visual Analogue Scale, VAS)
Pain associated with temporomandibular joint internal derangement was assessed using a 10-point visual analogue scale (VAS), where 0 indicates no pain and 10 indicates the worst pain. Pain was measured at baseline (pre-injection) and at follow-up visits. Comparisons were made within each group over time and between the I-PRF and BOTOX groups to determine the relative effectiveness of each treatment in reducing TMJ pain.
Measured: 1 month, 3 months, and 6 months post-injection
Joint Sounds (Clicking) Assessment
The presence or absence of TMJ clicking was assessed by bimanual palpation during mouth opening and closing. Changes over time were recorded within groups and between the I-PRF and BOTOX groups.
Measured: 1 month, 3 months, and 6 months post-injection
MRI Assessment of Disc Position
MRI was performed to evaluate the position and structure of the TMJ articular disc. Disc positions were categorized as Superior (Normal), Reducing Disc Displacement (RDD), or Non-Reducing Disc Displacement (NRDD). Changes were compared within each group over time and between groups.
Measured: Baseline (Preoperative) and 6 months post-injection
Secondary outcomes (3)
Maximal Mouth Opening (MMO)
MMO was measured from the incisal edge of the upper central incisors to the incisal edge of the lower central incisors using a digital caliper. Measurements were taken at baseline and follow-up visits. Changes were compared within and between the I-PRF and BOTOX groups to evaluate improvement in mouth opening.
Measured: 1 month, 3 months, and 6 months post-injection
Lateral Mandibular Movements (Right and Left)
Right and left lateral mandibular movements were measured from the maxillary midline using a millimeter ruler or caliper. Changes in lateral movement were evaluated within each group over time and between groups.
Measured: 1 month, 3 months, and 6 months post-injection
Protrusive Mandibular Movement (PM)
Protrusive mandibular movement was measured from the midpoint of the maxillary central incisors to the midpoint of the mandibular central incisors using a millimeter ruler or caliper. Progression was assessed within each group and between the I-PRF and BOTOX groups.
Measured: 1 month, 3 months, and 6 months post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start10 Jan 2024
- Primary completion11 Mar 2025
- Study completion19 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study used a parallel assignment design in which 20 patients with temporomandibular joint internal derangement were randomly assigned into two equal groups. Group I received intracapsular injectable platelet-rich fibrin (I-PRF) into the superior joint space of the temporomandibular joint (Arthrocentesis-PRF), while group II received botulinum toxin type A injections into the lateral pterygoid muscle. Each participant received only one of the two interventions and was followed for clinical and radiographic outcomes at one, three, and six months. The interventions were administered concurrently across groups, and the effects of each treatment were compared between the groups.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ammar Yasser Mohamed Metwally, Suez Canal University
- Investigators
- Mohamed Said Hamed, Professor, Study chair, Professor of Oral and Maxillofacial Surgery, Faculty of Dentistry - Suez Canal UniversityAhmed Abd elmohsen Younis, Assistant. Professor, Study director, Assistant. Professor of Oral and Maxillofacial Surgery, Faculty of Dentistry - Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07385742
- Sponsor's protocol ID
- 715/2023
- Status last verified
- Oct 2026
- First submitted
- 25 Jan 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yoshida K. Botulinum Neurotoxin Injection for the Treatment of Recurrent Temporomandibular Joint Dislocation with and without Neurogenic Muscular Hyperactivity. Toxins (Basel). 2018 Apr 25;10(5):174. doi: 10.3390/toxins10050174.
PubMed 29693593Rezazadeh F, Esnaashari N, Azad A, Emad S. The effects of botulinum toxin A injection on the lateral pterygoid muscle in patients with a painful temporomandibular joint click: a randomized clinical trial study. BMC Oral Health. 2022 May 31;22(1):217. doi: 10.1186/s12903-022-02220-3.
