Dental PlaqueNCT06789835
Automated Quantification of Dental Plaque
An observational study of Dental Plaque, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque
- What is being tested?
- Fluorescence imaging of disclosed and undisclosed plaque
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 17 Nov 2023to 30 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults
Who may be able to join
- 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
Who cannot join
- History of allergies towards any of the ingredients in the disclosing agents Self-reported serious medical conditions
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Dentistry and Oral Health, Aarhus University
Aarhus, 8000
About this study
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
- Being tested
- Fluorescence imaging of disclosed and undisclosed plaque
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorescence imaging of disclosed and undisclosed plaqueDevice
Teeth are imaged using a fluorescence camera/an intraoral scanner before and after plaque disclosure.
| Study group | Role | What they receive |
|---|---|---|
| Fluorescence imaging of disclosed and undisclosed plaque | Not described Receives: Device: Fluorescence imaging of disclosed and undisclosed plaque |
What is being measured
The primary outcome is the main question the study is designed to answer.
Planimetric plaque index
Plaque area coverage of teeth
Measured: 1 day
Secondary outcomes (1)
Turesky modification of the Quigley and Hein Plaque Index
Plaque coverage of teeth
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start17 Nov 2023
- Primary completion30 Jan 2024
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental PlaqueStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- 3Shape A/S, National and Kapodistrian University of Athens
- Responsible party
- Sponsor
- Investigators
- Sebastian Schlafer, DDS, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06789835
- Sponsor's protocol ID
- 109/2023
- Status last verified
- Dec 2024
- First submitted
- 19 Dec 2024
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Quantification of Dental Plaque
- ClinicalTrials.gov ID
- NCT06789835
- Acronym / sponsor ID
- 109/2023
- Conditions
- Dental Plaque
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- 3Shape A/S, National and Kapodistrian University of Athens
- Study start
- 17 Nov 2023 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 23 Jan 2025 (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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluorescence imaging of disclosed and undisclosed plaque | – | Device: Fluorescence imaging of disclosed and undisclosed plaque |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- History of allergies towards any of the ingredients in the disclosing agents Self-reported serious medical conditions
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 |
|---|---|---|
| Fluorescence imaging of disclosed and undisclosed plaqueTeeth are imaged using a fluorescence camera/an intraoral scanner before and after plaque disclosure. | Device | Fluorescence imaging of disclosed and undisclosed plaque |
Primary outcome
Planimetric plaque index
Time frame: 1 day
Plaque area coverage of teeth
1 secondary outcome
Turesky modification of the Quigley and Hein Plaque Index
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Individual participant dataSharing planned: No. 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.
Related trials for Dental Plaque
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
Not yet recruitingObservational study
Plaque and Bleeding on Probing Around Implants Supporting Fixed Full-Arch Dental Prostheses
Peri-Implant Health
Not yet recruiting
Effectiveness of Oil Pulling Using Oils in Comparison With Mouthwash for Gingivitis
Gingivitis
Not yet recruiting
Individualized Management of Plaque-Related Gingival Inflammation in Routine Dental Practice
Plaque-Induced Gingivitis
Recruiting
The Study to Evaluate the Plaque Control and Anti-Gingivitis Efficacy of a Toothpaste in Chinese Population
Dental Plaque, Gingivitis
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. This study is not recruiting at the moment.
Sebastian Schlafer, DDS principal investigator
University of Aarhus
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 Dental Plaque, run by University of Aarhus at 1 site in Denmark.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 23 Jan 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Planimetric plaque index (time frame: 1 day). 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 23 Jan 2025.