- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06537661
Effect of Virtual Reality on TMD Following Maxillofacial Surgery
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Giza, Egypt, 20
- Nehal mohamed
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Giza, Egypt
- Nehal mohamed
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Study group
VR and traditional Ex
|
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.
|
|
Experimental: Control group
traditional physical therapy ex
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measure pain
Time Frame: 6weeks
|
Measure by visual analog scale (VAS) 0: low in pain 10:high in pain
|
6weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximum mouth opnening (MMO )
Time Frame: 6weeks
|
Measure by milemeter
|
6weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/005153
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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