Clinical trial NCT05362201: Application of the Visualization of Treatment Objective (VTO) Analyses in Fabricating Anterior Repositioning Splints
Official title: Application of the Visualization of Treatment Objective (VTO) Analyses in the Treatment of the Temporomandibular Joint Disc Displacement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Temporomandibular Joint Disorders
Keywords: temporomandibular Joint Anterior Disc Displacement
the visualization of treatment objective (VTO)
anterior repositioning Splint
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2022-05-05
Enrollment: 20
Sex: ALL
Minimum age (years): 10
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model 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";group2(digitial group): the therapeutic position of the ARS were determinded by the VTO analyse.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: temporomandibular joint function
timeFrame: up to three months
Secondary outcomes:
measure: psychological assessment the PHQ-9
timeFrame: three months
measure: psychological assessment GAD-7
timeFrame: three months
measure: disc-condyle angle
timeFrame: three months
measure: temporomandibular joint space
timeFrame: three months
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University
state: Fujian
Study officials:
affiliation: Fujian Medical University
name: Hao Yu Hao Yu
role: PRINCIPAL_INVESTIGATOR
References: