Clinical trial NCT06244134: Ultrasound Guided Autologous Blood Injection in Temporomandibular Joint Dislocation
Official title: Ultrasound -Guided Versus Conventional Non Guided Autologous Blood Injection For Treatment of Patients With Chronic Recurrent Temporomandibular Joint Dislocation. A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Temporomandibular Joint Dislocation
Keywords: ultrasound
autologous blood
temporomandibular joint
dislocation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 24
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 this study is To compare the accuracy and effectiveness of ultrasound (US) guided autologous blood injection (ABI) versus non- guided technique for the treatment of chronic recurrent temporomandibular joint dislocation

Detailed description: All patients involved in this study will be divided randomly to two different groups and injected with autologous blood into joint space and pericapsular tissue.

Study group (group A) will be injected with autologous blood with ultrasound guidance.

control group (group B) will be injected with autologous blood without US guidance. Anatomical landmarks and tactical sense will be followed only.

The operation will be done under local anesthesia ( Auriculotemporal nerve block ) the skin overlying the temporomandibular joint will be scrubbed by an antiseptic solution and the area will be isolated with sterile towels. External auditory canal will be blocked with cotton.

About 3 ml of blood will be withdrawn from patient's antecubital fossa, of which 2 ml injected intra-articular and 1 ml in the pericapsular tissue (PT) The procedure should be repeated on the opposite side in case of bilateral involvement.

Eligibility criteria: Inclusion Criteria:

* Patient with at least 3 episodes of temporomandibular joint dislocation in the past 6 months.
* Necessitating a visit to the emergency room or trained professional to reduce the dislocation.
* Radiological evidence of displacement of condylar head beyond the articular eminence on wide mouth opening.
* Maximum mouth opening (MMO) more than 40 mm.
* Unilateral or bilateral.
* Over 18 years of age.
* Both gender Males or females.

Exclusion Criteria:

* Patient having inflammatory temporomandibular joint disease like tuberculous arthritis, rheumatoid arthritis.
* Patients with bleeding disorders, pregnancy or bony pathology of temporomandibular joint .
* Allergy to local anesthetic.
* Severe epilepsy or Parkinson's disease.
* Patient on anti-depressants or anti-psychotics.
* Inability to follow-up the patient during the entire follow-up period.
* Patients who had recent fracture at temporomandibular joint level or who had previous surgical interference to temporomandibular joint .
* Refused to sign the written informed consent were also excluded.
* Dystonia

Primary outcomes:
measure: maximum mouth opening
timeFrame: at 2weeks, 3months and 6 months post-operative
Secondary outcomes:
measure: Frequency of temporomandibular joint dislocation:
timeFrame: 2weeks, 3 months and 6 months post-operatively
measure: change of pain
timeFrame: 2weeks, 3 months and 6 months post-operatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: faculty of dentistry, Cairo university
Study officials:
References:
citation: Gagnani SP, Kholakiya YR, Arora A, Bhutia O, Seith A, Khandelwal RK, Roychoudhury A. Ultrasound-guided autologous blood injection in patients with chronic recurrent temporomandibular joint dislocation. Natl J Maxillofac Surg. 2020 Jan-Jun;11(1):34-39. doi: 10.4103/njms.NJMS_57_18. Epub 2020 Jun 18.
citation: Pandey SK, Baidya M, Srivastava A, Garg H. Comparison of autologous blood prolotherapy and 25% dextrose prolotherapy for the treatment of chronic recurrent temporomandibular joint dislocation on the basis of clinical parameters: A retrospective study. Natl J Maxillofac Surg. 2022 Sep-Dec;13(3):398-404. doi: 10.4103/njms.njms_509_21. Epub 2022 Dec 10.