Temporomandibular Disorders (TMDs)PRPTMJNCT07532798
Impact of Platelet Concentration in PRP on TMJ Subluxation
A study testing Low Platelet Concentration PRP (L-PRP) and High Platelet Concentration PRP (L-PRP) in people with Temporomandibular Disorders (TMDs), run by IBB University at 1 site in Egypt.
Trial summary
This study is about a treatment for a jaw condition called temporomandibular joint (TMJ) subluxation. In this condition, the jaw can move too far forward during mouth opening, which may cause repeated jaw locking and problems with normal function. The treatment being studied is platelet-rich plasma (PRP) injections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Temporomandibular Disorders (TMDs)
- What is being tested?
- Low Platelet Concentration PRP (L-PRP) and High Platelet Concentration PRP (L-PRP)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2016to Jul 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Cairo University
Cairo
About this study
Official title: Effect of Platelet Concentration in Platelet-Rich Plasma on Prolotherapy Outcomes in Temporomandibular Joint Subluxation: A Double-Blinded Randomized Clinical Trial
This study is about a treatment for a jaw condition called temporomandibular joint (TMJ) subluxation. In this condition, the jaw can move too far forward during mouth opening, which may cause repeated jaw locking and problems with normal function.
The treatment being studied is platelet-rich plasma (PRP) injections. PRP is made from a person's own blood and may help improve joint stability and reduce symptoms.
Read more
In this study, 40 adults with TMJ subluxation were randomly assigned to receive PRP with either a lower or higher platelet concentration. Each participant received 2 injections, given 2 weeks apart.
The study measured jaw pain, how often locking happened, mouth opening, and joint clicking before treatment, after 6 months, and after 5 years.
The goal of this study is to find out whether the amount of platelets in PRP changes how well this treatment works.
Read the detailed description
This prospective, double-blinded, parallel-group randomized clinical trial was conducted to evaluate whether platelet concentration influences the clinical efficacy of platelet-rich plasma (PRP) prolotherapy in the management of temporomandibular joint (TMJ) subluxation. TMJ subluxation is characterized by recurrent episodes of excessive anterior translation of the mandibular condyle beyond the articular eminence, often resulting in transient jaw locking and functional impairment.
A total of 40 adult patients (≥18 years) diagnosed with TMJ subluxation according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD), supported by imaging evidence, were enrolled and randomly allocated in a 1:1 ratio into two groups: low-concentration PRP (L-PRP) and high-concentration PRP (H-PRP). PRP was prepared using standardized centrifugation protocols (1,500 rpm for L-PRP and 3,200 rpm for H-PRP). All participants received two intra-articular and pericapsular injections separated by a 2-week interval.
The primary outcomes were TMJ pain on function, assessed using a visual analog scale (VAS), and frequency of joint locking (episodes/day). Secondary outcomes included maximal mouth opening (MMO, mm) and presence of joint clicking. Outcomes were assessed at baseline, 6 months, and 5 years following treatment.
The study aimed to determine whether variations in platelet concentration affect clinical outcomes of PRP prolotherapy and to provide evidence for optimizing PRP preparation protocols in the management of TMJ subluxation.
- Conditions
- Temporomandibular Disorders (TMDs)
- Being tested
- Low Platelet Concentration PRP (L-PRP), High Platelet Concentration PRP (L-PRP)
- Keywords
- TMJ subluxation, Temporomandibular joint subluxation, TMJ hypermobility, Recurrent TMJ dislocation, Platelet-rich plasma, PRP prolotherapy
- 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.
Low Platelet Concentration PRP (L-PRP)Procedure or surgery
Intra-articular and pericapsular injection of platelet-rich plasma prepared with Low platelet concentration..
High Platelet Concentration PRP (L-PRP)Procedure or surgery
Intra-articular and pericapsular injection of platelet-rich plasma prepared with high platelet concentration.
| Study group | Role | What they receive |
|---|---|---|
| Low Platelet Concentration PRP (L-PRP) | Active comparator | Patients received prolotherapy using platelet-rich plasma with low platelet concentration. Receives: Procedure: Low Platelet Concentration PRP (L-PRP) |
| High Platelet Concentration PRP (H-PRP) | Active comparator | Patients received prolotherapy using platelet-rich plasma with high platelet concentration. Receives: Procedure: High Platelet Concentration PRP (L-PRP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
TMJ Pain on Function
Pain during jaw function measured using a visual analog scale (VAS) from 0 to 10, where 0 indicates no pain and 10 indicates worst pain.
Measured: Baseline, 6 months, and 5 years
Frequency of TMJ locking
Frequency of locking, expressed as number of episodes per day
Measured: Baseline, 6 months, and 5 years
Secondary outcomes (2)
Maximum mouth opening (MMO)
MMO measured as the distance in mm between the incisal edges of the upper and lower central incisors using a ruler.
Measured: Baseline, 6 months, and 5 years
Presence of joint clicking
TMJ clicking, recorded as present or absent based on periauricular palpation during mandibular movement.
