TMJ Disc Displacement With ReductionNCT07115797
ARS vs ARS With Arthrocentesis and PRP Injection in DDWR
A study testing arthrocentesis - PRP injection -ARS and ARS in people with TMJ Disc Displacement With Reduction and TMD, run by Cairo University.
Trial summary
This study will be conducted to assess the effect of anterior repositioning splint and arthrocentesis with platelet-rich plasma injection compared to anterior repositioning splint only, in TMD patients with anterior disc displacement with reduction Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- TMJ Disc Displacement With Reduction, TMD, PRP Injection
- What is being tested?
- arthrocentesis - PRP injection -ARS and ARS
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Oct 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients suffering from internal derangement anterior disc displacement
- Mouth Opening: Limited range of motion or difficulty with full mouth opening
- Symptoms: Patients who report typical symptoms of TMJ dysfunction, such as pain, discomfort, or clicking sounds in the joint, especially when opening or closing the mouth.
- Clicking: Audible clicking.
- Pain: Pain or tenderness around the TMJ, often radiating to the ear, temple, or neck.
Who cannot join
- Blood dyscrasias and Uncontrolled systemic diseases.
- Rheumatoid Arthritis.
- Infection in the pre-auricular area.
About this study
Official title: Anterior Repositioning Splint With or Without Arthrocentesis and Platelet-rich Plasma Injection In TMD Patients With Anterior Disc Displacement With Reduction: A Randomized Controlled Clinical Trial
This study will be conducted to assess the effect of anterior repositioning splint and arthrocentesis with platelet-rich plasma injection compared to anterior repositioning splint only, in TMD patients with anterior disc displacement with reduction
Read the detailed description
Anterior repositioning splint (ARS) allows the mandible to assume an anterior position to centric occlusion, providing a more favorable condyle-disc relationship in the fossa so that normal function can be established. The goal is to eliminate the signs and symptoms associated with disc-interference disorders. Maintaining the mandible in a temporary therapeutic position in which click is eliminated and thereby allowing the disc to reposition
A study by (Mohamed \& Abd el Azizi, 2021) Found that ARS showed a significant reduction of pain and increase in maximum mouth opening after 1 month and an increase in MMO. Platelet-rich plasma (PRP) is a therapeutic agent consisting essentially of a platelet concentrate and associated growth factors taken and centrifuged from a sample of the patient's blood. It was initially introduced in the fields of stomatology, maxillofacial/plastic surgery, and reconstructive surgery in the 1990s and its clinical use is due to its potential healing properties through cell recruitment, proliferation, differentiation, and consequently, tissue remodeling. It has been found to have several advantages over the use of corticosteroids in the treatment of TMJ degenerative and inflammatory conditions, the most remarkable being its lack of serious and/or irreversible adverse effects. Treatment with PRP injections has reported anti-inflammatory, analgesic and antibacterial properties and, at the same time, restores intra-articular levels of hyaluronic acid, increases glycosaminoglycan chondrocyte synthesis, balances joint angiogenesis, and induces stem cell migration.
Explanation for choice of comparators:
Anterior repositioning splint (ARS) therapy is a common conservative method for treating disc-displacement-related (TMDs). ARS can be fixed on the maxilla or mandible and it usually maintains the protrusion status through an anterior guidance ramp The protrusion of the mandible changes the disc condyle relationship and is widely used in intra-articular TMD treatment. This method can significantly improve pain symptoms. Thus, it can also be used in pain-related TMDs.
- Conditions
- TMJ Disc Displacement With Reduction, TMD, PRP Injection
- Being tested
- arthrocentesis - PRP injection -ARS, ARS
- Keywords
- ARS-PRP-Arthrocentsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arthrocentesis - PRP injection -ARSOther
oarthrocentesis then PRP injection and then ARS
ARSOther
Insertion Of ARS Only
| Study group | Role | What they receive |
|---|---|---|
| Comparator | Active comparator | ARS Receives: Other: ARS |
| intervention | Active comparator | arthrocentesis then PRP injection and then ARS Receives: Other: arthrocentesis - PRP injection -ARS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum pain-free interincisal opening measured in mm by caliper
Measured: from enrollment to the end of study at 6 months
Secondary outcomes (1)
Pain measured by VAS scale
Measured: from enrollment to the end of study at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study startSep 2025 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMJ Disc Displacement With ReductionStudies of the same condition, open and under way.
