Comparison Between Arthrocentesis and Rocabado Exercises on Temporomandibular Disc Displacement Without Reduction

Arthrocentesis Versus Rocabado Exercises on Temporomandibular Disc Displacement Without Reduction

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.

Study Overview

• Status: Completed
• Conditions: Temporomandibular Joint Disorders, Articular Disc Disorder (Reducing or Non-Reducing)
• Intervention / Treatment: Procedure: Rocabado approach exercise program 6×6 and manibulation .; Procedure: Arthrocentesis

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

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Banha
    • Banhā, Banha, Egypt, 13715
      • Kafer Shoukr Spechialized Hospital
  • Qalubiah
    • Banhā, Qalubiah, Egypt, 13715
      • Kafer Shoukr Spechialized Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A (Study group) ROCABADO APPROACH : Group A (Study group): This group includes thirty-four patients with temporomandibular joint disc displacement without reduction, who will receive the Rocabado approach exercise program 6×6 AND MANIPULATION	Procedure: Rocabado approach exercise program 6×6 and manibulation .; Rocabado's approach (Rocabado's 6 × 6 Exercises and manipulation). This program included 6 exercises to be performed 6 times a day, repeated 6 times, and three gliding exercises.
Active Comparator: Group B (Control group) ARTHOROCENTESIS: This group includes thirty-four patients with temporomandibular joint disc displacement without reduction who will receive TMJ Arthrocentesis	Procedure: Arthrocentesis; Participants in the Control Group underwent arthrocentesis of the affected temporomandibular joint. The procedure was performed as follows: Anesthesia: Local anesthesia was administered to the area surrounding the TMJ. Needle Insertion: A 20-gauge needle was inserted into the upper joint space approximately 10 mm anterior to the tragus. Lavage: The joint was lavaged with lactated Ringer's solution to reduce inflammation and remove debris. The joint was irrigated with lactated Ringer's solution.; Other Names: TMJ joint washing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thera Bite RANGE OF MOTION scale	Will be used for measuring the Maximal interincisal opening, lateral movement will be measured. Measuring Maximal Interincisal Opening : Patient Positioning: The patient opens their mouth as wide as possible without discomfort.; Scale Placement: The range of motion scale is positioned so that the notch rests on the edge of the lower incisor.; Measurement: Rotate the scale until it contacts the upper incisor, and record the reading at the point of contact. Measuring Lateral Excursion Movement: Scale Alignment: Rest the range of motion scale against the lower incisors with the upper and lower teeth closed together.; Arrow Alignment: Align the arrow on the scale with an interproximal space between two upper teeth.; Measurement: Move the mandible laterally (side-to-side) and record the measurements on the lateral side.	pre treatment and eight weeks post treatment
8-Items Jaw Functional Limitation Scale	Disability related to orofacial pain, which makes it a generic tool that one can use it for different types of orofacial pain conditions.; Preparation: Select a quiet and distraction-free environment.; Understanding the Scale: Rate each item on a scale from 0 (no limitation) to 10 (severe limitation).; Completing the Questionnaire: Carefully read each question and reflect on your jaw function over the past week.; Items to Rate: Assess difficulties in chewing, mouth opening, and emotional expression.; Time Required: Completion typically takes less than 5 minutes.; Post-Completion: Higher scores indicate greater functional limitations.	pre treatment and eight weeks post treatment
Visual analog scale	One of the pain rating scales,; Preparation: Ensure the VISUAL ANALOG SCALE line is accurately printed to scale (10 cm) with endpoints labeled:0 = No pain.10 = Worst imaginable pain.; Patient Instructions: Ask the patient to mark their current pain level on the line.; Score Measurement and Interpretation: Measure the distance in centimeters from the "no pain" end (0) to the patient's mark to determine the score out of 10. Higher scores indicate greater pain intensity (e.g., a mark at 6 cm corresponds to a pain level of 6/10).; Recall Period: Patients report either their current pain or pain experienced within the last 24 hours, depending on assessment context.	pre treatment and eight weeks post treatment

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2022
• Primary Completion (Actual): March 2, 2024
• Study Completion (Actual): May 2, 2024

Study Registration Dates

• First Submitted: December 3, 2023
• First Submitted That Met QC Criteria: April 17, 2025
• First Posted (Actual): April 22, 2025

Study Record Updates

• Last Update Posted (Actual): April 22, 2025
• Last Update Submitted That Met QC Criteria: April 17, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Temporomandibular Joint Disorders
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Muscular Diseases; Jaw Diseases; Mandibular Diseases; Craniomandibular Disorders; Myofascial Pain Syndromes; Joint Diseases; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
• Other Study ID Numbers: P.T.REC/012/003932

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No