Anterior Disc Displacement, Internal Derangement, Temporomandibular Disorder (TMD)
Conditions
Keywords
temporomandibular disorder, intra-articular injection, internal derangement, anterior disc displacement, computer-assisted, Computer-aided design, computer-aided manufacturing, software, shepard cannula
Brief summary
The intra-articular injection is considered the first line of minimally invasive treatment in temporomandibular joint with internal derangement (TMJ-ID) patients who do not respond to conservative treatment. The single-needle technique arthrocentesis has emerged to add reliability, convenience, ease the performance of the procedure, and eliminate the need for multiple punctures the Aim of this study is to assess clinical applicability and therapeutic outcomes of computer guided single needle arthrocentesis with platelet rich plasma using Shepard's cannula, in comparison with conventional free-hand technique, in the management of disc displacement with reduction of the TMJ.
Detailed description
A total of 24 patients with a magnetic resonance imaging (MRI) diagnosis of reducing disc displacement will be included and assigned randomly into one of two groups. Computer-guided arthrocentesis with PRP will be performed on patients in the study group using the single needle technique by Shepard cannula technique; while the conventional free hand technique will be performed in the control group. Procedure-related parameters will be assessed, while Clinical evaluation will be conducted on day 1, 1 and 3 months postoperatively.
Interventions
DEVICEComputer-guided single needle arthrocentesis
Patients with TMJ ID + reduction managed with computer-guided single needle arthrocentesis in adjunct to PRP intra-articular injection
DEVICEconventional free hand single needle arthrocentesis
Patients with TMJ ID + reduction managed with conventional free hand single needle arthrocentesis in adjunct to PRP intra-articular injection.
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Sequentially numbered, opaque, sealed envelopes (SNOSE) allocation concealment method will be utilized. Each participant included in the study will be given a serial number that will be used in the allocation. These numbers will be written in identical sheets of paper with the group to which each participant is allocated and placed inside opaque envelopes carrying the respective names of participants. A trial independent personnel will be assigned the role of keeping the envelopes and unfolding them only at the time of the operation, so that the participant is allocated to a group which is concealed from the operator
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients diagnosed with internal derangement according to Wilkes stage I and II. 2. Adult patients above 18 years old. 3. Patients who would not respond to conservative treatment as a first line of treatment
Exclusion criteria
1. Patients with Wilkes stage III, IV, V. 2. Patients suffering from any systemic diseases, platelets function disorders, fibrinogen deficiency. 3. History of mandibular fracture. 4. Lactating, pregnant or planning pregnancy women. 5. Patients receiving anticoagulation treatment or NSAIDS within 48 hours preoperatively, corticosteroid injection at treatment site within 1 month or systemic use of corticosteroids within 2 weeks.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| objective assessment of joint function and mandibular excursion | 3 months | Clinical evaluation will be based on the Helkimo's clinical dysfunction index (Di), which is a part of the Helkimo index that provides an objective assesment of joint function and mandibular excursion. All patients will be assessed immediately post-operative, 1 and 3 months. Postoperative clinical evaluation values will be compared to the preoperative baseline preoperative values. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of the Operation | intraoperative | Total procedural time consumed starting from the application of topical antiseptic up to the end of the procedure will be measured and compared between both groups. In the Computer-Guided group, the time for needle injection will be further computed to determine the actual injection time in the procedure bar from the guide installation time and patient preparation. |
Countries
Egypt
Outcome results
None listed