- More trials run by Cairo 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Saleh Thabit Ali, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07115797
- Sponsor's protocol ID
- ARS+- PRP & Arthrocentesis
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior Repositioning Splint With or Without Arthrocentesis and Platelet-rich Plasma Injection In TMD Patients With Anterior Disc Displacement With Reduction: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07115797
- Acronym / sponsor ID
- ARS+- PRP & Arthrocentesis
- Conditions
- TMJ Disc Displacement With Reduction, TMD, PRP Injection
- Keywords
- ARS-PRP-Arthrocentsis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 11 Aug 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 will be conducted to assess the effect of anterior repositioning splint and arthrocentesis with platelet-rich plasma injection compared to anterior repositioning splint only, in TMD patients with anterior disc displacement with reduction
Detailed description
Anterior repositioning splint (ARS) allows the mandible to assume an anterior position to centric occlusion, providing a more favorable condyle-disc relationship in the fossa so that normal function can be established. The goal is to eliminate the signs and symptoms associated with disc-interference disorders. Maintaining the mandible in a temporary therapeutic position in which click is eliminated and thereby allowing the disc to reposition
A study by (Mohamed \& Abd el Azizi, 2021) Found that ARS showed a significant reduction of pain and increase in maximum mouth opening after 1 month and an increase in MMO. Platelet-rich plasma (PRP) is a therapeutic agent consisting essentially of a platelet concentrate and associated growth factors taken and centrifuged from a sample of the patient's blood. It was initially introduced in the fields of stomatology, maxillofacial/plastic surgery, and reconstructive surgery in the 1990s and its clinical use is due to its potential healing properties through cell recruitment, proliferation, differentiation, and consequently, tissue remodeling. It has been found to have several advantages over the use of corticosteroids in the treatment of TMJ degenerative and inflammatory conditions, the most remarkable being its lack of serious and/or irreversible adverse effects. Treatment with PRP injections has reported anti-inflammatory, analgesic and antibacterial properties and, at the same time, restores intra-articular levels of hyaluronic acid, increases glycosaminoglycan chondrocyte synthesis, balances joint angiogenesis, and induces stem cell migration.
Explanation for choice of comparators:
Anterior repositioning splint (ARS) therapy is a common conservative method for treating disc-displacement-related (TMDs). ARS can be fixed on the maxilla or mandible and it usually maintains the protrusion status through an anterior guidance ramp The protrusion of the mandible changes the disc condyle relationship and is widely used in intra-articular TMD treatment. This method can significantly improve pain symptoms. Thus, it can also be used in pain-related TMDs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comparator | Active comparator | Other: ARSARS |
| intervention | Active comparator | Other: arthrocentesis - PRP injection -ARSarthrocentesis then PRP injection and then ARS |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients suffering from internal derangement anterior disc displacement
- Mouth Opening: Limited range of motion or difficulty with full mouth opening
- Symptoms: Patients who report typical symptoms of TMJ dysfunction, such as pain, discomfort, or clicking sounds in the joint, especially when opening or closing the mouth.
- Clicking: Audible clicking.
- Pain: Pain or tenderness around the TMJ, often radiating to the ear, temple, or neck.
Key exclusion criteria (3 listed)
- Blood dyscrasias and Uncontrolled systemic diseases.
- Rheumatoid Arthritis.
- Infection in the pre-auricular area.
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 |
|---|---|---|
| arthrocentesis - PRP injection -ARSoarthrocentesis then PRP injection and then ARS | Other | intervention |
| ARSInsertion Of ARS Only | Other | Comparator |
Primary outcome
Maximum pain-free interincisal opening measured in mm by caliper
Time frame: from enrollment to the end of study at 6 months
1 secondary outcome
Pain measured by VAS scale
Time frame: from enrollment to the end of study at 6 months
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 11 Aug 2025.
Related trials for TMJ Disc Displacement With Reduction
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
Active, not recruitingPhase 2
Assessment of Injectable PRF Versus Dextrose Injection in Temporomandibular Joint in Anterior Disc Displacement With Reduction
TMD
Recruiting
Liquid Phase Concentrated Growth Factor Versus Conventional Arthrocentesis in Temporomandibular Disc Displacement
Temporomandibular Disorders (TMD), Internal Derangement of the Tempromandibular Joint
RecruitingObservational study
Long-term Follow up of TMJ Surgery and Evaluation of the 6-month Control as a Prognostic Marker.
Temporomandibular Disorders (TMD), Temporomandibular Joint Disc Displacement, With Reduction
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing arthrocentesis - PRP injection -ARS and ARS in people with TMJ Disc Displacement With Reduction and TMD, run by Cairo University.
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 3 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: opening soon, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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 pain-free interincisal opening measured in mm by caliper (time frame: from enrollment to the end of study at 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 11 Aug 2025.