Temporomandibular Disorders (TMDs)
Conditions
Keywords
TMJ subluxation, Temporomandibular joint subluxation, TMJ hypermobility, Recurrent TMJ dislocation, Platelet-rich plasma, PRP prolotherapy
Brief 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. 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.
Interventions
PROCEDURELow Platelet Concentration PRP (L-PRP)
Intra-articular and pericapsular injection of platelet-rich plasma prepared with Low platelet concentration..
PROCEDUREHigh Platelet Concentration PRP (L-PRP)
Intra-articular and pericapsular injection of platelet-rich plasma prepared with high platelet concentration.
Sponsors
IBB University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants and outcome assessors were blinded to group allocation. The clinician performing the intervention was not blinded due to the nature of the procedure.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
patients aged ≥ 18 years -
Exclusion criteria
patients aged \< 18 years \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TMJ Pain on Function | 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 | Baseline, 6 months, and 5 years | Frequency of locking, expressed as number of episodes per day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum mouth opening (MMO) | Baseline, 6 months, and 5 years | MMO measured as the distance in mm between the incisal edges of the upper and lower central incisors using a ruler. |
| Presence of joint clicking | Baseline, 6 months, and 5 years | TMJ clicking, recorded as present or absent based on periauricular palpation during mandibular movement. |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORHamida Refai, PhD
Cairo University
Outcome results
None listed