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NCT Number: NCT07152314

Digital Quantification of Dental Plaque Based on Intraoral Scanner Images

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).

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Key information

Conditions

Dental Plaque (Diagnosis) Dental Deposits Dental Plaque Dental Plaque Imaging Methods Disease Gingival Diseases Gingivitis Infections Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Disease Periodontal Diseases Stomatognathic Diseases Tooth Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. 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)

Secondary outcomes

  1. Correlation between digital 2D images 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 intraoral photographs with different filters and the plaque index obtained by the traditional clinical method (Quigley-Hein Plaque Index modified by Turesky)

  2. Fluorescence imaging capabilities

    Time frame: Single session (approximately 1.5-2 hours)

    Detection sensitivity for plaque, correlation with clinical findings, and reproducibility of fluorescence measurements.

  3. Plaque volume changes analysis

    Time frame: 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).

  4. Plaque thickness changes analysis

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed A Hassan, PhD

CONTACT

[email protected]

+55 (11) 972945957

Sponsors and collaborators

Lead sponsor

University of Guarulhos

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 3, 2025
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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