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

Status

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Recruiting

Conditions

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Study Type

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Observational

Enrollment (Anticipated)

Enrollment

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24

Contacts and Locations

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Study Contact

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Study Contact Backup

Study Locations

  • Taiwan
    • Zhongzheng District
      • Taipei City, Zhongzheng District, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

Participation Criteria

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Eligibility Criteria

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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

  1. healthy subject of dental patient at NTUH
  2. 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

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How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

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Sponsor

Sponsor

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National Taiwan University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: TongMei Wang, PHD, School of Dentistry, National Taiwan University College of Medicine.

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

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November 1, 2020

Primary Completion (Anticipated)

Primary Completion

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May 19, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2023

Study Registration Dates

First Submitted

First Submitted

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December 27, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 27, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 30, 2020

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 22, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202008002RINA

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