Digital Quantification of Dental Plaque Based on Intraoral Scanner Images

Not yet recruiting

• Conditions: Dental Plaque (Diagnosis); Dental Plaque Imaging Methods; Dental Plaque; Gingivitis; Periodontal Disease

• Registration Number: NCT07152314
• Lead Sponsor: University of Guarulhos

Brief 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 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 Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-21
• Study First Submitted QC: 2025-08-28
• Last Update Submitted: 2025-08-28
• Study Start: 2025-09-01
• Study First Posted: 2025-09-03
• Last Update Posted: 2025-09-03
• Primary Completion: 2026-04
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Presence of at least 20 natural teeth
• Visible plaque index > 20% at initial assessment
• Age between 18 and 65 years
• Both sexes eligible

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between digital 3D intraoral scans and traditional plaque assessment methods	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)

Secondary Outcome Measures

Name	Time	Method
Correlation between digital 2D images and traditional plaque assessment methods	Single session (approximately 1.5-2 hours)	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)
Fluorescence imaging capabilities	Single session (approximately 1.5-2 hours)	Detection sensitivity for plaque, correlation with clinical findings, and reproducibility of fluorescence measurements.
Plaque volume changes analysis	Single session (approximately 1.5-2 hours)	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).
Plaque thickness changes analysis	Single session (Approximately 1.5-2 hours)	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.

Trial Locations

Locations (1)

University of Guarulhos; 🇧🇷 Guarulhos, São Paulo, Brazil