Other Dental Disease/Condition of Teeth/Supporting StructureNCT02271789
Low-cost, Noninvasive Method to Assess Pulpal Vitality
An observational study of Other Dental Disease/Condition of Teeth/Supporting Structure, run by University of California, Irvine at 1 site in United States.
Trial summary
The purpose of this research study is to find a new way of using light to measure the blood flow within the tooth. The researcher develop dental Laser Speckle imaging system tool that can use for exam condition of the tooth. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Other Dental Disease/Condition of Teeth/Supporting Structure
- What is being tested?
- problematic tooth
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Oct 2018
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study population will be selected from affiliated researcher at Dentists clinic in Orange Country and will be referred to investigator at University of California Irvine
Who may be able to join
- Male or female aged 18 to 30.
- Have one or more teeth requiring endodontic treatment.
Who cannot join
- Participation in other study within 3 months of enrollment in this study,
- Pregnant Women.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beckman Laser Institute, UCI
Irvine, California, 92612
About this study
The purpose of this research study is to find a new way of using light to measure the blood flow within the tooth.
The researcher develop dental Laser Speckle imaging system tool that can use for exam condition of the tooth. This device is reliable method to provide information to dentists and endodontists during oral examination.
Read the detailed description
In additional to routine oral exam the researcher can use the Laser Speckle imaging system probe with low-level light shine to the problematic tooth to collect blood flow information.
- Being tested
- problematic tooth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
problematic toothOther
problematic tooth
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthy tooth
Healthy tooth
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionOct 2018 (estimated)
- Study completionOct 2018 (estimated)
Why it stopped: Not a clinical trial study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Other Dental Disease/Condition of Teeth/Supporting StructureStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine
- Responsible party
- Principal investigator, Beckman Laser Institute and Medical Center, University of California, Irvine
- Investigators
- Petra Wilder-Smith, DDS., PhD, Principal investigator, Beckman Laser Instiute, UCI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02271789
- Sponsor's protocol ID
- 20141390
- Status last verified
- Oct 2022
- First submitted
- 9 Oct 2014
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-cost, Noninvasive Method to Assess Pulpal Vitality
- ClinicalTrials.gov ID
- NCT02271789
- Acronym / sponsor ID
- 20141390
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Not a clinical trial study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine
- Study start
- Nov 2014
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 22 Oct 2014 (estimated)
- 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.
The purpose of this research study is to find a new way of using light to measure the blood flow within the tooth.
The researcher develop dental Laser Speckle imaging system tool that can use for exam condition of the tooth. This device is reliable method to provide information to dentists and endodontists during oral examination.
Detailed description
In additional to routine oral exam the researcher can use the Laser Speckle imaging system probe with low-level light shine to the problematic tooth to collect blood flow information.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study population will be selected from affiliated researcher at Dentists clinic in Orange Country and will be referred to investigator at University of California Irvine
Key inclusion criteria (2 listed)
- Male or female aged 18 to 30.
- Have one or more teeth requiring endodontic treatment.
Key exclusion criteria (2 listed)
- Participation in other study within 3 months of enrollment in this study,
- Pregnant Women.
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 |
|---|---|---|
| problematic toothproblematic tooth | Other | – |
Primary outcome
Healthy tooth
Time frame: up to 4 weeks
Healthy tooth
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
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.
Petra Wilder-Smith, DDS., PhD principal investigator
Beckman Laser Instiute, UCI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Other Dental Disease/Condition of Teeth/Supporting Structure, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. 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: withdrawn, as of the sponsor's last update on 1 Nov 2022. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Healthy tooth (time frame: up to 4 weeks). 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 1 Nov 2022.