Plaque, DentalNCT06511830
Effectiveness of Plaque Score Detection Techniques
An observational study of Plaque, Dental, run by University of Nebraska at 1 site in United States.
Trial summary
This study investigates the similarity between microbial plaque scores when assessing the entire dentition versus select teeth. The hypothesis posits that plaque buildup on single teeth mirrors that of the entire mouth, facilitating efficient plaque data collection and generalized deductions. Read more about this study
- Who is it for?
- Ages 19 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Plaque, Dental
- What is being tested?
- Dental Monitoring images
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2024to Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 19 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be routine patients at the UNMC College of Dentistry clinics.
Who may be able to join
- 19-85 years old
- Patient at the University of Nebraska Medical Center (UNMC) College of Dentistry
- One molar, premolar or canine pe quadrant
Who cannot join
- No permanent dental devices (braces, splints)
- Less than 20 non-restored teeth present in the dentition
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Nebraska Medical Center Dental College
Lincoln, Nebraska, 68583-0740
James Wahl, PhD, 402-472-1324, jwahl@unmc.edu
About this study
Official title: The Effectiveness of Detecting Plaque on Tooth Surfaces Using Traditional and Artificial Intelligence Monitoring
This study investigates the similarity between microbial plaque scores when assessing the entire dentition versus select teeth. The hypothesis posits that plaque buildup on single teeth mirrors that of the entire mouth, facilitating efficient plaque data collection and generalized deductions. Additionally, the research explores the potential of Dental Monitoring© photos in accurately identifying plaque indexes, aiming to enhance plaque evaluation efficiency in dental appointments. The null hypothesis suggests no significant difference between full dentition plaque scores and selected teeth. Results may streamline plaque tracking in patient appointments and enable remote monitoring, potentially detecting plaque accumulation issues earlier.
Read the detailed description
Following the obtainment of participant consent, data will be collected during participant's routine prophylaxis appointment or during designated clinic time open for participants to volunteer. Utilizing a scan box provided by Dental Monitoring©, a scan (series of intra-oral images) will be taken of the participant's dentition. The scan will be taken once before disclosing solution (erythrosine) is introduced to the dentition and once after.
The disclosing solution will allow for visualization of plaque. The presence of plaque on all teeth surfaces will be recorded using the O'Leary Plaque Index. No procedures (other than the intra-oral photos), interventions, evaluations or tests will be performed more frequently than they would be if the participant was not participating in the research. The only participant demographic information that will be recorded for this study is age.
Participants who opt to come in voluntarily for only data collection will not receive a prophylaxis. Their plaque information will be collected, and they will be dismissed.
Oversight procedures in place: The Scan Boxes will be utilized by the investigators to take intra-oral photographs of each patient's dentition. These will be sterilized between each participant and stored in the College of Dentistry's clinic lockers when not in use.
- Conditions
- Plaque, Dental
- Being tested
- Dental Monitoring images
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental Monitoring imagesDiagnostic test
Dental Monitoring is a series of intraoral photos that will be taken and assessed to determine the subject's dental plaque levels.
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Visibly Detectable Plaque
The presence of dental plaque will be determined by visual presence or absence of dental plaque at 6 sites per tooth. The presence of dental plaque is reported as a percentage of tooth surfaces with visibly detectable plaque.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start20 Nov 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque, DentalStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy Killeen, DDS, MS, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06511830
- Sponsor's protocol ID
- 0341-24-FB
- Status last verified
- Jun 2025
- First submitted
- 15 Jul 2024
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Detecting Plaque on Tooth Surfaces Using Traditional and Artificial Intelligence Monitoring
- ClinicalTrials.gov ID
- NCT06511830
- Acronym / sponsor ID
- 0341-24-FB
- Conditions
- Plaque, Dental
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 22 Jul 2024 (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.
This study investigates the similarity between microbial plaque scores when assessing the entire dentition versus select teeth. The hypothesis posits that plaque buildup on single teeth mirrors that of the entire mouth, facilitating efficient plaque data collection and generalized deductions. Additionally, the research explores the potential of Dental Monitoring© photos in accurately identifying plaque indexes, aiming to enhance plaque evaluation efficiency in dental appointments. The null hypothesis suggests no significant difference between full dentition plaque scores and selected teeth. Results may streamline plaque tracking in patient appointments and enable remote monitoring, potentially detecting plaque accumulation issues earlier.
Detailed description
Following the obtainment of participant consent, data will be collected during participant's routine prophylaxis appointment or during designated clinic time open for participants to volunteer. Utilizing a scan box provided by Dental Monitoring©, a scan (series of intra-oral images) will be taken of the participant's dentition. The scan will be taken once before disclosing solution (erythrosine) is introduced to the dentition and once after.
The disclosing solution will allow for visualization of plaque. The presence of plaque on all teeth surfaces will be recorded using the O'Leary Plaque Index. No procedures (other than the intra-oral photos), interventions, evaluations or tests will be performed more frequently than they would be if the participant was not participating in the research. The only participant demographic information that will be recorded for this study is age.
Participants who opt to come in voluntarily for only data collection will not receive a prophylaxis. Their plaque information will be collected, and they will be dismissed.
Oversight procedures in place: The Scan Boxes will be utilized by the investigators to take intra-oral photographs of each patient's dentition. These will be sterilized between each participant and stored in the College of Dentistry's clinic lockers when not in use.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be routine patients at the UNMC College of Dentistry clinics.
Key inclusion criteria (3 listed)
- 19-85 years old
- Patient at the University of Nebraska Medical Center (UNMC) College of Dentistry
- One molar, premolar or canine pe quadrant
Key exclusion criteria (2 listed)
- No permanent dental devices (braces, splints)
- Less than 20 non-restored teeth present in the dentition
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 Monitoring imagesDental Monitoring is a series of intraoral photos that will be taken and assessed to determine the subject's dental plaque levels. | Diagnostic test | – |
Primary outcome
Presence of Visibly Detectable Plaque
Time frame: Baseline
The presence of dental plaque will be determined by visual presence or absence of dental plaque at 6 sites per tooth. The presence of dental plaque is reported as a percentage of tooth surfaces with visibly detectable plaque.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Amy Killeen, DDS, MS principal investigator
University of Nebraska
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 Plaque, Dental, run by University of Nebraska 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 3 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: looking for participants now, as of the sponsor's last update on 11 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amy Killeen, DDS, MS (402-472-7848, akilleen@unmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Visibly Detectable Plaque (time frame: Baseline). 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 11 Jun 2025.