Temporomandibular DisorderNCT06537661
Effect of Virtual Reality on TMD Following Maxillofacial Surgery
A study testing Virtual reality and Traditional exercises in people with Temporomandibular Disorder, run by Cairo University at 2 sites in Egypt.
Trial summary
Sixty eight patients who have TMJ pain and ROM restriction after maxillofacial surgery participated in this study , they are selected from government hospitals (general and insurance ). Will be randomly divided into two equal groups ( group A, group B ). Their ages range from 20 - 35 years. Read more about this study
- Who is it for?
- Ages 30 to 45 years
- Conditions the study is for
- Temporomandibular Disorder
- What is being tested?
- Virtual reality and Traditional exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesEgypt
- Study dates
- 10 Mar 2024to 10 Sep 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 30 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The subject selection will be according to the following criteria:
- Patients after Arthrocentesis .
- Patients after Temporomandibular joint condylar discopexy.
- Age ranges between 30 - 45 years.
- All patients will have informed consent .Exclusion Criteria:
- • Surgery That conducted on the temporomandibular joint (meniscectomy, arthroscopy, etc.).
- oral surgery (e.g., surgery for impaction of the third molar), as well as patients with concomitant systemic or neurological conditions.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: VIRTUAL REALITY and TEMPOROMANDIBULAR DISORDER FOLLOWING MAXILLOFACIAL SURGERY
Sixty eight patients who have TMJ pain and ROM restriction after maxillofacial surgery participated in this study , they are selected from government hospitals (general and insurance ).
Will be randomly divided into two equal groups ( group A, group B ). Their ages range from 20 - 35 years.
The Purpose of the study is to evaluate the therapeutic efficacy of VR in decreasing pain and improve ROM for Patients after maxillofacial surgery.
Read the detailed description
Sixty eight patients who have TMJ pain and ROM restriction after maxillofacial surgery participated in this study , they are selected from government hospitals (general and insurance ).
Will be randomly divided into two equal groups ( group A, group B ). Their ages range from 20 - 35 years.
The VR glasses which were the source of visual and auditory feedback, were connected by Bluetooth to a mobile phone and all the videos of selected tasks (tasks of Active mobility exercises and isometric contraction exercises, massage exercises) were turned on. Active mobility exercises (jaw opening 6 times of 30 s; lateralization 10 times of 5 s; protrusion 10 times Of 5 s).
- Self-massage masticatory Muscles, After each session.
- Isometric contraction exercises The Purpose of the study is to evaluate the therapeutic efficacy of VR in decreasing pain and improve ROM for Patients after maxillofacial surgery.
- Conditions
- Temporomandibular Disorder
- Being tested
- Virtual reality, Traditional exercises
- Keywords
- VR, TMD, Maxillofacial surgery
- 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.
Virtual realityOther
Virtual reality (VR): is the artificial construction of a 3D environment viaThe VR glasses which were the source of visual and auditory feedback, were connected by Bluetooth to a mobile phone and all the videos of selected tasks.
Traditional exercisesOther
Active mobility exercises (jaw opening 6 times of 30 s; lateralization 10 times of 5 s; protrusion 10 times Of 5 s). Self-massage masticatory Muscles, After each session.
- Isometric contraction exercises Were included (3 times of 10 s)
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | VR and traditional Ex Receives: Other: Virtual reality |
| Control group | Experimental | traditional physical therapy ex Receives: Other: Traditional exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure pain
Measure by visual analog scale (VAS) 0: low in pain 10:high in pain
Measured: 6weeks
Secondary outcomes (1)
Maximum mouth opnening (MMO )
Measure by milemeter
Measured: 6weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start10 Mar 2024
- Primary completion1 Jul 2024
- Study completion10 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DisorderStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nehal mohamed soliman Elbkery, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06537661
- Sponsor's protocol ID
- P.T.REC/012/005153
- Status last verified
- Aug 2024
- First submitted
- 2 Jul 2024
- Last updated
- 5 Aug 2024
- 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 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VIRTUAL REALITY and TEMPOROMANDIBULAR DISORDER FOLLOWING MAXILLOFACIAL SURGERY
- ClinicalTrials.gov ID
- NCT06537661
- Acronym / sponsor ID
- P.T.REC/012/005153
- Conditions
- Temporomandibular Disorder
- Keywords
- VR, TMD, Maxillofacial surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Mar 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 10 Sep 2024 (estimated)
- First posted
- 5 Aug 2024 (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.
Sixty eight patients who have TMJ pain and ROM restriction after maxillofacial surgery participated in this study , they are selected from government hospitals (general and insurance ).
Will be randomly divided into two equal groups ( group A, group B ). Their ages range from 20 - 35 years.
The Purpose of the study is to evaluate the therapeutic efficacy of VR in decreasing pain and improve ROM for Patients after maxillofacial surgery.
Detailed description
Sixty eight patients who have TMJ pain and ROM restriction after maxillofacial surgery participated in this study , they are selected from government hospitals (general and insurance ).
Will be randomly divided into two equal groups ( group A, group B ). Their ages range from 20 - 35 years.
The VR glasses which were the source of visual and auditory feedback, were connected by Bluetooth to a mobile phone and all the videos of selected tasks (tasks of Active mobility exercises and isometric contraction exercises, massage exercises) were turned on. Active mobility exercises (jaw opening 6 times of 30 s; lateralization 10 times of 5 s; protrusion 10 times Of 5 s).
- Self-massage masticatory Muscles, After each session.
- Isometric contraction exercises The Purpose of the study is to evaluate the therapeutic efficacy of VR in decreasing pain and improve ROM for Patients after maxillofacial surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: Virtual realityVR and traditional Ex |
| Control group | Experimental | Other: Traditional exercisestraditional physical therapy ex |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- The subject selection will be according to the following criteria:
- • Surgery That conducted on the temporomandibular joint (meniscectomy, arthroscopy, etc.).
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Virtual realityVirtual reality (VR): is the artificial construction of a 3D environment viaThe VR glasses which were the source of visual and auditory feedback, were connected by Bluetooth to a mobile phone and all the videos of selected tasks. | Other | Study group |
| Traditional exercisesActive mobility exercises (jaw opening 6 times of 30 s; lateralization 10 times of 5 s; protrusion 10 times Of 5 s). Self-massage masticatory Muscles, After each session. * Isometric contraction exercises Were included (3 times of 10 s) | Other | Control group |
Primary outcome
Measure pain
Time frame: 6weeks
Measure by visual analog scale (VAS) 0: low in pain 10:high in pain
1 secondary outcome
Maximum mouth opnening (MMO )
Time frame: 6weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Temporomandibular Disorder
Recruiting
Photobiomodulation for Management of Temporomandibular Disorder Pain
Pain Related to TMD
Recruiting
Effects of Vagus Nerve Stimulation on Temporomandibular Disorders.
TMD, Temporomandibular Disorders (TMDs)
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Not yet recruiting
Comparing Dextrose Prolotherapy vs. Sodium Hyaluronic Acid Injections for Jaw Joint Internal Derangement
Temporomandibular Joint Internal Derangement, TMJ-ID
Recruiting
R01_Pilot Jaw Muscle Phenotypes
Chronic TMD Pain, Temporomandibular Disorder
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 Virtual reality and Traditional exercises in people with Temporomandibular Disorder, 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 7 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 5 Aug 2024. 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?
Results are not available in the source record.
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?
Measure pain (time frame: 6weeks). 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 5 Aug 2024.