TMJ Disc DisorderNCT06207955
I-PRF After Arthrocentesis Plus Botox Injection to Lateral Pterygoid Muscle in Treatment of Anterior Disc Displacement
A study testing TMJ Arthrocentesis Followed By Injectable Platelet Rich Fibrin And Botulinum Toxin Type A, TMJ Arthrocentesis Followed By Injectable Platelet Rich Fibrin and TMJ Arthrocentesis in people with TMJ Disc Disorder and TMJ Pain, run by Fayoum University at 1 site in Egypt.
Trial summary
Aim of Study : To evaluate the efficacy of TMJ arhtrocentesis followed by injection of liquid platelet rich fibrin (I-PRF ) in addition to intramuscular injection of lateral pterygoid muscle with botulinum toxin on clinical outcomes of painful TMJ , maximum mouth opening , joint sounds and range of lateral movement in… Read more about this study
- Who is it for?
- Ages 16 to 45 years
- Conditions the study is for
- TMJ Disc Disorder, TMJ Pain
- What is being tested?
- TMJ Arthrocentesis Followed By Injectable Platelet Rich Fibrin And Botulinum Toxin Type A, TMJ Arthrocentesis Followed By Injectable Platelet Rich Fibrin and TMJ Arthrocentesis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Jan 2024to 11 Sep 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 16 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with painful tmj during jaw movements
- Patients with joint sounds ( clicking ) during jaw opening and mastication
- Patients age range from 16 years old to 45 years old
- Patients with Class I maxillo-mandibular relationship
- Patients with reduced mouth opening
- All patients diagnosed clinically and radiographically by MRI as TMJ anterior disc displacement with reduction
Who cannot join
- Patient with history of recent trauma
- Patients with malocclusion
- Patients with systematic condition that affect bone and joints such as osteoarthritis , systemic lupus and epilepsy .
- Patients allergic to botox injection
- Pregnant or lactating females
- Patients with non-reducible disc on MRI
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- Patients contraindicated to exposure to MRI
- Patients with previous tmj arthrocentesis , arthroscopy or TMJ surgery
- Significant mechanical obstruction that prevents mouth opening, acute capsulitis, benign or malignant temporomandibular joint lesions.
- Patients with blood diseases, and coagulation disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Intra-articular Injection of Platelet-Rich Fibrin After Arthrocentesis Followed by Lateral Pterygoid Muscle Injection With Botulinum Toxin Type A Improve Clinical Outcomes for Anterior Disc Displacement?
Aim of Study : To evaluate the efficacy of TMJ arhtrocentesis followed by injection of liquid platelet rich fibrin (I-PRF ) in addition to intramuscular injection of lateral pterygoid muscle with botulinum toxin on clinical outcomes of painful TMJ , maximum mouth opening , joint sounds and range of lateral movement in patients with TMJ anterior disc displacement with reduction
Hypothesis : Intramuscular injection of lateral pterygoid muscle with botulinum toxin plus TMJ intra-articular injection of liquid platelet rich fibrin after arthrocentesis are more effective than TMJ arthrocentesis followed by intra-articular injection of ( I-PRF ) or TMJ arthrocentesis only .
- Conditions
- TMJ Disc Disorder, TMJ Pain
- Being tested
- TMJ Arthrocentesis Followed By Injectable Platelet Rich Fibrin And Botulinum Toxin Type A, TMJ Arthrocentesis Followed By Injectable Platelet Rich Fibrin, TMJ Arthrocentesis
- Keywords
- Anterior Disc Displacement, TMJ Clicking, I-PRF, Lateral Pterygoid Muscle, Arthrocentesis, Botulinum Toxin Type A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMJ Arthrocentesis Followed By Injectable Platelet Rich Fibrin And Botulinum Toxin Type ADrug
TMJ Arthrocentesis I-PRF Intra-articular Injection Botulinum Toxin Type A to Lateral Pterygoid Muscle
TMJ Arthrocentesis Followed By Injectable Platelet Rich FibrinDrug
TMJ Arthrocentesis I-PRF Intra-articular Injection
TMJ ArthrocentesisDrug
TMJ Arthrocentesis By Saline
| Study group | Role | What they receive |
|---|---|---|
| TMJ arthrocentesis + (I-PRF) injection & injection of Botox to lateral pterygoid muscle | Active comparator | Not described Receives: Drug: TMJ Arthrocentesis Followed By Injectable Platelet Rich Fibrin And Botulinum Toxin Type A |
| TMJ arthrocentesis followed by intra-articular injection of liquid platelet rich fibrin ( I-PRF ) | Active comparator | Not described Receives: Drug: TMJ Arthrocentesis Followed By Injectable Platelet Rich Fibrin |
| TMJ arthrocentesis | Active comparator | Not described Receives: Drug: TMJ Arthrocentesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Mouth Opening
Maximum mouth opening will be measured as the distance from incisal edges of the upper and lower central incisors using a ruler and will be evaluated preoperatively , immediately after the procedure , 1month , 3 months and 6 months postoperative .
