Investigation of the Effect of Scan Delay on the Measurement of Dental Prescale II

April 17, 2023 updated by: National Taiwan University Hospital
Dental Prescale II (GC Corp., Tokyo) is a pressure sensitive sheet for occlusal force measurement. According to the instruction, the patient need to bite the sheet for about 3 seconds and then the sheet will be scanned. But the delay response of coloring agent will influence the data collected and was noticed in vitro. To have a standard procedure, we need to know the time for scanning. This study will scan the sheet up to 2 hours and try to find the relation between the time the sheet scanned and the data collected.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

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

Study Contact Backup

Study Locations

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

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

18 years to 38 years (Adult)

Accepts Healthy Volunteers

Yes

Description

  1. Inclusive criteria:

    • full dentition except third molar
    • healthy periodontal condition
    • can sign consent

  2. 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

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dental Prescale II used
Device: Dental Prescale II
The participant will bite Dental Prescale II for about 3 seconds, using a force for " chewing beef ". And the Dental Prescale II will be taken out from the mouth. Then the trial is end.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The relation between occlusal force and scanning time
Time Frame: immediately after the intervention
After Dental Prescale II is used and cleaned, the first time of scanning will be defined as 0 min. The pressure sensitive sheet will be scanned every minute during 0~15 minutes, and at 30, 60, 90 and 120 minutes.
immediately after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: TongMei Wang 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)

May 4, 2021

Primary Completion (Actual)

June 15, 2021

Study Completion (Actual)

June 15, 2021

Study Registration Dates

First Submitted

April 5, 2021

First Submitted That Met QC Criteria

April 7, 2021

First Posted (Actual)

April 9, 2021

Study Record Updates

Last Update Posted (Actual)

April 19, 2023

Last Update Submitted That Met QC Criteria

April 17, 2023

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 202102052RINA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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