- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07575633
Ultrasound Versus Virtual Reality on Temporomandibular Disorder
Ultrasound Versus Virtual Reality on Temporomandibular Disorder Following Surgical Tooth Extraction
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study will be carried out on patients suffering from temporomandibular joint disorder following tooth extraction surgery. Their ages will range from (40-60) years. They will be randomly divided into two equal groups:
Group A:
This group will include 25 patients suffering from TMJ dysfunction (pain and reduced mouth opening) after tooth extraction. They will receive pulsed ultrasound and traditional manual therapy. The first session of treatment will be 24hr after extraction for three times for one week.
- Group B:
This group will include 25 patients suffering from TMJ dysfunction (pain and reduced mouth opening) after tooth extraction. They will receive virtual reality and traditional manual therapy. The first session of treatment will be 24hr after extraction for three times for one week.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Amany R M Abdel Wahid, Lecturer
- Phone Number: +201018965528
- Email: amany.reffat.ar@cu.edu.eg
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 tooth extraction.
- Patients from both genders.
- Patients suffering from pain and reduced mouth opening.
- Age ranges between 40-60 years.
- All patients will have informed consent.
Exclusion Criteria:
. Surgery that conducted on the temporomandibular joint (meniscectomy, arthroscopy, etc.).
- Patients with systemic disease as diabetes mellitus.
- Patients with neurological conditions.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: group who will receive ultrasound
They will receive pulsed ultrasound and traditional manual therapy.
|
pulsed ultrasound
|
|
Active Comparator: group who will receive virtual reality
they will receive virtual reality and traditional manual therapy.
|
Fully Immersive VR
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pain free maximum mouth opening (MMO)
Time Frame: before and after the treatment (after 1 week)
|
Millimeter ruler for measuring pain free maximum mouth opening (MMO)
|
before and after the treatment (after 1 week)
|
|
pain measurement
Time Frame: before and after the treatment ( 1 week)
|
Visual Analogue Scale for pain measurement (VAS).
|
before and after the treatment ( 1 week)
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.TREC/012/006341
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
product manufactured in and exported from the U.S.
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.
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