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Clinical Trials/NCT05362201
NCT05362201
Completed
N/A

Application of the Visualization of Treatment Objective (VTO) Analyses in the Treatment of the Temporomandibular Joint Disc Displacement

Fujian Medical University1 site in 1 country20 target enrollmentApril 1, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Temporomandibular Joint Disorders
Sponsor
Fujian Medical University
Enrollment
20
Locations
1
Primary Endpoint
temporomandibular joint function
Status
Completed
Last Updated
4 months ago

Overview

Brief Summary

This study conducted a randomized controlled clinical trial to evaluate the effect of the the therapeutic position of the anterior repositioning splint determined by VTO analyse compared with traditional method for the treatment of the Anterior Disk Displacement with Reduction of the Temporomandibular Joint.

Detailed Description

A randomised clinical trial was conducted with 20 patients diagnosed with ADDWR through RDC/TMD and they were randomly allocated into the group 1(traditional group):the therapeutic position of the ARS were determinded by the "minimum protrusive position",which was the traditional method to fabricate the anterior repositioning splints;group2(digitial group): the therapeutic position of the ARS were determinded by the VTO analyse,first,the participants were constructed to take CBCT and MRI scans,the ideal therapeutic position of the ARS were located in which the temporomandibular joint space distribute well and the condylar recapture the disc,the dentist could determine the amount of condylar movement and performed VTO analyse by assessing the CBCT and MRI scans ,then it could easily realize the final condylar movements with the application of the dental articulator. They were followed-up in the baseline,1 month,2 and 3 months after the inserted of the splints using the Craniomandibular Index (CMI) for temporomandibular joint function and PHQ-9,GAD-7 for psychological assessments,the tmj space and disc-condylar angle were measured through the CBCT and MRI scans,before and after ARS therapy.

Registry
clinicaltrials.gov
Start Date
April 1, 2022
End Date
October 30, 2024
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Fujian Medical University
Responsible Party
Principal Investigator
Principal Investigator

Hao Yu

Fujian Medical University

Fujian Medical University

Eligibility Criteria

Inclusion Criteria

  • anterior disc displacement with reduction (ADDWR) confirmed by magnetic resonance imaging (MRI)
  • Classified as ASA 1 or 2
  • Willing to participate and sign a written informed consent form.

Exclusion Criteria

  • pregnant women
  • heart pace disorders and epilepsy

Outcomes

Primary Outcomes

temporomandibular joint function

Time Frame: up to three months

the Craniomandibular Index (CMI) was used to assess the temporomandibular joint function after the inserted of the splints.

Secondary Outcomes

  • psychological assessment the PHQ-9(three months)
  • psychological assessment GAD-7(three months)
  • disc-condyle angle(three months)
  • temporomandibular joint space(three months)

Study Sites (1)

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