Measured: 6 months
Secondary outcomes (2)
Clicking
Joint sounds also will be evaluated during opening and closing of the jaws and during lateral movements preoperatively , immediately after the procedure , 1 months , 3 months and 6 months postoperative
Measured: 6 months
Lateral movement
Range of lateral mandibular movement will be measured using Vernier caliper in millimeters as the horizontal distance extending from maxillary midline to mandibular midline by asking the patient to move the mandible to one side then to the other side to maximum extent
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start18 Jan 2024
- Primary completion2 Apr 2025
- Study completion11 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMJ Disc DisorderStudies of the same condition, open and under way.
- More trials run by Fayoum 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Taha Ahmed Mohamed, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06207955
- Sponsor's protocol ID
- 23122023
- Status last verified
- Aug 2026
- First submitted
- 23 Dec 2023
- Last updated
- 1 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Intra-articular Injection of Platelet-Rich Fibrin After Arthrocentesis Followed by Lateral Pterygoid Muscle Injection With Botulinum Toxin Type A Improve Clinical Outcomes for Anterior Disc Displacement?
- ClinicalTrials.gov ID
- NCT06207955
- Acronym / sponsor ID
- 23122023
- Conditions
- TMJ Disc Disorder, TMJ Pain
- Keywords
- Anterior Disc Displacement, TMJ Clicking, I-PRF, Lateral Pterygoid Muscle, Arthrocentesis, Botulinum Toxin Type A
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 2 Apr 2025 (actual)
- Study completion
- 11 Sep 2025 (actual)
- First posted
- 17 Jan 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.
Aim of Study : To evaluate the efficacy of TMJ arhtrocentesis followed by injection of liquid platelet rich fibrin (I-PRF ) in addition to intramuscular injection of lateral pterygoid muscle with botulinum toxin on clinical outcomes of painful TMJ , maximum mouth opening , joint sounds and range of lateral movement in patients with TMJ anterior disc displacement with reduction
Hypothesis : Intramuscular injection of lateral pterygoid muscle with botulinum toxin plus TMJ intra-articular injection of liquid platelet rich fibrin after arthrocentesis are more effective than TMJ arthrocentesis followed by intra-articular injection of ( I-PRF ) or TMJ arthrocentesis only .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TMJ arthrocentesis + (I-PRF) injection & injection of Botox to lateral pterygoid muscle | Active comparator | Drug: TMJ Arthrocentesis Followed By Injectable Platelet Rich Fibrin And Botulinum Toxin Type A |
| TMJ arthrocentesis followed by intra-articular injection of liquid platelet rich fibrin ( I-PRF ) | Active comparator | Drug: TMJ Arthrocentesis Followed By Injectable Platelet Rich Fibrin |
| TMJ arthrocentesis | Active comparator | Drug: TMJ Arthrocentesis |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Patients with painful tmj during jaw movements
- Patients with joint sounds ( clicking ) during jaw opening and mastication
- Patients age range from 16 years old to 45 years old
- Patients with Class I maxillo-mandibular relationship
- Patients with reduced mouth opening
Key exclusion criteria (10 listed)
- Patient with history of recent trauma
- Patients with malocclusion
- Patients with systematic condition that affect bone and joints such as osteoarthritis , systemic lupus and epilepsy .
- Patients allergic to botox injection
- Pregnant or lactating females
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 Arthrocentesis Followed By Injectable Platelet Rich Fibrin And Botulinum Toxin Type ATMJ Arthrocentesis I-PRF Intra-articular Injection Botulinum Toxin Type A to Lateral Pterygoid Muscle | Drug | TMJ arthrocentesis + (I-PRF) injection & injection of Botox to lateral pterygoid muscle |
| TMJ Arthrocentesis Followed By Injectable Platelet Rich FibrinTMJ Arthrocentesis I-PRF Intra-articular Injection | Drug | TMJ arthrocentesis followed by intra-articular injection of liquid platelet rich fibrin ( I-PRF ) |
| TMJ ArthrocentesisTMJ Arthrocentesis By Saline | Drug | TMJ arthrocentesis |
Primary outcome
Maximum Mouth Opening
Time frame: 6 months
Maximum mouth opening will be measured as the distance from incisal edges of the upper and lower central incisors using a ruler and will be evaluated preoperatively , immediately after the procedure , 1month , 3 months and 6 months postoperative .
2 secondary outcomes
Clicking
Time frame: 6 months
Lateral movement
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TMJ Arthrocentesis Followed By Injectable Platelet Rich Fibrin And Botulinum Toxin Type A, TMJ Arthrocentesis Followed By Injectable Platelet Rich Fibrin and TMJ Arthrocentesis in people with TMJ Disc Disorder and TMJ Pain, run by Fayoum 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 6 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: finished, as of the sponsor's last update on 1 Sep 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?
Maximum Mouth Opening (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.