Measured: Baseline, 6 months, and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start1 Apr 2016
- Primary completion1 Jan 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Disorders (TMDs)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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- IBB University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, radwan saleh algabri, IBB University
- Investigators
- Hamida Refai, PhD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07532798
- Sponsor's protocol ID
- CU-TMJ-PRP-RCT-2016
- Acronym
- PRPTMJ
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to institutional regulations and ethical considerations regarding patient confidentiality and data protection.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Platelet Concentration in Platelet-Rich Plasma on Prolotherapy Outcomes in Temporomandibular Joint Subluxation: A Double-Blinded Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07532798
- Acronym / sponsor ID
- PRPTMJ / CU-TMJ-PRP-RCT-2016
- Conditions
- Temporomandibular Disorders (TMDs)
- Keywords
- TMJ subluxation, Temporomandibular joint subluxation, TMJ hypermobility, Recurrent TMJ dislocation, Platelet-rich plasma, PRP prolotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- IBB UniversityUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 16 Apr 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.
This study is about a treatment for a jaw condition called temporomandibular joint (TMJ) subluxation. In this condition, the jaw can move too far forward during mouth opening, which may cause repeated jaw locking and problems with normal function.
The treatment being studied is platelet-rich plasma (PRP) injections. PRP is made from a person's own blood and may help improve joint stability and reduce symptoms.
In this study, 40 adults with TMJ subluxation were randomly assigned to receive PRP with either a lower or higher platelet concentration. Each participant received 2 injections, given 2 weeks apart.
The study measured jaw pain, how often locking happened, mouth opening, and joint clicking before treatment, after 6 months, and after 5 years.
The goal of this study is to find out whether the amount of platelets in PRP changes how well this treatment works.
Detailed description
This prospective, double-blinded, parallel-group randomized clinical trial was conducted to evaluate whether platelet concentration influences the clinical efficacy of platelet-rich plasma (PRP) prolotherapy in the management of temporomandibular joint (TMJ) subluxation. TMJ subluxation is characterized by recurrent episodes of excessive anterior translation of the mandibular condyle beyond the articular eminence, often resulting in transient jaw locking and functional impairment.
A total of 40 adult patients (≥18 years) diagnosed with TMJ subluxation according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD), supported by imaging evidence, were enrolled and randomly allocated in a 1:1 ratio into two groups: low-concentration PRP (L-PRP) and high-concentration PRP (H-PRP). PRP was prepared using standardized centrifugation protocols (1,500 rpm for L-PRP and 3,200 rpm for H-PRP). All participants received two intra-articular and pericapsular injections separated by a 2-week interval.
The primary outcomes were TMJ pain on function, assessed using a visual analog scale (VAS), and frequency of joint locking (episodes/day). Secondary outcomes included maximal mouth opening (MMO, mm) and presence of joint clicking. Outcomes were assessed at baseline, 6 months, and 5 years following treatment.
The study aimed to determine whether variations in platelet concentration affect clinical outcomes of PRP prolotherapy and to provide evidence for optimizing PRP preparation protocols in the management of TMJ subluxation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Platelet Concentration PRP (L-PRP) | Active comparator | Procedure: Low Platelet Concentration PRP (L-PRP)Patients received prolotherapy using platelet-rich plasma with low platelet concentration. |
| High Platelet Concentration PRP (H-PRP) | Active comparator | Procedure: High Platelet Concentration PRP (L-PRP)Patients received prolotherapy using platelet-rich plasma with high platelet concentration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Low Platelet Concentration PRP (L-PRP)Intra-articular and pericapsular injection of platelet-rich plasma prepared with Low platelet concentration.. | Procedure or surgery | Low Platelet Concentration PRP (L-PRP) |
| High Platelet Concentration PRP (L-PRP)Intra-articular and pericapsular injection of platelet-rich plasma prepared with high platelet concentration. | Procedure or surgery | High Platelet Concentration PRP (H-PRP) |
Primary outcome
TMJ Pain on Function
Time frame: Baseline, 6 months, and 5 years
Pain during jaw function measured using a visual analog scale (VAS) from 0 to 10, where 0 indicates no pain and 10 indicates worst pain.
Frequency of TMJ locking
Time frame: Baseline, 6 months, and 5 years
Frequency of locking, expressed as number of episodes per day
2 secondary outcomes
Maximum mouth opening (MMO)
Time frame: Baseline, 6 months, and 5 years
Presence of joint clicking
Time frame: Baseline, 6 months, and 5 years
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 16 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to institutional regulations and ethical considerations regarding patient confidentiality and data protection.
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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.
Hamida Refai, PhD principal investigator
Cairo 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 Low Platelet Concentration PRP (L-PRP) and High Platelet Concentration PRP (L-PRP) in people with Temporomandibular Disorders (TMDs), run by IBB 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 0 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: finished, as of the sponsor's last update on 16 Apr 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?
TMJ Pain on Function (time frame: Baseline, 6 months, and 5 years). 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 16 Apr 2026.