Clinical trial NCT06132594: Computed Guided Prolotherapy Versus Conventional Prolotherapy
Official title: Computed Guided Prolotherapy Versus Conventional Prolotherapy in Treatment of TMJ Internal Derangment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Joint Disorders
Orofacial Pain
Keywords: TMD
Temporomandibular Joint Disorders
Prolotherapy of TMJ
Guided Arthrocentesis
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2023-11-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of that study is to compare between conventional prolotherapy and computed guided prolotherapy in treatment of temporomandibular joint (TMJ) internal derangement.

Detailed description: This study will include patients with TMJ internal derangement with signs and symptoms of pain, clicking and limited mouth opening .The study will be held in oral and maxillofacial department, Faculty of Dental Medicine, Al-Azhar University, Assiut branch. Internal derangement of the joint will be confirmed by magnetic resonance image (MRI).

Patients included in this study will be divided randomly into two equal groups by the aid of financial coins. Group I: patients will be conventionally injected into the superior space of TMJ by injectable PRF by the aid of the surface facial landmarks where the patient will seated comfortably at 45° angle on the dental chair with the head turned toward the unaffected side. The target site will be prepared and disinfected with betadine. The points of needle insertion will be marked on the skin according to a line will be draw from the middle of the tragus of the ear to the outer canthus of the eye and entry points will be marked along this cantho-tragal line which will correspond to the glenoid fossa and will be marked 10 mm from the mid-tragus and 2 mm below the line.

Group II: patients will be injected into the superior space of TMJ with I- PRF by the aid of specific CT-planned 3D-printed surgical guide, which will lead the needle insertion, and the accuracy of the needle insertion into the superior space of the TMJ will be assessed.

Preparation of I-PRF:

The cubital area of the patient arm will be disinfected with betadine and the blood will be drawn from the patient cubital vein into plain tubes (vaccutainers) under aseptic conditions .The loaded tubes will be centrifuged at 750 rpm for 3 minutes and the I-PRF will be aspirated into a plastic syringe to be ready for injection into the superior space of the TMJ of patients of each group.

Eligibility criteria: Inclusion Criteria:

* Bilateral or unilateral TMJ internal derangement.
* No response to conservative treatments (soft diet, occlusal splint, muscle relaxants, non-steroidal anti-inflammatory drugs, or movement restriction).
* Ability to undergo MRI or CT scans without contraindications.

Exclusion Criteria:

* Those with systemic diseases (polyarthritis or rheumatoid diseases).
* Individuals with neurologic disorders.
* Patients with a history of condylar fracture or previous TMJ injections.
* Those with head and neck cancer.
* Completely edentulous patients (lacking teeth).
* Individuals with implanted metal or medical devices.
* Patients with developmental and congenital disorders of the TMJ.

Primary outcomes:
measure: Assessment of Pain
timeFrame: Intraoperative,1 week, 1month and 3 months
measure: The number of needle insertion attempts
timeFrame: Intraoperative
Secondary outcomes:
measure: Maximal incisal opening
timeFrame: 1 week, 1month and 3 months
measure: Time of operation
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Assuit
country: Egypt
facility: Faculty of Dental Medicine - Al-Azhar University
Study officials:
References:
citation: Young AL. Internal derangements of the temporomandibular joint: A review of the anatomy, diagnosis, and management. J Indian Prosthodont Soc. 2015 Jan-Mar;15(1):2-7. doi: 10.4103/0972-4052.156998.
citation: Laskin DM. Arthroscopy Versus Arthrocentesis for Treating Internal Derangements of the Temporomandibular Joint. Oral Maxillofac Surg Clin North Am. 2018 Aug;30(3):325-328. doi: 10.1016/j.coms.2018.04.008. Epub 2018 Jun 1.
citation: Custodio ALN, Cameron A, Bakr M, Little C, Chrcanovic BR, Reher P. Positioning accuracy assessment of minimally invasive percutaneous injection techniques for the treatment of temporomandibular disorders. Dentomaxillofac Radiol. 2021 Feb 1;50(2):20200313. doi: 10.1259/dmfr.20200313. Epub 2020 Jul 24.
citation: Sivri MB, Ozkan Y, Pekiner FN, Gocmen G. Comparison of ultrasound-guided and conventional arthrocentesis of the temporomandibular joint. Br J Oral Maxillofac Surg. 2016 Jul;54(6):677-81. doi: 10.1016/j.bjoms.2016.04.004. Epub 2016 Apr 23.
citation: Mahmoud K, Galal N, Ali S, Gibaly A, Elbehairy MS, Mounir M. Computer-Guided Arthrocentesis Using Patient-Specific Guides: A Novel Protocol for Treatment of Internal Derangement of the Temporomandibular Joint. J Oral Maxillofac Surg. 2020 Mar;78(3):372.e1-372.e7. doi: 10.1016/j.joms.2019.10.005. Epub 2019 Oct 15.
citation: Hyder A, Tawfik BE, Elmohandes W. Efficacy of computer-guided versus conventional sodium hyaluronate injection in superior joint space in treatment of temporomandibular joint (TMJ) internal derangement: Comparative randomized controlled trial. J Stomatol Oral Maxillofac Surg. 2022 Oct;123(5):e321-e326. doi: 10.1016/j.jormas.2022.05.007. Epub 2022 May 8.