Automated Quantification of Dental Plaque

January 16, 2025 updated by: University of Aarhus
The study generates data that contribute to the development and validation of an automated approach to full-mouth quantification of dental plaque, based on fluorescence images and intraoral scans of teeth with disclosed and undisclosed plaque.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Department of Dentistry and Oral Health, Aarhus University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Adults

Description

Inclusion Criteria:

Males and females ≥ 18 years old Presence of at least one tooth Anatomically possible to perform intraoral imaging Subjects need to be able to understand and follow instructions, as well as to read and sign the informed consent form

Exclusion Criteria:

History of allergies towards any of the ingredients in the disclosing agents Self-reported serious medical conditions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Fluorescence imaging of disclosed and undisclosed plaque
Device: Fluorescence imaging of disclosed and undisclosed plaque
Teeth are imaged using a fluorescence camera/an intraoral scanner before and after plaque disclosure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Planimetric plaque index
Time Frame: 1 day
Plaque area coverage of teeth
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Turesky modification of the Quigley and Hein Plaque Index
Time Frame: 1 day
Plaque coverage of teeth
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

National and Kapodistrian University of Athens
3Shape A/S

Investigators

  • Principal Investigator: Sebastian Schlafer, DDS, University of Aarhus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2023

Primary Completion (Actual)

January 30, 2024

Study Completion (Actual)

January 30, 2024

Study Registration Dates

First Submitted

December 19, 2024

First Submitted That Met QC Criteria

January 16, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 16, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 109/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due to general data protection regulations, individual participant data will not be made available publicly. Summary data will be made available upon publication of the results.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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