Temporomandibular Joint Disc DisplacementNCT07373730
Evaluation of the Efficacy of Injectable Platelet-Rich Fibrin Mixed With Hyaluronic Acid in Treatment of Temporomandibular Joint Internal Derangement
A study testing Hyalgan 20 mg in 2 ML Prefilled Syringe and I-PRF in people with Temporomandibular Joint Disc Displacement, run by Suez Canal University at 1 site in Egypt.
Trial summary
we inject I-PRF and Hyaluronic Acid inside the human TMJ with internal derangement after arthrocentesis, and follow-up is made to evaluate the effect of this treatment. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Temporomandibular Joint Disc Displacement
- What is being tested?
- Hyalgan 20 mg in 2 ML Prefilled Syringe and I-PRF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Aug 2023to 31 Jul 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients aged from 18 to 40 years old.
- patients diagnosed with internal derangement of TMJ, suffering from limited mandibular movements, joint pain and clicking.
- Patients who are free from any systemic disease (ASA I).
Who cannot join
- Patients who have myofascial pain dysfunction syndrome only.
- Patients who have previous surgery in TMJ.
- Patients who have previous arthrocentesis within 1 year.
- Patients with prosthetic joint replacement.
- Patients allergic to any components of the injecting solution.
- Patients who received previous trauma to the joint.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Evaluation of the Efficacy of Injectable Platelet Rich Fibrin Mixed With Hyaluronic Acid in Treatment of Temporomandibular Joint Internal Derangement: A Randomized Controlled Trial
we inject I-PRF and Hyaluronic Acid inside the human TMJ with internal derangement after arthrocentesis, and follow-up is made to evaluate the effect of this treatment.
Read the detailed description
This study was made to evaluate the efficacy of injectable Platelet Rich Fibrin (I-PRF) with Hyaluronic Acid (HA) injection after arthrocentesis in treatment of Temporomandibular joint Internal Derangement.
The study was conducted on 30 patients whose ages ranged from 18 to 40 years, presented with impaired jaw function, limited mouth opening, Pain during joint movement and clicking. TMJ internal derangement was verified by preoperative MRI.
Patients with MPDS only, systemic debilitating disease, previous surgery in the TMJ, previous arthrocentesis, previous trauma to the joint were excluded from the study.
Control group: 15 cases were treated by arthrocentesis then injection of 1ml of Hyaluronic acid (HA).
Study group: 15 cases were treated by arthrocentesis then injection of 0.5ml of Hyaluronic acid (HA) and 0.5ml of injectable platelet rich fibrin (I-PRF).
Clinical assessment of pain by VAS, clicking as present or not, maximum mouth opening in millimeters, right and left lateral movements and protrusive movements was done preoperatively and postoperatively at 1,3,6 months.
MRI assessment was done preoperatively and 6 months postoperatively.
- Being tested
- Hyalgan 20 mg in 2 ML Prefilled Syringe, I-PRF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyalgan 20 mg in 2 ML Prefilled SyringeDrug
For the control group: 1mm of the drug was injected into the joint. For the study group: 0.5mm of the drug was injected into the joint.
I-PRFOther
Only given for the study group: 0.5mm of I-PRF was injected into the joint.
| Study group | Role | What they receive |
|---|---|---|
| study group | Active comparator | Not described Receives: Drug: Hyalgan 20 mg in 2 ML Prefilled Syringe; Other: I-PRF |
| control group | Active comparator | Not described Receives: Drug: Hyalgan 20 mg in 2 ML Prefilled Syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum mouth opening
was measured in millimeters using a ruler or digital caliper. It is the vertical distance between the incisal edges of upper and lower central incisors at maximum opening while the patients were instructed to set in an upright position in a dental chair.
Measured: immediate preoperative then 1, 3 and 6 months postoperatively
Lateral to Right movement
was measured in millimeters using a ruler or digital caliper. It is the horizontal distance between the maxillary and the mandibular midlines with the teeth slightly separated and the mandible moved towards the right side.
Measured: immediate preoperative then 1, 3 and 6 months postoperatively
Lateral to Left movement
was measured in millimeters using a ruler or digital caliper. It is the horizontal distance between the maxillary and the mandibular midline with the teeth slightly separated and the mandible moved towards the left side.
Measured: immediate preoperative then 1, 3 and 6 months postoperatively
Protrusive movement
was measured in millimeters using a ruler or digital caliper. It is the distance from midpoint of incisal edge of maxillary incisors to midpoint of incisal edge of the mandibular incisors during mandibular protrusion.
Measured: immediate preoperative then 1, 3 and 6 months postoperatively
Joint Clicking
was measured in terms as present or absent by hearing and palpation over each joint during opening and closing jaw movements.
Measured: immediate preoperative then 1, 3 and 6 months postoperatively
Joint Pain
was measured in a score from 0 to 10 using the visual analogue scale [VAS] over the TMJ area. [ 0 is given when there is no pain, 1-3 mild pain, 4-6 moderate pain, 7-9 severe pain, 10 the worst pain].
Measured: immediate preoperative then 1, 3 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 posted28 Jan 2026
- Study start10 Aug 2023
- Primary completion20 Jun 2024
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint Disc DisplacementStudies 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
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07373730
- Sponsor's protocol ID
- 2023/667
- Status last verified
- Oct 2025
- First submitted
- 2 Dec 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 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 Platelet Rich Fibrin Mixed With Hyaluronic Acid in Treatment of Temporomandibular Joint Internal Derangement: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07373730
- Acronym / sponsor ID
- 2023/667
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 28 Jan 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.
we inject I-PRF and Hyaluronic Acid inside the human TMJ with internal derangement after arthrocentesis, and follow-up is made to evaluate the effect of this treatment.
