Application of the Visualization of Treatment Objective (VTO) Analyses in Fabricating Anterior Repositioning Splints

Not Applicable

• Conditions: Temporomandibular Joint Disorders
• Interventions: Procedure: therapeutic position of the anterior repositioning splints

• Registration Number: NCT05362201
• Lead Sponsor: Fujian Medical University

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.

Study Timeline

• Status Verified: 2022-04
• Study Start: 2022-04-01
• Study First Submitted: 2022-04-15
• Study First Submitted QC: 2022-05-04
• Last Update Submitted: 2022-05-04
• Study First Posted: 2022-05-05
• Last Update Posted: 2022-05-05
• Primary Completion: 2022-09-30
• Study Completion: 2022-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the therapeutic position of the ARS were determinded by the VTO analyse	therapeutic position of the anterior repositioning splints	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.
the therapeutic position of the ARS were determinded by the "minimum protrusive position"	therapeutic position of the anterior repositioning splints	the therapeutic position of the ARS were determinded by the "minimum protrusive position",which was the traditional method to fabricate the anterior repositioning splints,the patients were instructed to protrusive the mandible in a therapeutic position in which the click is eliminated.

Primary Outcome Measures

Name	Time	Method
temporomandibular joint function	up to three months	the Craniomandibular Index (CMI) was used to assess the temporomandibular joint function after the inserted of the splints.

Secondary Outcome Measures

Name	Time	Method
psychological assessment the PHQ-9	three months	the PHQ-9 were used to assess the psychological factors in the baseline,1 month,2 and 3 months after the inserted of the splints.
psychological assessment GAD-7	three months	GAD-7 were used to assess the psychological factors in the baseline,1 month,2 and 3 months after the inserted of the splints.
disc-condyle angle	three months	the disc-condyle angle were measured through MRI scan
temporomandibular joint space	three months	the temporomandibular joint space were calculated through CBCT scan

Trial Locations

Locations (1)

Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China