Temporomandibular Disorders (TMD)LPCGF in TMDsNCT07075276
Liquid Phase Concentrated Growth Factor Versus Conventional Arthrocentesis in Temporomandibular Disc Displacement
A study testing Liquid Phase Concentrated Growth Factor and Conventional arthrocentesis in people with Temporomandibular Disorders (TMD) and Internal Derangement of the Tempromandibular Joint, run by Horus University at 1 site in Egypt.
Trial summary
This study aims to rigorously assess the effectiveness of LPCGF in the management of internal disc displacement in patients with TMD through a randomized clinical trial. By comparing LPCGF therapy with conventional arthrocentesis, this research looks to provide robust evidence on the efficacy, safety, and potential… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Disorders (TMD), Internal Derangement of the Tempromandibular Joint, Anterior Disc Displacement
- What is being tested?
- Liquid Phase Concentrated Growth Factor and Conventional arthrocentesis
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Adults aged 18-45 years. 2. Patients scored as (ASA I).9 3. Presence of complete or nearly complete set of natural dentition with Angle class I occlusion. 4. Diagnosed with unilateral involvement of disc displacement, according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD).10 5. Symptoms include one or more of the following: pain, joint sounds, and limited mandibular movement (Maximum Mouth Opening< 40mm) 6. No prior surgical intervention for TMD. 7. Patient's willingness to participate and follow the study protocol.
Who cannot join
- 1. TMJ pathology related to mechanical deformities 2. Psychiatric problems or presence of systemic diseases that may affect healing (e.g., uncontrolled diabetes, autoimmune disorders, hematologic or neurologic disorders, inflammatory or connective tissue disorders as well as rheumatological or previous infectious diseases, head and neck cancer). 3. Patient unwilling or has contraindication to MRI 4. Previous injections or surgical interventions of the TMJ. 5. Concurrent use of anticoagulants or anti-inflammatory medications within the last 30 days. 6. Pregnant or breastfeeding women. 7. History of trauma or infection in the TMJ region. 8. Allergy to local anesthetics or other components used in the study. 9. Patients diagnosed with (Disc Displacement with reduction with no pain or limited mandibular movements).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry- Horus University in Egypt
Damietta, New Damietta, 34518
Mohamed Ali Habib, Teaching Assistant, +201069505336, mbasiouny@horus.edu.eg
About this study
Official title: Injection of Liquid Phase Concentrated Growth Factor Versus Conventional Arthrocentesis in Management of Temporomandibular Disc Displacement: A Randomized Controlled Clinical Trial
This study aims to rigorously assess the effectiveness of LPCGF in the management of internal disc displacement in patients with TMD through a randomized clinical trial. By comparing LPCGF therapy with conventional arthrocentesis, this research looks to provide robust evidence on the efficacy, safety, and potential role of (LPCGF) as an alternative therapeutic choice for IDD.
- Conditions
- Temporomandibular Disorders (TMD), Internal Derangement of the Tempromandibular Joint, Anterior Disc Displacement
- Being tested
- Liquid Phase Concentrated Growth Factor, Conventional arthrocentesis
- Keywords
- Temporomandibular disorder, Concentrated growth factor, Anterior disc displacement with reduction, Anterior disc displacement without reduction, Arthrocentesis
- 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.
Liquid Phase Concentrated Growth FactorProcedure or surgery
16 patients with anterior disc displacement with or without reduction randomly allocated to be treated with injection of liquid phase concentrated growth factor
Conventional arthrocentesisProcedure or surgery
16 patients with anterior disc displacement with or without reduction randomly allocated to be treated with conventional arthrocentesis
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 16 patients have anterior disc displacement with or without reduction will be treated with injection of liquid phase concentrated growth factor Receives: Procedure: Liquid Phase Concentrated Growth Factor |
| Group B | Active comparator | 16 patients have anterior disc displacement with or without reduction will be treated with conventional arthrocentesis Receives: Procedure: Conventional arthrocentesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess and comparing the pain of both groups
measured using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst pain)
Measured: Assessed at baseline (before treatment),1week, 1 month, 3 months, and 6 months after the intervention.
