Digital Quantification of Dental Plaque Based on Intraoral Scanner Images

NCT07152314 | Not Yet Recruiting

• 1 other identifier: 85446624.8.0000.5506
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Dental Plaque (Diagnosis); Dental Plaque Imaging Methods; Dental Plaque; Gingivitis; Periodontal Disease

Keywords

Dental Biofilm; Intraoral Scanner; Preventive Dentistry; Plaque quantification; Digital Diagnosis

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (4)

• Correlation between digital 2D images and traditional plaque assessment methods

  Single session (approximately 1.5-2 hours)

• Fluorescence imaging capabilities

  Single session (approximately 1.5-2 hours)

• Plaque volume changes analysis

  Single session (approximately 1.5-2 hours)

• Plaque thickness changes analysis

  Single session (Approximately 1.5-2 hours)

Interventions

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).

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Guarulhos: lead

Study Sites (1)

University of Guarulhos

Guarulhos, São Paulo, 07.023-070, Brazil

Location

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Dental Plaque; Disease; Gingivitis; Periodontal Diseases

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Gingival Diseases; Mouth Diseases

Study Officials

• Mohamed A Hassan, PhD

  University of Guarulhos

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed A Hassan, PhD

CONTACT

+55 (11) 972945957; mohamed.hassan@prof.ung.br

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: September 3, 2025
• Study Start: September 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)