PubMed 35641993Manafikhi 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 35568935Chung PY, Lin MT, Chang HP. Effectiveness of platelet-rich plasma injection in patients with temporomandibular joint osteoarthritis: a systematic review and meta-analysis of randomized controlled trials. Oral Surg Oral Med Oral Pathol Oral Radiol. 2019 Feb;127(2):106-116. doi: 10.1016/j.oooo.2018.09.003. Epub 2018 Sep 26.
PubMed 30449691Bousnaki 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 29066000Bakke M, Moller E, Werdelin LM, Dalager T, Kitai N, Kreiborg S. Treatment of severe temporomandibular joint clicking with botulinum toxin in the lateral pterygoid muscle in two cases of anterior disc displacement. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2005 Dec;100(6):693-700. doi: 10.1016/j.tripleo.2004.11.019.
PubMed 16301150Albilia J DMD, MSc, Herrera-Vizcaino C DDS, Weisleder H BSc, Choukroun J MD, Ghanaati S MD, DMD, PhD. Liquid platelet-rich fibrin injections as a treatment adjunct for painful temporomandibular joints: preliminary results. Cranio. 2020 Sep;38(5):292-304. doi: 10.1080/08869634.2018.1516183. Epub 2018 Sep 20.
PubMed 30231809
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Arthrocentesis Combined With Intra-Articular Injectable Platelet-Rich Fibrin Versus Ultrasound-Guided Lateral Pterygoid Botulinum Toxin Injection For Management of Anterior Disc Displacement With Reduction
- ClinicalTrials.gov ID
- NCT07385742
- Acronym / sponsor ID
- 715/2023
- Conditions
- Temporomandibular Joint Internal Derangement, Temporomandibular Joint Disorders, Temporomandibular Disorders (TMD), TMJ Pain
- Keywords
- Temporomandibular Joint, TMJ Internal Derangement, Botulinum Toxin Type A, BOTOX Injection, Platelet Rich Fibrin, Injectable PRF, Lateral Pterygoid Muscle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 11 Mar 2025 (actual)
- Study completion
- 19 Apr 2025 (actual)
- First posted
- 4 Feb 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.
Temporomandibular joint (TMJ) internal derangement is a common cause of temporomandibular disorders and is often associated with pain, restricted mandibular movement, joint sounds, and functional limitations during mastication and mouth opening. Various treatment modalities have been proposed to manage these symptoms, aiming to reduce pain and improve joint function.
This randomized clinical study was conducted to compare the effectiveness of botulinum toxin type A (BOTOX) injection into the lateral pterygoid muscle versus intracapsular injection of injectable platelet-rich fibrin (I-PRF) in the management of TMJ internal derangement. A total of 20 patients diagnosed with TMJ internal derangement were randomly allocated into two equal groups. Group I received intracapsular I-PRF injections into the superior joint space of the temporomandibular joint, while group II received botulinum toxin injections into the lateral pterygoid muscle.
Clinical evaluation was performed using subjective and objective parameters at one, three, and six months following treatment. Outcomes included assessment of pain, maximum mouth opening, mandibular movements, joint tenderness, and muscle tenderness upon palpation. Radiographic evaluation was conducted using magnetic resonance imaging (MRI) to assess intra-articular changes of the temporomandibular joint following the interventions.
The study aimed to determine which treatment modality provided superior clinical and radiographic outcomes for the management of TMJ internal derangement.
Detailed description
Temporomandibular joint (TMJ) internal derangement represents a common cause of temporomandibular disorders (TMDs) and is frequently associated with pain and functional limitations. Patients affected by TMJ internal derangement commonly present with pain during mastication, difficulty or pain during mouth opening, joint sounds such as clicking or crepitation, and preauricular pain. Due to the multifactorial nature of this condition, numerous treatment modalities have been investigated to achieve effective symptom relief and functional improvement.
The aim of this clinical study was to evaluate and compare the effectiveness of botulinum toxin type A (BOTOX) injection into the lateral pterygoid muscle versus intracapsular injection of injectable platelet-rich fibrin (I-PRF) for the management of TMJ internal derangement.