Assess and comparing the mouth opening of both groups
measured in millimeters (Maximum inter-incisal opening measured by the distance in millimeters between the incisal edges of the upper and lower central incisors in vertical direction at maximum pain free mouth opening) by using caliper. and comparing the results of both groups
Measured: Assessed at baseline (before treatment),1week, 1 month, 3 months, and 6 months after the intervention.
Secondary outcomes (5)
Joint sounds
(clicking and crepitus) evaluated by clinical examination; presence of joint noise at opening and closing was evaluated by light bilateral digital palpation during jaw movement.
Measured: Assessed at baseline (before treatment),1week, 1 month, 3 months, and 6 months after the intervention.
Mandibular deviation during mouth opening.
By clinical examination , observe mandibular deviation toward right or left side or deflection during opening and closing the mouth
Measured: Assessed at baseline (before treatment),1week, 1 month, 3 months, and 6 months after the intervention.
Lateral and protrusive movements
(Range of lateral and protrusive movements measured by the distance in millimeters between the upper and lower midlines in horizontal direction on lateral and protrusive movements by using caliper).
Measured: Assessed at baseline (before treatment),1week, 1 month, 3 months, and 6 months after the intervention
tenderness on palpation
Presence or absence of joint tenderness on palpation: recorded as tender or not tender.
Measured: Assessed at baseline (before treatment),1week, 1 month, 3 months, and 6 months after the intervention.
TMD symptoms
TMD symptoms were evaluated using Modified Helkimo Index
Measured: Assessed at baseline (before treatment),1week, 1 month, 3 months, and 6 months after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start1 Oct 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Disorders (TMD)Studies of the same condition, open and under way.
- 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
- 16 patients with anterior disc displacement with or without reduction will be treated with liquid phase concentrated growth factor and 16 patients will be treated with conventional arthrocentesis
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Horus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ali Habib, Horus University
- Investigators
- Mohamed Ali Habib, Teaching Assistant, Principal investigator, Horus University in Egypt - Faculty of dentistryEman AbdElsalam Yousef, Ass. prof, Study director, Horus University in Egypt- Faculty of dentistryAhmed Khalil, lecturer, Study director, Horus University in Egypt - Faculty of dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07075276
- Sponsor's protocol ID
- CGF for management of TMDs
- Acronym
- LPCGF in TMDs
- Status last verified
- Aug 2026
- First submitted
- 11 Jul 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Injection of Liquid Phase Concentrated Growth Factor Versus Conventional Arthrocentesis in Management of Temporomandibular Disc Displacement: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07075276
- Acronym / sponsor ID
- LPCGF in TMDs / CGF for management of TMDs
- Conditions
- Temporomandibular Disorders (TMD), Internal Derangement of the Tempromandibular Joint, Anterior Disc Displacement
- Keywords
- Temporomandibular disorder, Concentrated growth factor, Anterior disc displacement with reduction, Anterior disc displacement without reduction, Arthrocentesis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Horus UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 20 Jul 2025 (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 aims to rigorously assess the effectiveness of LPCGF in the management of internal disc displacement in patients with TMD through a randomized clinical trial. By comparing LPCGF therapy with conventional arthrocentesis, this research looks to provide robust evidence on the efficacy, safety, and potential role of (LPCGF) as an alternative therapeutic choice for IDD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 16 patients with anterior disc displacement with or without reduction will be treated with liquid phase concentrated growth factor and 16 patients will be treated with conventional arthrocentesis
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Liquid Phase Concentrated Growth Factor16 patients have anterior disc displacement with or without reduction will be treated with injection of liquid phase concentrated growth factor |
| Group B | Active comparator | Procedure: Conventional arthrocentesis16 patients have anterior disc displacement with or without reduction will be treated with conventional arthrocentesis |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Adults aged 18-45 years. 2. Patients scored as (ASA I).9 3. Presence of complete or nearly complete set of natural dentition with Angle class I occlusion. 4. Diagnosed with unilateral involvement of disc displacement, according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD).10 5. Symptoms include one or more of the following: pain, joint sounds, and limited mandibular movement (Maximum Mouth Opening< 40mm) 6. No prior surgical intervention for TMD. 7. Patient's willingness to participate and follow the study protocol.
