Plaque detection using intraoral scanning

Plain English Summary

Background and study aims
Plaque is microbial biofilms on surfaces such as teeth that can cause local inflammatory reactions and on a long-term, can lead to oral diseases. In routine clinical practice, dental professionals typically detect plaque by visual examination aided by a dental explorer. Plaque is generally colorless, and can be visualized by staining with a disclosing agent. DAs are special dyes that adhere to the biofilm and contrasts the plaque with color to the white tooth surface. When clinically assessing plaque, the assessment can be supported by using an index - many of these are, however, used more for research than in routine clinical practice.
The general routine clinical procedure for plaque detection has disadvantages such as lack of recording of clinical findings in images and dependency of examiner's skills.
Development of non-invasive techniques independent of human error to assist in plaque detection would have great benefit.
This study is about comparing current standard practice with plaque detection on different modality (3D scans).

Who can participate?
Any adult (over 18 years) can participate, as the study is involving a broad section of the population.

What does the study involve?
The patient will be checked to see if they meet the necessary conditions to be part of the study. They might have different amounts of plaque on their teeth. The dentist will then use special 3D scanning equipment, which is approved for dental use, to take detailed images of the inside of the patient's mouth. After that, the dentist will measure the amount of plaque using a standard method called the Silness & Löe index, which involves looking at the teeth and gums.

Next, the dentist will apply a special dye to the patient's teeth that makes the plaque visible by coloring it. The dentist will take another 3D scan of the teeth with the colored plaque and again measure the plaque using the Silness & Löe index.

In addition to examining the patient's teeth directly, the dentist will also measure the plaque by looking at the 3D scan images. One week later, the dentist will reassess the plaque using the same 3D scan images. Another dentist, who does not know the results of the previous examinations, will also evaluate the plaque on the 3D scan images.

What are the possible benefits and risks of participating?
The benefits of participating are that participants may discover a condition in their mouth they were otherwise unaware of. They will also potentially obtain a better understanding of the importance of good oral hygiene. The risks are that a small number of persons feel the scanner can be uncomfortable if it gets warm. There is also a very small risk that a participant is allergic to the disclosing agent without knowing in advance.

Where is the study run from?
Dental School at University of Bristol (UK)

When is the study starting and how long is it expected to run for?
January 2024 to March 2025

Who is funding the study?
The Danish medical device company, 3Shape

Who is the main contact?
Professor Nicola West, N.X.West@bristol.ac.uk

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• England
• United Kingdom

Study participating centre

Sponsor information

3Shape (Denmark)
Industry

Holmens Kanal 7
Copenhagen
1060
Denmark

Phone	+45 30952141
Email	josefine.jensen@3shape.com
Website	https://www.3shape.com/
"ROR"	https://ror.org/042cmjn68

Funders

Funder type

Industry

Results and Publications

Editorial Notes

12/11/2024: The following changes were made to the trial record:
1. The secondary outcome measures were added.
2. The recruitment end date was changed from 03/01/2025 to 11/11/2024.
19/06/2024: Trial's existence confirmed by Yorkshhire & The Humber - Bradford Leeds Research Ethics Committee.