Clinical trial NCT06937151: Comparison Between Arthrocentesis and Rocabado Exercises on Temporomandibular Disc Displacement Without Reduction
Official title: Arthrocentesis Versus Rocabado Exercises on Temporomandibular Disc Displacement Without Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Joint Disorders, Articular Disc Disorder (Reducing or Non-Reducing)
Keywords: Temporomandibular Joint Disorders
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-04-22
Enrollment: 68
Sex: ALL
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study will be designed to compare the short- and medium-term results of arthrocentesis and non-surgical methods Rocabado approach in early disc displacement without reduction.

Detailed description: This study will be designed to provide a comparison between the effect of the Rocabado approach as a conservative treatment and temporomandibular joint arthrocentesis in temporomandibular joint disc displacement without reduction.

Delimitations:

This study will be delimited in the following aspects:

1. Patients:

   The study group will be composed of sixty-eight patients with temporomandibular joint disc displacement without reduction will be enrolled in the study. Group A: It will be composed of thirty-four patients with TMJ disc displacement without reduction who are started on the Rocabado approach- 4 - 6×6 exercise program. Include therapeutic exercise, and patient education focusing on the temporomandibular joint. Repeat measurements will be performed on 1st measurement at the baseline before any intervention, 2nd measurement after 8 weeks of treatment by a physiotherapist. Group B: It will be composed of thirty-four patients with disc displacement without reduction who are started on TMJ arthrocentesis procedure with medical and nursing care.
2. Equipment and tools:

2.1-Measurement equipment: Thera bite ROM scale 8-Item Jaw Functional Limitation Scale (JFLS-8) (Valid Arabic version) visual anlogue scale 2.2-Therapeutic procedures: Rocabado's 6X6 Exercise Program and manibulation

Eligibility criteria: Inclusion Criteria:

* History of a sudden reduction in the mandibular opening. Unassisted mandibular opening 35 mm.
* Mandibular opening with assistance increased by ≥3 mm from
* unassisted opening, with a prior history of click, click disappearance, and a sudden decrease in opening.
* Magnetic resonance imaging (MRI) diagnosis of Disc displacement without reduction.
* Persistence of the symptoms indicated in the first item for a Maximum of 3 weeks.
* clinical diagnosis of unilateral Disc displacement without reduction of the temporomandibular joint.

Exclusion Criteria:

* History of major jaw trauma.
* Dentofacial deformity.
* Psychiatric illness.
* Chronic headache. Presence of other disorders involving the TMJ.

Primary outcomes:
measure: Thera Bite RANGE OF MOTION scale
timeFrame: pre treatment and eight weeks post treatment
measure: 8-Items Jaw Functional Limitation Scale
timeFrame: pre treatment and eight weeks post treatment
measure: Visual analog scale
timeFrame: pre treatment and eight weeks post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Kafer Shoukr Spechialized Hospital
state: Banha
city: Banhā
country: Egypt
facility: Kafer Shoukr Spechialized Hospital
state: Qalubiah
Study officials:
References: