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

NCT06937151 | Completed

• 1 other identifier: P.T.REC/012/003932
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 2

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.

Conditions

Temporomandibular Joint Disorders, Articular Disc Disorder (Reducing or Non-Reducing)

Keywords

Temporomandibular Joint Disorders

Outcome Measures

Primary Outcomes (3)

• Thera Bite RANGE OF MOTION scale

  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

  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

  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

Study Arms (2)

Group A (Study group) ROCABADO APPROACH :

ACTIVE COMPARATOR

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 .

Group B (Control group) ARTHOROCENTESIS:

ACTIVE COMPARATOR

This group includes thirty-four patients with temporomandibular joint disc displacement without reduction who will receive TMJ Arthrocentesis

Procedure: Arthrocentesis

Interventions

Rocabado approach exercise program 6×6 and manibulation . PROCEDURE

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.

Group A (Study group) ROCABADO APPROACH :

Arthrocentesis PROCEDURE

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.

Also known as: TMJ joint washing

Group B (Control group) ARTHOROCENTESIS:

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (2)

Kafer Shoukr Spechialized Hospital

Banhā, Banha, 13715, Egypt

Location

Kafer Shoukr Spechialized Hospital

Banhā, Qalubiah, 13715, Egypt

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Arthrocentesis

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Paracentesis; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist

Study Record Dates

• First Submitted: December 3, 2023
• First Posted: April 22, 2025
• Study Start: September 3, 2022
• Primary Completion: March 2, 2024
• Study Completion: May 2, 2024
• Last Updated: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)