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

April 17, 2025 updated by: Eman Shawkey Mohamed, Cairo University

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: pre treatment and eight weeks post treatment

Will be used for measuring the Maximal interincisal opening, lateral movement will be measured.

Measuring Maximal Interincisal Opening :

  1. Patient Positioning: The patient opens their mouth as wide as possible without discomfort.
  2. Scale Placement: The range of motion scale is positioned so that the notch rests on the edge of the lower incisor.
  3. Measurement: Rotate the scale until it contacts the upper incisor, and record the reading at the point of contact.

Measuring Lateral Excursion Movement:

  1. Scale Alignment: Rest the range of motion scale against the lower incisors with the upper and lower teeth closed together.
  2. Arrow Alignment: Align the arrow on the scale with an interproximal space between two upper teeth.
  3. 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
Time Frame: pre treatment and eight weeks post treatment

Disability related to orofacial pain, which makes it a generic tool that one can use it for different types of orofacial pain conditions.

  1. Preparation: Select a quiet and distraction-free environment.
  2. Understanding the Scale: Rate each item on a scale from 0 (no limitation) to 10 (severe limitation).
  3. Completing the Questionnaire: Carefully read each question and reflect on your jaw function over the past week.
  4. Items to Rate: Assess difficulties in chewing, mouth opening, and emotional expression.
  5. Time Required: Completion typically takes less than 5 minutes.
  6. Post-Completion: Higher scores indicate greater functional limitations.
pre treatment and eight weeks post treatment
Visual analog scale
Time Frame: pre treatment and eight weeks post treatment

One of the pain rating scales,

  1. Preparation: Ensure the VISUAL ANALOG SCALE line is accurately printed to scale (10 cm) with endpoints labeled:

    • 0 = No pain.
    • 10 = Worst imaginable pain.
  2. Patient Instructions: Ask the patient to mark their current pain level on the line.
  3. 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).
  4. 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

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe