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

NCT05362201 | Completed DMC

• 1 other identifier: 20220309
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Joint Disorders

Keywords

temporomandibular Joint Anterior Disc Displacement; the visualization of treatment objective (VTO); anterior repositioning Splint

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• psychological assessment the PHQ-9

  three months

• psychological assessment GAD-7

  three months

• disc-condyle angle

  three months

• temporomandibular joint space

  three months

Study Arms (2)

the therapeutic position of the ARS were determinded by the "minimum protrusive position"

ACTIVE COMPARATOR

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 therapeutic position of the ARS were determinded by the VTO analyse

EXPERIMENTAL

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

Interventions

therapeutic position of the anterior repositioning splints PROCEDURE

the ADDWR paricipants will be allocated into 2 grounps and treated with anterior repositioning splints determined by traditional and digitial method respectively.

the therapeutic position of the ARS were determinded by the "minimum protrusive position"; the therapeutic position of the ARS were determinded by the VTO analyse

Eligibility Criteria

• Age: 10 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• pregnant women
• heart pace disorders and epilepsy

Sponsors & Collaborators

• Fujian Medical University: lead

Study Sites (1)

Fujian Medical University

Fuzhou, Fujian, 350004, China

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Study Officials

• Hao Yu

  Fujian Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fujian Medical University

Model Details: 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";group2(digitial group): the therapeutic position of the ARS were determinded by the VTO analyse.

Study Record Dates

• First Submitted: April 15, 2022
• First Posted: May 5, 2022
• Study Start: April 1, 2022
• Primary Completion: September 30, 2023
• Study Completion: October 30, 2024
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)