This randomized clinical study was conducted on a total of 20 patients diagnosed with TMJ internal derangement. The participants were randomly and equally allocated into two groups using an online randomization tool (www.randomizer.org). Group I consisted of 10 patients who received intracapsular injections of injectable platelet-rich fibrin (I-PRF) into the superior joint space of the temporomandibular joint. Group II consisted of 10 patients who received botulinum toxin type A injections into the lateral pterygoid muscle.
Patients in both groups were evaluated using both subjective and objective parameters at baseline and during follow-up periods at one month, three months, and six months following injection. Clinical evaluation included assessment of pain, maximum mouth opening, and mandibular movements in all directions to determine improvement in mouth mobility. Tenderness was assessed by palpation of the masticatory muscles, including the temporalis, masseter, and lateral pterygoid muscles, as well as palpation of the temporomandibular joint through the external auditory canal.
Radiographic evaluation was performed using magnetic resonance imaging (MRI) to assess intra-articular changes of the temporomandibular joint following treatment. MRI findings were used to evaluate joint structure, disc position, and overall intra-articular condition after the intervention.
The outcomes of this study were analyzed to determine which treatment modality provided superior clinical and radiographic improvement in patients with TMJ internal derangement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study used a parallel assignment design in which 20 patients with temporomandibular joint internal derangement were randomly assigned into two equal groups. Group I received intracapsular injectable platelet-rich fibrin (I-PRF) into the superior joint space of the temporomandibular joint (Arthrocentesis-PRF), while group II received botulinum toxin type A injections into the lateral pterygoid muscle. Each participant received only one of the two interventions and was followed for clinical and radiographic outcomes at one, three, and six months. The interventions were administered concurrently across groups, and the effects of each treatment were compared between the groups.
| Arm | Type | Receives |
|---|---|---|
| I-PRF Injection Group (Group I) | Experimental | Procedure: Injectable Platelet-Rich Fibrin (I-PRF) InjectionThis arm included 10 patients who underwent arthrocentesis of the temporomandibular joint, followed by 1 mL of intra-articular injectable platelet-rich fibrin (I-PRF). |
| Botulinum Toxin Injection Group (Group II) | Experimental | Drug: Botulinum Toxin Type A (BOTOX) InjectionThis arm included 10 patients who received an ultrasound-guided injection of 7 mL containing 35 units of botulinum toxin type A (BOTOX) into the lateral pterygoid muscle. |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients aged 15 to 50 years.
- Adults of both genders.
- Patients free from systemic disease (ASA I).
- Patients presenting with persistent symptoms and signs of temporomandibular disorders, specifically anterior disc displacement with reduction (ADDwR).
- Patients willing to comply with the follow-up schedule and treatment protocol.
Key exclusion criteria (8 listed)
- Pregnant or lactating women, or women with osteoporosis.
- Patients who have had previous TMJ surgery.
- Patients who have undergone previous arthrocentesis.
- Any other temporomandibular joint disease that may confound diagnosis (e.g., myofascial pain-dysfunction syndrome, MPDS).
- Patients allergic to components of the injection solutions.
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 |
|---|---|---|
| Injectable Platelet-Rich Fibrin (I-PRF) InjectionAlso: I-PRF, Autologous Platelet-Rich FibrinParticipants in this arm underwent arthrocentesis of the temporomandibular joint, followed by injection of 1 mL of intra-articular injectable platelet-rich fibrin (I-PRF) into the superior joint space. | Procedure or surgery | I-PRF Injection Group (Group I) |
| Botulinum Toxin Type A (BOTOX) InjectionAlso: BTX-A, Botulinum Neurotoxin Type AParticipants in this arm received an ultrasound-guided injection of 7 mL containing 35 units of botulinum toxin type A (BOTOX) into the lateral pterygoid muscle. | Drug | Botulinum Toxin Injection Group (Group II) |
Primary outcome
Pain Score (Visual Analogue Scale, VAS)
Time frame: 1 month, 3 months, and 6 months post-injection
Pain associated with temporomandibular joint internal derangement was assessed using a 10-point visual analogue scale (VAS), where 0 indicates no pain and 10 indicates the worst pain. Pain was measured at baseline (pre-injection) and at follow-up visits. Comparisons were made within each group over time and between the I-PRF and BOTOX groups to determine the relative effectiveness of each treatment in reducing TMJ pain.
