Bite Force, EMGNCT04690361
Monitoring the EMG Activity and Investigating the Relation Between Occlusal Contact Areas and Occlusal Loads During Light or Heavy Occlusal Forces
An observational study of Bite Force, EMG, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Inappropriate occlusal contact may affect the long-term prognosis of prosthodontic rehabilitation. It is suggested to design light or without occlusal contact on implant prostheses when the patient bites with light force, and normal occlusal contact when the patient bites with heavy force. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Bite Force, EMG
- How many people
- 24 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2020to 31 Jul 2023
- Phase
- Observational
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 1. healthy subject of dental patient at NTUH 2. dental students
Inclusive criteria:
- full dentition except third molar
- class I occlusion at bilateral canines and first molars (Angle's classification)
- healthy periodontal condition
- can sign consent
Exclusive criteria:
-history of temporomandibular disorders
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Zhongzheng District, 100
TongMei Wang, PHD, +886-2-23123456 ext. 66864, tongmeiwang@ntu.edu.tw
About this study
Inappropriate occlusal contact may affect the long-term prognosis of prosthodontic rehabilitation. It is suggested to design light or without occlusal contact on implant prostheses when the patient bites with light force, and normal occlusal contact when the patient bites with heavy force. The concept of this "implant-protective occlusion" is based on the difference of movement between implants and natural teeth. However, how much force generated during a light bite or a heavy bite is not clearly defined in the literature. Traditional methods to evaluate the occlusal contacts between antagonist teeth such as wax, silicone, occlusal paper, and occlusal foil cannot evaluate the occlusal force. Recently, modern digital occlusion analysis systems (T-Scan, Dental Prescale II) can evaluate occlusal force on almost normal intermaxillary relation. The objects of this investigation are: (1) to evaluate the effect of difference occlusal forces on the number, distribution and size of occlusal contacts examined by 8μm occlusal foil and Dental Prescale II System (DPS); (2) to analyze the relation between EMG activity and occlusal forces and to identify the magnitude of light and heavy bite force the patients may exert during occlusal examination; (3) to compare the results between habitual chewing side and the other side. Twenty-four subjects will be included in this study. With EMG biofeedback, the subjects will exert 35%、70%、100% of maximum contraction EMG of clenching and the subjects' occlusal contacts will be tested with the 8μm occlusal foil and DPS. Each condition will be tested three times. The subjects will chew gums to confirm their habitual chewing side after the occlusal tests. Numbers, distribution, and size of occlusal contacts will be analyzed and compared. This study may identify the magnitude of perceptual light and heavy occlusal forces and the maximum occlusal force. The results are helpful for setting up the protocol and strategy of occlusal adjustment and to prevent biomechanical complications of dental prostheses.
- Conditions
- Bite Force, EMG
- Keywords
- occlusal contact,occlusal force,Electromyography,Dental PreScale System
What is being measured
The primary outcome is the main question the study is designed to answer.
The relation between occlusal force and EMG data
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start1 Nov 2020
- Primary completion19 May 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bite Force, EMGStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- TongMei Wang, PHD, Principal investigator, School of Dentistry, National Taiwan University College of Medicine.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04690361
- Sponsor's protocol ID
- 202008002RINA
- Status last verified
- Feb 2023
- First submitted
- 27 Dec 2020
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring the EMG Activity and Investigating the Relation Between Occlusal Contact Areas and Occlusal Loads During Light or Heavy Occlusal Forces
- ClinicalTrials.gov ID
- NCT04690361
- Acronym / sponsor ID
- 202008002RINA
- Conditions
- Bite Force, EMG
- Keywords
- occlusal contact,occlusal force,Electromyography,Dental PreScale System
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 19 May 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 30 Dec 2020 (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.
Inappropriate occlusal contact may affect the long-term prognosis of prosthodontic rehabilitation. It is suggested to design light or without occlusal contact on implant prostheses when the patient bites with light force, and normal occlusal contact when the patient bites with heavy force. The concept of this "implant-protective occlusion" is based on the difference of movement between implants and natural teeth. However, how much force generated during a light bite or a heavy bite is not clearly defined in the literature. Traditional methods to evaluate the occlusal contacts between antagonist teeth such as wax, silicone, occlusal paper, and occlusal foil cannot evaluate the occlusal force. Recently, modern digital occlusion analysis systems (T-Scan, Dental Prescale II) can evaluate occlusal force on almost normal intermaxillary relation. The objects of this investigation are: (1) to evaluate the effect of difference occlusal forces on the number, distribution and size of occlusal contacts examined by 8μm occlusal foil and Dental Prescale II System (DPS); (2) to analyze the relation between EMG activity and occlusal forces and to identify the magnitude of light and heavy bite force the patients may exert during occlusal examination; (3) to compare the results between habitual chewing side and the other side. Twenty-four subjects will be included in this study. With EMG biofeedback, the subjects will exert 35%、70%、100% of maximum contraction EMG of clenching and the subjects' occlusal contacts will be tested with the 8μm occlusal foil and DPS. Each condition will be tested three times. The subjects will chew gums to confirm their habitual chewing side after the occlusal tests. Numbers, distribution, and size of occlusal contacts will be analyzed and compared. This study may identify the magnitude of perceptual light and heavy occlusal forces and the maximum occlusal force. The results are helpful for setting up the protocol and strategy of occlusal adjustment and to prevent biomechanical complications of dental prostheses.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 1. healthy subject of dental patient at NTUH 2. dental students
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The relation between occlusal force and EMG data
Time frame: immediately after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
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.
TongMei Wang, PHD principal investigator
School of Dentistry, National Taiwan University College of Medicine.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bite Force, EMG, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 22 Feb 2023. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact TongMei Wang (+886-2-23123456 ext. 66864, tongmeiwang@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The relation between occlusal force and EMG data (time frame: immediately after the intervention). 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 22 Feb 2023.