Key exclusion criteria (1 listed)
- 1. TMJ pathology related to mechanical deformities 2. Psychiatric problems or presence of systemic diseases that may affect healing (e.g., uncontrolled diabetes, autoimmune disorders, hematologic or neurologic disorders, inflammatory or connective tissue disorders as well as rheumatological or previous infectious diseases, head and neck cancer). 3. Patient unwilling or has contraindication to MRI 4. Previous injections or surgical interventions of the TMJ. 5. Concurrent use of anticoagulants or anti-inflammatory medications within the last 30 days. 6. Pregnant or breastfeeding women. 7. History of trauma or infection in the TMJ region. 8. Allergy to local anesthetics or other components used in the study. 9. Patients diagnosed with (Disc Displacement with reduction with no pain or limited mandibular movements).
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 |
|---|---|---|
| Liquid Phase Concentrated Growth Factor16 patients with anterior disc displacement with or without reduction randomly allocated to be treated with injection of liquid phase concentrated growth factor | Procedure or surgery | Group A |
| Conventional arthrocentesis16 patients with anterior disc displacement with or without reduction randomly allocated to be treated with conventional arthrocentesis | Procedure or surgery | Group B |
Primary outcome
Assess and comparing the pain of both groups
Time frame: Assessed at baseline (before treatment),1week, 1 month, 3 months, and 6 months after the intervention.
measured using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst pain)
Assess and comparing the mouth opening of both groups
Time frame: Assessed at baseline (before treatment),1week, 1 month, 3 months, and 6 months after the intervention.
measured in millimeters (Maximum inter-incisal opening measured by the distance in millimeters between the incisal edges of the upper and lower central incisors in vertical direction at maximum pain free mouth opening) by using caliper. and comparing the results of both groups
5 secondary outcomes
Joint sounds
Time frame: Assessed at baseline (before treatment),1week, 1 month, 3 months, and 6 months after the intervention.
Mandibular deviation during mouth opening.
Time frame: Assessed at baseline (before treatment),1week, 1 month, 3 months, and 6 months after the intervention.
Lateral and protrusive movements
Time frame: Assessed at baseline (before treatment),1week, 1 month, 3 months, and 6 months after the intervention
tenderness on palpation
Time frame: Assessed at baseline (before treatment),1week, 1 month, 3 months, and 6 months after the intervention.
TMD symptoms
Time frame: Assessed at baseline (before treatment),1week, 1 month, 3 months, and 6 months after the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- 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.
Mohamed Ali Habib, Teaching Assistant principal investigator
Horus University in Egypt - Faculty of dentistry
Eman AbdElsalam Yousef, Ass. prof study director
Horus University in Egypt- Faculty of dentistry
Ahmed Khalil, lecturer study director
Horus University in Egypt - Faculty of dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liquid Phase Concentrated Growth Factor and Conventional arthrocentesis in people with Temporomandibular Disorders (TMD) and Internal Derangement of the Tempromandibular Joint, run by Horus 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 1 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: looking for participants now, as of the sponsor's last update on 17 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Ali Habib, Teaching assistant (+2001069505336, mbasiouny@horus.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess and comparing the pain of both groups (time frame: Assessed at baseline (before treatment),1week, 1 month, 3 months, and 6 months after the intervention.). 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?
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 17 Aug 2026.