- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05512442
Comparison of the Centric Relation Recorded by Two Methods Using Cone Beam Computed Tomography
Comparison of the Centric Relation Recorded by the Gothic Arch Methods and the Neuromuscular Method Using Cone Beam Computed Tomography
Study Overview
Detailed Description
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
Genders Eligible for Study
Description
Inclusion Criteria:
absence of the mandibular position Classified as ASA 1 or 2 (normal healthy patient or with mild systemic disease, according to the American Society of Anaesthesiologists Physical Status Classification System); Absence of the symptoms and signs of the temporomandibular joint; Willing to participate and to sign a written informed consent form.
Exclusion Criteria:
Cardiac pacemaker carriers and pregnant women; people with heart pace disorders and epilepsy; Temporomandibular or craniocervical disorders.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: record the centric relation using the gothic tracing method
the vertical dimension of occlusion (VDO) were were determineded through facial appearance observation,thus,the patients were trained to execute bordering protrusive, retrusive and bilateral lateral-protrusive movements wearing the intraoral apparatus and a Gothic Arch Tracing was made, the apex of the Gothic Arch Tracing was defined as the gothic arch position.
|
All participants were recorded the centric relation registrations according to the technique of the gothic tracing method and the neuromuscular method separately.
|
Experimental: record the centric relation using the neuromuscular method
the participant were subjected to a low-frequency transcutaneous electrical nerve stimulation (TENS) using the J5 Myotronics for 45 minutes,With the help of TENS, complete relaxation of the muscles were achieved and the mandibular musculature was induced to guide the mandible in the physiologic position,thus using K7 to track the physical mandibular positon which was defined as the neuromuscular position.
|
All participants were recorded the centric relation registrations according to the technique of the gothic tracing method and the neuromuscular method separately.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the temporomandibular joint space
Time Frame: immediately
|
according to the method of Ikeda and Kawamura, tmj space measurement in sagittal of the CBCT images were performed
|
immediately
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the upper airway
Time Frame: immediately
|
Using the sinus/airway feature of the Dolphin software to reconstruct the upper airway,it included three region: the nasopharynx, oropharynx, and hypopharynx
|
immediately
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the mandibular position
Time Frame: immediately
|
convert the DICOM files into the exocad software and analyse the difference of the mandibular position determined by the technique of the gothic tracing method and the neuromuscular method separately.
|
immediately
|
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20200901
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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