Automated Quantification of Dental Plaque

NCT06789835 | Completed DMC

• 1 other identifier: 109/2023
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Plaque

Outcome Measures

Primary Outcomes (1)

• Planimetric plaque index

  Plaque area coverage of teeth

  1 day

Secondary Outcomes (1)

• Turesky modification of the Quigley and Hein Plaque Index

  1 day

Study Arms (1)

Fluorescence imaging of disclosed and undisclosed plaque

Device: Fluorescence imaging of disclosed and undisclosed plaque

Interventions

Fluorescence imaging of disclosed and undisclosed plaque DEVICE

Teeth are imaged using a fluorescence camera/an intraoral scanner before and after plaque disclosure.

Fluorescence imaging of disclosed and undisclosed plaque

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Aarhus: lead
• 3Shape A/S: collaborator
• National and Kapodistrian University of Athens: collaborator

Study Sites (1)

Department of Dentistry and Oral Health, Aarhus University

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Dental Plaque

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Sebastian Schlafer, DDS

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: January 23, 2025
• Study Start: November 17, 2023
• Primary Completion: January 30, 2024
• Study Completion: January 30, 2024
• Last Updated: January 23, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)