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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04839458
Other study ID # 202102052RINA
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 4, 2021
Est. completion date June 15, 2021

Study information

Verified date June 2022
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date June 15, 2021
Est. primary completion date June 15, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 40 Years
Eligibility 1. Inclusive criteria: - full dentition except third molar - healthy periodontal condition - can sign consent 2. Exclusive criteria: - history of temporomandibular disorders

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Taiwan National Taiwan University Hospital Taipei City Zhongzheng District

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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