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Not yet recruiting NCT07152314

Digital Quantification of Dental Plaque Based on Intraoral Scanner Images

Observational Dental Plaque (Diagnosis) Dental Plaque Imaging Methods Dental Plaque Gingivitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Digital plaque quantification using intraoral scanner.
Who it may be relevant to
Registry conditions: Dental Plaque (Diagnosis), Dental Plaque Imaging Methods, Dental Plaque, Gingivitis. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Diagnostic test Digital plaque quantification using intraoral scanner
    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 outcome measures

  • Correlation between digital 3D intraoral scans and traditional plaque assessment methods [Time frame: Single session (approximately 1.5-2 hours)]
Secondary outcome measures (4)
  • 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-crossover

Study locations

Brazil · 1 center
  • University of Guarulhos — Guarulhos

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. PMID 36345833

Identifiers

NCT: NCT07152314 · 85446624.8.0000.5506

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