Joint Sounds (Clicking) Assessment
Time frame: 1 month, 3 months, and 6 months post-injection
The presence or absence of TMJ clicking was assessed by bimanual palpation during mouth opening and closing. Changes over time were recorded within groups and between the I-PRF and BOTOX groups.
MRI Assessment of Disc Position
Time frame: Baseline (Preoperative) and 6 months post-injection
MRI was performed to evaluate the position and structure of the TMJ articular disc. Disc positions were categorized as Superior (Normal), Reducing Disc Displacement (RDD), or Non-Reducing Disc Displacement (NRDD). Changes were compared within each group over time and between groups.
3 secondary outcomes
Maximal Mouth Opening (MMO)
Time frame: 1 month, 3 months, and 6 months post-injection
Lateral Mandibular Movements (Right and Left)
Time frame: 1 month, 3 months, and 6 months post-injection
Protrusive Mandibular Movement (PM)
Time frame: 1 month, 3 months, and 6 months post-injection
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 7 Oct 2026.
- Background: PubMed 29693593Yoshida K. Botulinum Neurotoxin Injection for the Treatment of Recurrent Temporomandibular Joint Dislocation with and without Neurogenic Muscular Hyperactivity. Toxins (Basel). 2018 Apr 25;10(5):174. doi: 10.3390/toxins10050174.
- Background: PubMed 35641993Rezazadeh F, Esnaashari N, Azad A, Emad S. The effects of botulinum toxin A injection on the lateral pterygoid muscle in patients with a painful temporomandibular joint click: a randomized clinical trial study. BMC Oral Health. 2022 May 31;22(1):217. doi: 10.1186/s12903-022-02220-3.
- 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 30449691Chung PY, Lin MT, Chang HP. Effectiveness of platelet-rich plasma injection in patients with temporomandibular joint osteoarthritis: a systematic review and meta-analysis of randomized controlled trials. Oral Surg Oral Med Oral Pathol Oral Radiol. 2019 Feb;127(2):106-116. doi: 10.1016/j.oooo.2018.09.003. Epub 2018 Sep 26.
- Background: PubMed 29066000Bousnaki 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.
- Background: PubMed 16301150Bakke M, Moller E, Werdelin LM, Dalager T, Kitai N, Kreiborg S. Treatment of severe temporomandibular joint clicking with botulinum toxin in the lateral pterygoid muscle in two cases of anterior disc displacement. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2005 Dec;100(6):693-700. doi: 10.1016/j.tripleo.2004.11.019.
- Background: PubMed 30231809Albilia J DMD, MSc, Herrera-Vizcaino C DDS, Weisleder H BSc, Choukroun J MD, Ghanaati S MD, DMD, PhD. Liquid platelet-rich fibrin injections as a treatment adjunct for painful temporomandibular joints: preliminary results. Cranio. 2020 Sep;38(5):292-304. doi: 10.1080/08869634.2018.1516183. Epub 2018 Sep 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Said Hamed, Professor study chair
Professor of Oral and Maxillofacial Surgery, Faculty of Dentistry - Suez Canal University
Ahmed Abd elmohsen Younis, Assistant. Professor study director
Assistant. Professor of Oral and Maxillofacial Surgery, Faculty of Dentistry - Suez Canal 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 Injectable Platelet-Rich Fibrin (I-PRF) Injection and Botulinum Toxin Type A (BOTOX) Injection in people with Temporomandibular Joint Internal Derangement and Temporomandibular Joint Disorders, 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 5 inclusion and 8 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 7 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score (Visual Analogue Scale, VAS) (time frame: 1 month, 3 months, and 6 months post-injection). 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 NCT07385742, which also lists 7 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 7 Oct 2026.