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Completed

NCT Number: NCT05362201

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

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.

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Key information

Age range

10 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fujian Medical University

Fuzhou, Fujian, 350004, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. psychological assessment the PHQ-9

    Time frame: 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.

  2. psychological assessment GAD-7

    Time frame: 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.

  3. disc-condyle angle

    Time frame: three months

    the disc-condyle angle were measured through MRI scan

  4. temporomandibular joint space

    Time frame: three months

    the temporomandibular joint space were calculated through CBCT scan

Sponsors and collaborators

Lead sponsor

Fujian Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
May 5, 2022
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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