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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).
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital plaque quantification using intraoral scanner | Diagnostic 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Single session (approximately 1.5-2 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Single session (approximately 1.5-2 hours) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamed A Hassan, PhD | Contact | +55 (11) 972945957 | mohamed.hassan@prof.ung.br |
| Name | Affiliation | Role |
|---|---|---|
| Mohamed A Hassan, PhD | University of Guarulhos | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Guarulhos | Guarulhos | São Paulo | 07.023-070 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36345833 | Background | 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. |
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IPD will be available for sharing based on a reasonable request
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Mar 25, 2025 | Aug 28, 2025 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D003773 | Dental Plaque |
| D004194 | Disease |
| D005891 | Gingivitis |
| D010510 | Periodontal Diseases |
| ID | Term |
|---|---|
| D003741 | Dental Deposits |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D010335 | Pathologic Processes |
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| Fluorescence imaging capabilities | Detection sensitivity for plaque, correlation with clinical findings, and reproducibility of fluorescence measurements. | 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). | 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. | Single session (Approximately 1.5-2 hours) |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D009059 | Mouth Diseases |