Automated Quantification of Dental Plaque | NCT06789835

Studies
Automated Quantification of Dental Plaque

NCT06789835

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Jan 23, 2025Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Dental Plaque

Interventions

Fluorescence imaging of disclosed and undisclosed plaque

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 17, 2023Actual

Primary Completion Date

Jan 30, 2024Actual

Completion Date

Jan 30, 2024Actual

First Submitted Date

Dec 19, 2024

First Submission Date that Met QC Criteria

Jan 16, 2025

First Posted Date

Jan 23, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 16, 2025

Last Update Posted Date

Jan 23, 2025Actual

Name	Class
3Shape A/S	INDUSTRY
National and Kapodistrian University of Athens	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study generates data that contribute to the development and validation of an automated approach to full-mouth quantification of dental plaque, based on fluorescence images and intraoral scans of teeth with disclosed and undisclosed plaque.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fluorescence imaging of disclosed and undisclosed plaque			Device: Fluorescence imaging of disclosed and undisclosed plaque

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fluorescence imaging of disclosed and undisclosed plaque	Device	Teeth are imaged using a fluorescence camera/an intraoral scanner before and after plaque disclosure.	Fluorescence imaging of disclosed and undisclosed plaque

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Planimetric plaque index	Plaque area coverage of teeth	1 day

Secondary Outcomes

Measure	Description	Time Frame
Turesky modification of the Quigley and Hein Plaque Index	Plaque coverage of teeth	1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males and females ≥ 18 years old Presence of at least one tooth Anatomically possible to perform intraoral imaging Subjects need to be able to understand and follow instructions, as well as to read and sign the informed consent form

Exclusion Criteria:

History of allergies towards any of the ingredients in the disclosing agents Self-reported serious medical conditions

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adults

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sebastian Schlafer, DDS	University of Aarhus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Dentistry and Oral Health, Aarhus University		Aarhus		8000	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Due to general data protection regulations, individual participant data will not be made available publicly. Summary data will be made available upon publication of the results.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003773	Dental Plaque

Ancestor Terms

ID	Term
D003741	Dental Deposits
D014076	Tooth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided