Temporomandibular Joint Disorders, Articular Disc Disorder (Reducing or Non-Reducing)NCT06937151
Comparison Between Arthrocentesis and Rocabado Exercises on Temporomandibular Disc Displacement Without Reduction
A study testing Rocabado approach exercise program 6×6 and manibulation . and Arthrocentesis in people with Temporomandibular Joint Disorders, Articular Disc Disorder (Reducing or Non-Reducing), run by Cairo University at 2 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Joint Disorders, Articular Disc Disorder (Reducing or Non-Reducing)
- What is being tested?
- Rocabado approach exercise program 6×6 and manibulation . and Arthrocentesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 2 sitesEgypt
- Study dates
- 3 Sep 2022to 2 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- History of major jaw trauma.
- Dentofacial deformity.
- Psychiatric illness.
- Chronic headache. Presence of other disorders involving the TMJ.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Kafer Shoukr Spechialized Hospital
Banhā, Banha, 13715
Kafer Shoukr Spechialized Hospital
Banhā, Qalubiah, 13715
About this study
Official title: 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.
Read the 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:
- 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.
- 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
- Being tested
- Rocabado approach exercise program 6×6 and manibulation ., Arthrocentesis
- Keywords
- Temporomandibular Joint Disorders
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rocabado approach exercise program 6×6 and manibulation .Procedure or surgery
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.
ArthrocentesisProcedure or surgery
Also called TMJ joint washing
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Arthrocentesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: pre treatment and eight weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start3 Sep 2022
- Primary completion2 Mar 2024
- Study completion2 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint Disorders, Articular Disc Disorder (Reducing or Non-Reducing)Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Shawkey Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06937151
- Sponsor's protocol ID
- P.T.REC/012/003932
- Status last verified
- Apr 2025
- First submitted
- 3 Dec 2023
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthrocentesis Versus Rocabado Exercises on Temporomandibular Disc Displacement Without Reduction
- ClinicalTrials.gov ID
- NCT06937151
- Acronym / sponsor ID
- P.T.REC/012/003932
- Keywords
- Temporomandibular Joint Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Sep 2022 (actual)
- Primary completion
- 2 Mar 2024 (actual)
- Study completion
- 2 May 2024 (actual)
- First posted
- 22 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Study group) ROCABADO APPROACH : | Active comparator | Procedure: Rocabado approach exercise program 6×6 and manibulation .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 |
| Group B (Control group) ARTHOROCENTESIS: | Active comparator | Procedure: ArthrocentesisThis group includes thirty-four patients with temporomandibular joint disc displacement without reduction who will receive TMJ Arthrocentesis |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- History of major jaw trauma.
- Dentofacial deformity.
- Psychiatric illness.
- Chronic headache. Presence of other disorders involving the TMJ.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Group A (Study group) ROCABADO APPROACH : |
| ArthrocentesisAlso: TMJ joint washingParticipants 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. | Procedure or surgery | Group B (Control group) ARTHOROCENTESIS: |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rocabado approach exercise program 6×6 and manibulation . and Arthrocentesis in people with Temporomandibular Joint Disorders, Articular Disc Disorder (Reducing or Non-Reducing), run by Cairo University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thera Bite RANGE OF MOTION scale (time frame: pre treatment and eight weeks post treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2025.