Tooth LossNCT05512442
Comparison of the Centric Relation Recorded by Two Methods Using Cone Beam Computed Tomography
A study testing the centric relation in people with Tooth Loss, run by Fujian Medical University at 1 site in China.
Trial 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) Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Loss
- What is being tested?
- the centric relation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 1 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Cardiac pacemaker carriers and pregnant women; people with heart pace disorders and epilepsy; Temporomandibular or craniocervical disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Centric Relation Recorded by the Gothic Arch Methods and the Neuromuscular Method Using Cone Beam Computed Tomography
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)
Read the 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
- Conditions
- Tooth Loss
- Being tested
- the centric relation
- Keywords
- Cone-Beam computed tomography, the centric relation, the upper airway, mandibular position
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the centric relationProcedure or surgery
All participants were recorded the centric relation registrations according to the technique of the gothic tracing method and the neuromuscular method separately.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: the centric relation |
What is being measured
The primary outcome is the main question the study is designed to answer.
the temporomandibular joint space
according to the method of Ikeda and Kawamura, tmj space measurement in sagittal of the CBCT images were performed
Measured: immediately
Secondary outcomes (1)
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
Measured: immediately
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start1 Jan 2020
- Primary completion1 Mar 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hao Yu, Fujian Medical University
- Investigators
- Hao Yu, Principal investigator, Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05512442
- Sponsor's protocol ID
- 20200901
- Status last verified
- Aug 2022
- First submitted
- 22 Aug 2022
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Centric Relation Recorded by the Gothic Arch Methods and the Neuromuscular Method Using Cone Beam Computed Tomography
- ClinicalTrials.gov ID
- NCT05512442
- Acronym / sponsor ID
- 20200901
- Conditions
- Tooth Loss
- Keywords
- Cone-Beam computed tomography, the centric relation, the upper airway, mandibular position
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 23 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| record the centric relation using the gothic tracing method | Experimental | Procedure: the centric relationthe 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 | Experimental | Procedure: the centric relationthe 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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Cardiac pacemaker carriers and pregnant women; people with heart pace disorders and epilepsy; Temporomandibular or craniocervical disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the centric relationAll participants were recorded the centric relation registrations according to the technique of the gothic tracing method and the neuromuscular method separately. | Procedure or surgery | record the centric relation using the gothic tracing method, record the centric relation using the neuromuscular method |
Primary outcome
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
1 secondary outcome
the upper airway
Time frame: immediately
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hao Yu principal investigator
Fujian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the centric relation in people with Tooth Loss, run by Fujian Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the temporomandibular joint space (time frame: immediately). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2022.