NCT06537661

Brief 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. The Purpose of the study is to evaluate the therapeutic efficacy of VR in decreasing pain and improve ROM for Patients after maxillofacial surgery.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 2, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 5, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2024

Completed
Last Updated

August 5, 2024

Status Verified

August 1, 2024

Enrollment Period

4 months

First QC Date

July 2, 2024

Last Update Submit

August 1, 2024

Conditions

Keywords

VRTMDMaxillofacial surgery

Outcome Measures

Primary Outcomes (1)

  • Measure pain

    Measure by visual analog scale (VAS) 0: low in pain 10:high in pain

    6weeks

Secondary Outcomes (1)

  • Maximum mouth opnening (MMO )

    6weeks

Study Arms (2)

Study group

EXPERIMENTAL

VR and traditional Ex

Other: Virtual reality

Control group

EXPERIMENTAL

traditional physical therapy ex

Other: Traditional exercises

Interventions

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.

Study group

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)

Control group

Eligibility Criteria

Age30 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nehal mohamed

Giza, 20, Egypt

Location

Nehal mohamed

Giza, Egypt

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 2, 2024

First Posted

August 5, 2024

Study Start

March 10, 2024

Primary Completion

July 1, 2024

Study Completion

September 10, 2024

Last Updated

August 5, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations