Bite ForceNCT04839458
Investigation of the Effect of Scan Delay on the Measurement of Dental Prescale II
A study testing Dental Prescale II in people with Bite Force and Scan Delay, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Bite Force, Scan Delay
- What is being tested?
- Dental Prescale II
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 May 2021to 15 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
- Inclusive criteria:
- full dentition except third molar
- healthy periodontal condition
- can sign consent
- Exclusive criteria:
- history of temporomandibular disorders
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital
Taipei, Zhongzheng District, 100
About this study
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.
- Conditions
- Bite Force, Scan Delay
- Being tested
- Dental Prescale II
- Keywords
- Dental Prescale II,Scan Delay
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Dental Prescale II used | Experimental | Not described Receives: Device: Dental Prescale II |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start4 May 2021
- Primary completion15 Jun 2021
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bite ForceStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- TongMei Wang Wang, PHD, Principal investigator, School of Dentistry, National Taiwan University College of Medicine.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04839458
- Sponsor's protocol ID
- 202102052RINA
- Status last verified
- Jun 2022
- First submitted
- 5 Apr 2021
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Scan Delay on the Measurement of Dental Prescale II
- ClinicalTrials.gov ID
- NCT04839458
- Acronym / sponsor ID
- 202102052RINA
- Conditions
- Bite Force, Scan Delay
- Keywords
- Dental Prescale II,Scan Delay
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 4 May 2021 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 9 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dental Prescale II used | Experimental | Device: Dental Prescale II |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dental Prescale IIThe 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. | Device | Dental Prescale II used |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
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Postoperative Bite Force After Bioflx and Zirconia Crowns in Children
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TongMei Wang Wang, PHD principal investigator
School of Dentistry, National Taiwan University College of Medicine.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental Prescale II in people with Bite Force and Scan Delay, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The relation between occlusal force and scanning time (time frame: immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2023.