Dental Plaque (Diagnosis)NCT07152314
Digital Quantification of Dental Plaque Based on Intraoral Scanner Images
An observational study of Dental Plaque (Diagnosis) and Dental Plaque Imaging Methods, run by University of Guarulhos at 1 site in Brazil.
Trial summary
This diagnostic validation study aims to develop and validate a digital method for dental biofilm quantification using three-dimensional images obtained by an intraoral scanner. Twenty participants will undergo intraoral scanning at three time points: before and after plaque disclosure, and after supervised… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque (Diagnosis), Dental Plaque Imaging Methods, Dental Plaque
- What is being tested?
- Digital plaque quantification using intraoral scanner
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 19 Sep 2025to 4 Oct 2025
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Recruitment will be carried out through different communication channels, including informative posters distributed in the dental clinics of UnG, digital dissemination on the university's official website and its institutional social networks, direct invitation to patients who are on the waiting list of the periodontics clinic, and dissemination by the professors of the undergraduate and graduate clinics. All promotional materials will clearly state the inclusion and exclusion criteria, as well as provide contact information for scheduling, initial screening, and the ethics committee approval number. All participants will attend the Center for Clinical Studies of Univeritas UnG.
Who may be able to join
- Presence of at least 20 natural teeth
- Visible plaque index > 20% at initial assessment
- Age between 18 and 65 years
- Both sexes eligible
Who cannot join
- Use of fixed orthodontic appliances
- Presence of extensive restorations or fixed dentures on the anterior teeth
- Systemic conditions that interfere with the formation of dental biofilm
- Use of medications that alter salivary flow
Trial locations and contacts
1 site in 1 country.
About this study
This diagnostic validation study aims to develop and validate a digital method for dental biofilm quantification using three-dimensional images obtained by an intraoral scanner. Twenty participants will undergo intraoral scanning at three time points: before and after plaque disclosure, and after supervised toothbrushing. The digital method's accuracy will be compared with traditional clinical assessment methods (Turesky Plaque Index).
Read the detailed description
A prospective, evaluator-blinded clinical study including 20 participants (18-65 years) with at least 20 natural teeth and a visible plaque index >20%. Participants will be evaluated at three time points in a single session using TRIOS 4 intraoral scanner. Digital analysis will be performed using Geomagic Control X software to calculate the percentage of surface area covered by plaque. The study includes standardized intraoral photographs and supervised toothbrushing procedures. This digital method aims to provide a more objective and precise assessment of dental biofilm, overcoming limitations of conventional visual assessment methods.
- Conditions
- Dental Plaque (Diagnosis), Dental Plaque Imaging Methods, Dental Plaque, Gingivitis, Periodontal Disease
- Being tested
- Digital plaque quantification using intraoral scanner
- Keywords
- Dental Biofilm, Intraoral Scanner, Preventive Dentistry, Plaque quantification, Digital Diagnosis
- Medical subject headings
- Dental Plaque, Disease, Gingivitis, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital plaque quantification using intraoral scannerDiagnostic test
Participants will undergo three-dimensional intraoral scanning at three time points during a single session: initial scanning (T0), after biofilm disclosure with plaque disclosing solution (T1), and after supervised toothbrushing (T2).
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between digital 3D intraoral scans and traditional plaque assessment methods
Correlation between the percentage of dental surface area covered by biofilm quantified by the digital method (intraoral scanner) and the plaque index obtained by the traditional clinical method (Quigley-Hein Plaque Index modified by Turesky)
Measured: Single session (approximately 1.5-2 hours)
Secondary outcomes (4)
Correlation between digital 2D images and traditional plaque assessment methods
Correlation between the percentage of dental surface area covered by biofilm quantified by intraoral photographs with different filters and the plaque index obtained by the traditional clinical method (Quigley-Hein Plaque Index modified by Turesky)
Measured: Single session (approximately 1.5-2 hours)
Fluorescence imaging capabilities
Detection sensitivity for plaque, correlation with clinical findings, and reproducibility of fluorescence measurements.
Measured: Single session (approximately 1.5-2 hours)
Plaque volume changes analysis
Ability of the digital method to detect changes in the amount of biofilm, evaluated by the percentage difference in area covered between T0 (initial), T1 (after disclosure) and T2 (after professional brushing).
Measured: Single session (approximately 1.5-2 hours)
Plaque thickness changes analysis
Ability of the digital method to detect changes in the amount of biofilm, evaluated by the color map difference in area covered between T0 (initial), T1 (after disclosure), and T2 (after professional brushing), and correlating those with other features, such as disclosing agent color and fluorescence.
