NCT05512442

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 23, 2022

Completed
Last Updated

August 23, 2022

Status Verified

August 1, 2022

Enrollment Period

1.2 years

First QC Date

August 22, 2022

Last Update Submit

August 22, 2022

Conditions

Keywords

Cone-Beam computed tomographythe centric relationthe upper airwaymandibular position

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

EXPERIMENTAL

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.

Procedure: the centric relation

record the centric relation using the neuromuscular method

EXPERIMENTAL

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.

Procedure: the centric relation

Interventions

All participants were recorded the centric relation registrations according to the technique of the gothic tracing method and the neuromuscular method separately.

record the centric relation using the gothic tracing methodrecord the centric relation using the neuromuscular method

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

MeSH Terms

Conditions

Tooth Loss

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesTooth Diseases

Study Officials

  • Hao Yu

    Fujian Medical University

    PRINCIPAL INVESTIGATOR

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

Locations