- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04690361
Monitoring the EMG Activity and Investigating the Relation Between Occlusal Contact Areas and Occlusal Loads During Light or Heavy Occlusal Forces
February 20, 2023 updated by: National Taiwan University Hospital
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 Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Anticipated)
24
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: TongMei Wang
- Phone Number: 66864 +886-2-23123456
- Email: tongmeiwang@ntu.edu.tw
Study Contact Backup
- Name: ChenPing Lin
- Phone Number: 66864 +886-2-23123456
- Email: b99402005@ntu.edu.tw
Study Locations
-
-
Zhongzheng District
-
Taipei City, Zhongzheng District, Taiwan, 100
- Recruiting
- National Taiwan University Hospital
-
Contact:
- TongMei Wang, PHD
- Phone Number: 66864 +886-2-23123456
- Email: tongmeiwang@ntu.edu.tw
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
- healthy subject of dental patient at NTUH
- dental students
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The relation between occlusal force and EMG data
Time Frame: immediately after the intervention
|
immediately after the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: TongMei Wang, PHD, School of Dentistry, National Taiwan University College of Medicine.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2020
Primary Completion (Anticipated)
May 19, 2023
Study Completion (Anticipated)
July 31, 2023
Study Registration Dates
First Submitted
December 27, 2020
First Submitted That Met QC Criteria
December 27, 2020
First Posted (Actual)
December 30, 2020
Study Record Updates
Last Update Posted (Estimate)
February 22, 2023
Last Update Submitted That Met QC Criteria
February 20, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 202008002RINA
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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