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

NCT ID: NCT05362201

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2024-10-30

Brief Summary

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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

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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.

Conditions

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Temporomandibular Joint Disorders

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

therapeutic position of the anterior repositioning splints

Intervention Type 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 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.

Group Type EXPERIMENTAL

therapeutic position of the anterior repositioning splints

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fujian Medical University

OTHER

Sponsor Role lead

Responsible Party

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Hao Yu

Fujian Medical University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hao Yu

Role: PRINCIPAL_INVESTIGATOR

Fujian Medical University

Locations

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Fujian Medical University

Fuzhou, Fujian, China

Site Status

Countries

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China

Other Identifiers

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20220309

Identifier Type: -

Identifier Source: org_study_id