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

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

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.

Study Overview

• Status: Completed
• Conditions: Temporomandibular Joint Disorders
• Intervention / Treatment: Procedure: therapeutic position of the anterior repositioning splints

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350004
      • Fujian Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: the therapeutic position of the ARS were determinded by the "minimum protrusive position"; 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.	Procedure: therapeutic position of the anterior repositioning splints; the ADDWR paricipants will be allocated into 2 grounps and treated with anterior repositioning splints determined by traditional and digitial method respectively.
Experimental: the therapeutic position of the ARS were determinded by the VTO analyse; 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.	Procedure: therapeutic position of the anterior repositioning splints; the ADDWR paricipants will be allocated into 2 grounps and treated with anterior repositioning splints determined by traditional and digitial method respectively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
temporomandibular joint function	the Craniomandibular Index (CMI) was used to assess the temporomandibular joint function after the inserted of the splints.	up to three months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fujian Medical University
• Investigators: Principal Investigator: Hao Yu, Fujian Medical University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): October 30, 2024

Study Registration Dates

• First Submitted: April 15, 2022
• First Submitted That Met QC Criteria: May 4, 2022
• First Posted (Actual): May 5, 2022

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: temporomandibular Joint Anterior Disc Displacement; the visualization of treatment objective (VTO); anterior repositioning Splint
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Muscular Diseases; Joint Diseases; Jaw Diseases; Mandibular Diseases; Craniomandibular Disorders; Temporomandibular Joint Disorders
• Other Study ID Numbers: 20220309

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No