Detailed description
This study was made to evaluate the efficacy of injectable Platelet Rich Fibrin (I-PRF) with Hyaluronic Acid (HA) injection after arthrocentesis in treatment of Temporomandibular joint Internal Derangement.
The study was conducted on 30 patients whose ages ranged from 18 to 40 years, presented with impaired jaw function, limited mouth opening, Pain during joint movement and clicking. TMJ internal derangement was verified by preoperative MRI.
Patients with MPDS only, systemic debilitating disease, previous surgery in the TMJ, previous arthrocentesis, previous trauma to the joint were excluded from the study.
Control group: 15 cases were treated by arthrocentesis then injection of 1ml of Hyaluronic acid (HA).
Study group: 15 cases were treated by arthrocentesis then injection of 0.5ml of Hyaluronic acid (HA) and 0.5ml of injectable platelet rich fibrin (I-PRF).
Clinical assessment of pain by VAS, clicking as present or not, maximum mouth opening in millimeters, right and left lateral movements and protrusive movements was done preoperatively and postoperatively at 1,3,6 months.
MRI assessment was done preoperatively and 6 months postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Active comparator | Drug: Hyalgan 20 mg in 2 ML Prefilled Syringe, Other: I-PRF |
| control group | Active comparator | Drug: Hyalgan 20 mg in 2 ML Prefilled Syringe |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- patients aged from 18 to 40 years old.
- patients diagnosed with internal derangement of TMJ, suffering from limited mandibular movements, joint pain and clicking.
- Patients who are free from any systemic disease (ASA I).
Key exclusion criteria (6 listed)
- Patients who have myofascial pain dysfunction syndrome only.
- Patients who have previous surgery in TMJ.
- Patients who have previous arthrocentesis within 1 year.
- Patients with prosthetic joint replacement.
- Patients allergic to any components of the injecting solution.
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 |
|---|---|---|
| Hyalgan 20 mg in 2 ML Prefilled SyringeFor the control group: 1mm of the drug was injected into the joint. For the study group: 0.5mm of the drug was injected into the joint. | Drug | control group, study group |
| I-PRFOnly given for the study group: 0.5mm of I-PRF was injected into the joint. | Other | study group |
Primary outcome
Maximum mouth opening
Time frame: immediate preoperative then 1, 3 and 6 months postoperatively
was measured in millimeters using a ruler or digital caliper. It is the vertical distance between the incisal edges of upper and lower central incisors at maximum opening while the patients were instructed to set in an upright position in a dental chair.
Lateral to Right movement
Time frame: immediate preoperative then 1, 3 and 6 months postoperatively
was measured in millimeters using a ruler or digital caliper. It is the horizontal distance between the maxillary and the mandibular midlines with the teeth slightly separated and the mandible moved towards the right side.
Lateral to Left movement
Time frame: immediate preoperative then 1, 3 and 6 months postoperatively
was measured in millimeters using a ruler or digital caliper. It is the horizontal distance between the maxillary and the mandibular midline with the teeth slightly separated and the mandible moved towards the left side.
Protrusive movement
Time frame: immediate preoperative then 1, 3 and 6 months postoperatively
was measured in millimeters using a ruler or digital caliper. It is the distance from midpoint of incisal edge of maxillary incisors to midpoint of incisal edge of the mandibular incisors during mandibular protrusion.
Joint Clicking
Time frame: immediate preoperative then 1, 3 and 6 months postoperatively
was measured in terms as present or absent by hearing and palpation over each joint during opening and closing jaw movements.
Joint Pain
Time frame: immediate preoperative then 1, 3 and 6 months postoperatively
was measured in a score from 0 to 10 using the visual analogue scale [VAS] over the TMJ area. [ 0 is given when there is no pain, 1-3 mild pain, 4-6 moderate pain, 7-9 severe pain, 10 the worst pain].
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 28 Jan 2026.
Related trials for Temporomandibular Joint Disc Displacement
Not yet recruiting
Comparing Dextrose Prolotherapy vs. Sodium Hyaluronic Acid Injections for Jaw Joint Internal Derangement
Temporomandibular Joint Internal Derangement, TMJ-ID
Recruiting
Calcium Gluconate Activated in Anterior Disc Displacement With Reduction of the Temporomandibular Joint
Temporomandibular Joint Disorders
Not yet recruiting
Effects of Orofacial Myofunctional Therapy and Cervical Stabilization Exercises in Patients With Axis-i Group Iia Temporomandibular Dysfunction
Temporo-mandibular Dysfunction, Disc Displacement
Not yet recruiting
Effects of Orofascial Myofunctional Therapy and Cervical Stabilization Exercises on Temporomandibular Dysfunction
Temporomandibular Disorders (TMDs), Temporo-mandibular Dysfunction
Active, not recruitingPhase 2
Assessment of Injectable PRF Versus Dextrose Injection in Temporomandibular Joint in Anterior Disc Displacement With Reduction
TMD
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 Hyalgan 20 mg in 2 ML Prefilled Syringe and I-PRF in people with Temporomandibular Joint Disc Displacement, 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 3 inclusion and 6 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 28 Jan 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: immediate preoperative then 1, 3 and 6 months postoperatively). The study lists 6 primary outcomes in all. 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 28 Jan 2026.