Digital Quantification of Dental Plaque Based on Intraoral Scanner Images

NCT ID: NCT07152314

Last Updated: 2025-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-30

Study Completion Date

2026-08-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Interventions

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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).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Guarulhos

OTHER

Sponsor Role lead

Responsible Party

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MOHAMED AHMED HASSAN

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed A Hassan, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Guarulhos

Locations

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University of Guarulhos

Guarulhos, São Paulo, Brazil

Site Status

Countries

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Brazil

Central Contacts

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Mohamed A Hassan, PhD

Role: CONTACT

+55 (11) 972945957

Facility Contacts

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Mohamed A Hassan, PhD

Role: primary

+55 (11) 972945957

Jose A Rodrigues, PhD

Role: backup

+55 (11)2464-1664

References

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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.

Reference Type BACKGROUND
PMID: 36345833 (View on PubMed)

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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85446624.8.0000.5506

Identifier Type: -

Identifier Source: org_study_id

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