NCT04839458

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 9, 2021

Completed
25 days until next milestone

Study Start

First participant enrolled

May 4, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2021

Completed
Last Updated

April 19, 2023

Status Verified

June 1, 2022

Enrollment Period

1 month

First QC Date

April 5, 2021

Last Update Submit

April 17, 2023

Conditions

Bite ForceScan Delay

Keywords

Dental Prescale II,Scan Delay

Outcome Measures

Primary Outcomes (1)

  • The relation between occlusal force and scanning time

    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

Study Arms (1)

Dental Prescale II used

EXPERIMENTAL
Device: Dental Prescale II

Interventions

Dental Prescale IIDEVICE

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.

Dental Prescale II used

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
1. Inclusive criteria: * full dentition except third molar * healthy periodontal condition * can sign consent 2. Exclusive criteria: * history of temporomandibular disorders

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Zhongzheng District, 100, Taiwan

Location

Study Officials

  • TongMei Wang Wang, PHD

    School of Dentistry, National Taiwan University College of Medicine.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2021

First Posted

April 9, 2021

Study Start

May 4, 2021

Primary Completion

June 15, 2021

Study Completion

June 15, 2021

Last Updated

April 19, 2023

Record last verified: 2022-06

Locations

TW(1)