Measured: Single session (Approximately 1.5-2 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start19 Sep 2025
- Primary completion4 Oct 2025
- Study completion4 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental Plaque (Diagnosis)Studies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guarulhos
- Sponsor type
- University, hospital or other
- Collaborators
- Colgate Palmolive
- Responsible party
- Principal investigator, MOHAMED AHMED HASSAN, University of Guarulhos
- Investigators
- Mohamed A Hassan, PhD, Principal investigator, University of Guarulhos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07152314
- Sponsor's protocol ID
- 85446624.8.0000.5506
- Status last verified
- Sep 2026
- First submitted
- 21 Aug 2025
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be available for sharing based on a reasonable request
Publications
Del Rey YC, Rikvold PD, Johnsen KK, Schlafer S. A fast and reliable method for semi-automated planimetric quantification of dental plaque in clinical trials. J Clin Periodontol. 2023 Mar;50(3):331-338. doi: 10.1111/jcpe.13745. Epub 2022 Nov 28.
PubMed 36345833
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Quantification of Dental Plaque Based on Intraoral Scanner Images
- ClinicalTrials.gov ID
- NCT07152314
- Acronym / sponsor ID
- 85446624.8.0000.5506
- Conditions
- Dental Plaque (Diagnosis), Dental Plaque Imaging Methods, Dental Plaque, Gingivitis, Periodontal Disease
- Keywords
- Dental Biofilm, Intraoral Scanner, Preventive Dentistry, Plaque quantification, Digital Diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of GuarulhosUniversity, hospital or other
- Collaborators
- Colgate Palmolive
- Study start
- 19 Sep 2025 (actual)
- Primary completion
- 4 Oct 2025 (actual)
- Study completion
- 4 Oct 2025 (actual)
- First posted
- 3 Sep 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.
This diagnostic validation study aims to develop and validate a digital method for dental biofilm quantification using three-dimensional images obtained by an intraoral scanner. Twenty participants will undergo intraoral scanning at three time points: before and after plaque disclosure, and after supervised toothbrushing. The digital method's accuracy will be compared with traditional clinical assessment methods (Turesky Plaque Index).
Detailed description
A prospective, evaluator-blinded clinical study including 20 participants (18-65 years) with at least 20 natural teeth and a visible plaque index >20%. Participants will be evaluated at three time points in a single session using TRIOS 4 intraoral scanner. Digital analysis will be performed using Geomagic Control X software to calculate the percentage of surface area covered by plaque. The study includes standardized intraoral photographs and supervised toothbrushing procedures. This digital method aims to provide a more objective and precise assessment of dental biofilm, overcoming limitations of conventional visual assessment methods.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Recruitment will be carried out through different communication channels, including informative posters distributed in the dental clinics of UnG, digital dissemination on the university's official website and its institutional social networks, direct invitation to patients who are on the waiting list of the periodontics clinic, and dissemination by the professors of the undergraduate and graduate clinics. All promotional materials will clearly state the inclusion and exclusion criteria, as well as provide contact information for scheduling, initial screening, and the ethics committee approval number. All participants will attend the Center for Clinical Studies of Univeritas UnG.
Key inclusion criteria (4 listed)
- Presence of at least 20 natural teeth
- Visible plaque index > 20% at initial assessment
- Age between 18 and 65 years
- Both sexes eligible
Key exclusion criteria (4 listed)
- Use of fixed orthodontic appliances
- Presence of extensive restorations or fixed dentures on the anterior teeth
- Systemic conditions that interfere with the formation of dental biofilm
- Use of medications that alter salivary flow
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 |
|---|---|---|
| Digital plaque quantification using intraoral scannerParticipants will undergo three-dimensional intraoral scanning at three time points during a single session: initial scanning (T0), after biofilm disclosure with plaque disclosing solution (T1), and after supervised toothbrushing (T2). | Diagnostic test | – |
Primary outcome
Correlation between digital 3D intraoral scans and traditional plaque assessment methods
Time frame: Single session (approximately 1.5-2 hours)
Correlation between the percentage of dental surface area covered by biofilm quantified by the digital method (intraoral scanner) and the plaque index obtained by the traditional clinical method (Quigley-Hein Plaque Index modified by Turesky)
4 secondary outcomes
Correlation between digital 2D images and traditional plaque assessment methods
Time frame: Single session (approximately 1.5-2 hours)
Fluorescence imaging capabilities
Time frame: Single session (approximately 1.5-2 hours)
Plaque volume changes analysis
Time frame: Single session (approximately 1.5-2 hours)
Plaque thickness changes analysis
Time frame: Single session (Approximately 1.5-2 hours)
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 11 Sep 2026.
- Background: PubMed 36345833Del Rey YC, Rikvold PD, Johnsen KK, Schlafer S. A fast and reliable method for semi-automated planimetric quantification of dental plaque in clinical trials. J Clin Periodontol. 2023 Mar;50(3):331-338. doi: 10.1111/jcpe.13745. Epub 2022 Nov 28.
- Individual participant dataSharing planned: No. IPD will be available for sharing based on a reasonable request
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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.
Mohamed A Hassan, PhD principal investigator
University of Guarulhos
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 (Diagnosis) and Dental Plaque Imaging Methods, run by University of Guarulhos at 1 site in Brazil.
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 4 inclusion and 4 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 11 Sep 2026. 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 Brazil. 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?
Correlation between digital 3D intraoral scans and traditional plaque assessment methods (time frame: Single session (approximately 1.5-2 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07152314, which also lists 1 linked publication.
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 11 Sep 2026.