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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Fujian
-
Fuzhou, Fujian, China, 350004
- Fujian Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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.
|
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.
|
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
Time Frame: up to three months
|
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
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.
|
three months
|
|
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.
|
three months
|
|
disc-condyle angle
Time Frame: three months
|
the disc-condyle angle were measured through MRI scan
|
three months
|
|
temporomandibular joint space
Time Frame: three months
|
the temporomandibular joint space were calculated through CBCT scan
|
three months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hao Yu, Fujian Medical University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20220309
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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