search
Back to results

Comparison of the Centric Relation Recorded by Two Methods Using Cone Beam Computed Tomography

Primary Purpose

Tooth Loss

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
the centric relation
Sponsored by
Fujian Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Loss focused on measuring Cone-Beam computed tomography, the centric relation, the upper airway, mandibular position

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Fujian Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

record the centric relation using the gothic tracing method

record the centric relation using the neuromuscular method

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

the temporomandibular joint space
according to the method of Ikeda and Kawamura, tmj space measurement in sagittal of the CBCT images were performed

Secondary Outcome Measures

the upper airway
Using the sinus/airway feature of the Dolphin software to reconstruct the upper airway,it included three region: the nasopharynx, oropharynx, and hypopharynx

Full Information

First Posted
August 22, 2022
Last Updated
August 22, 2022
Sponsor
Fujian Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT05512442
Brief Title
Comparison of the Centric Relation Recorded by Two Methods Using Cone Beam Computed Tomography
Official Title
Comparison of the Centric Relation Recorded by the Gothic Arch Methods and the Neuromuscular Method Using Cone Beam Computed Tomography
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
April 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fujian Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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)
Detailed Description
ten asymptomatic participants were selected,the centric relation registrations were separately recorded according to the technique of the gothic arch method and the neuromuscular method,subsequent, they were instructed to perform CBCT wearing two bite registrations,thus using dophin software to calculate the tmj space and the upper airway and using exocad software to ananyse the mandibular position, Data were analysed with paired t-test

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Loss
Keywords
Cone-Beam computed tomography, the centric relation, the upper airway, mandibular position

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
record the centric relation using the gothic tracing method
Arm Type
Experimental
Arm Description
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.
Arm Title
record the centric relation using the neuromuscular method
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
the centric relation
Intervention Description
All participants were recorded the centric relation registrations according to the technique of the gothic tracing method and the neuromuscular method separately.
Primary Outcome Measure Information:
Title
the temporomandibular joint space
Description
according to the method of Ikeda and Kawamura, tmj space measurement in sagittal of the CBCT images were performed
Time Frame
immediately
Secondary Outcome Measure Information:
Title
the upper airway
Description
Using the sinus/airway feature of the Dolphin software to reconstruct the upper airway,it included three region: the nasopharynx, oropharynx, and hypopharynx
Time Frame
immediately
Other Pre-specified Outcome Measures:
Title
the mandibular position
Description
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.
Time Frame
immediately

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hao Yu
Organizational Affiliation
Fujian Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fujian Medical University
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350004
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison of the Centric Relation Recorded by Two Methods Using Cone Beam Computed Tomography

We'll reach out to this number within 24 hrs