Comparison of the Centric Relation Recorded by Two Methods Using Cone Beam Computed Tomography
1 other identifier
interventional
10
1 country
1
Brief Summary
The purpose of this study was to investigate and compare the variation in mandibular relation recorded by the gothic arch methods and the K7 method using cone beam computed tomography (CBCT)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2021
CompletedFirst Submitted
Initial submission to the registry
August 22, 2022
CompletedFirst Posted
Study publicly available on registry
August 23, 2022
CompletedAugust 23, 2022
August 1, 2022
1.2 years
August 22, 2022
August 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the temporomandibular joint space
according to the method of Ikeda and Kawamura, tmj space measurement in sagittal of the CBCT images were performed
immediately
Secondary Outcomes (1)
the upper airway
immediately
Other Outcomes (1)
the mandibular position
immediately
Study Arms (2)
record the centric relation using the gothic tracing method
EXPERIMENTALthe 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.
record the centric relation using the neuromuscular method
EXPERIMENTALthe 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.
Interventions
All participants were recorded the centric relation registrations according to the technique of the gothic tracing method and the neuromuscular method separately.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Cardiac pacemaker carriers and pregnant women; people with heart pace disorders and epilepsy; Temporomandibular or craniocervical disorders.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fujian Medical University
Fuzhou, Fujian, 350004, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hao Yu
Fujian Medical University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Fujian Medical University
Study Record Dates
First Submitted
August 22, 2022
First Posted
August 23, 2022
Study Start
January 1, 2020
Primary Completion
March 1, 2021
Study Completion
April 1, 2021
Last Updated
August 23, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share