- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06511830
Effectiveness of Plaque Score Detection Techniques
The Effectiveness of Detecting Plaque on Tooth Surfaces Using Traditional and Artificial Intelligence Monitoring
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Amy Killeen, DDS, MS
- Phone Number: 402-472-7848
- Email: akilleen@unmc.edu
Study Locations
-
-
Nebraska
-
Lincoln, Nebraska, United States, 68583-0740
- Recruiting
- University of Nebraska Medical Center Dental College
-
Contact:
- James Wahl, PhD
- Phone Number: 402-472-1324
- Email: jwahl@unmc.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 19-85 years old
- Patient at the University of Nebraska Medical Center (UNMC) College of Dentistry
- One molar, premolar or canine pe quadrant
Exclusion Criteria:
- No permanent dental devices (braces, splints)
- Less than 20 non-restored teeth present in the dentition
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Amy Killeen, DDS, MS, University of Nebraska
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0341-24-FB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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