Optical Coherence Tomography (OCT) Based Intraoral Scanner | NCT07092592

Studies
Optical Coherence Tomography (OCT) Based Intraoral Scanner

NCT07092592

Sponsor

Perceptive Technologies, Inc

Status

Not yet recruiting

Last Update Posted

Jul 30, 2025Actual

Enrollment

70Estimated

Phase

Not provided

Conditions

The Focus of the Study is to Evaluate the Efficacy of OCT in Scanning and Reconstructing General Tooth and Gum Anatomy
Tooth Anatomy
Gingival Anatomy

Interventions

Not provided

Countries

United States

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

ID	Type	Description	Link
1R44DE033316	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 7, 2025Estimated

Primary Completion Date

Oct 2025Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Jun 16, 2025

First Submission Date that Met QC Criteria

Jul 25, 2025

First Posted Date

Jul 30, 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

Jul 25, 2025

Last Update Posted Date

Jul 30, 2025Actual

Name	Class
National Institute of Dental and Craniofacial Research (NIDCR)	NIH
The Forsyth Institute	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this study is to optimize the matching between Optical Coherence Tomography (OCT) imaging and the true anatomy of the tooth. It also non-invasively tests how reliable the OCT scanner can access tissue integrity, measure depth, and detect texture features. These features will be important to plan for treatment. The specific aims of this study are:

to correct for distortion caused by internal refractive indices to restore true tooth anatomy
to test the feasibility and usability of the full-motion OCT scanner in volunteers.

Participants may be in one of the following groups

Some teeth that are extracted according standard treatment plan will be scanned with OCT.
Some participants will have their teeth and gum in the mouths scanned by OCT

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

70Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intra-method reliability/repeatability testing	Intra-class correlation coefficients will be calculated for tissue characteristics listed above will be determined by the OCT scanner on group of teeth (full-arch), single tooth and subgingival surfaces.	Up to 24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Structure assessments	Extracted teeth will be scanned with the OCT scanner. The air-enamel interface and the internal structure (e.g. Dentin-Enamel Junction) will be detected in the OCT reconstructed images. The ground truth of the anatomy will be provided by histology or micro-CT. The OCT reconstructed anatomy will be compared to the ground truth to understand the accuracy of the OCT scanner.	Up to 24 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Willing and able to agree by the terms of the consent form and sign the Informed Consent form
Aged 18 years old and older
Individuals with a minimum of 18 natural teeth present including teeth from distinct groups (molar, premolar and anterior teeth).
Having healthy dentition (small carious lesions and dental restorations not covering the entire surface of the tooth will be accepted) as determined by the dental clinician
Willing to have a retraction cord placed under the gumline for a duration of 2 min.
Having a tooth that requires crown procedure according to treatment planning by the patients' clinician (for real-time scanning)

Exclusion Criteria:

Pregnant women
Generalized gingivitis and periodontal disease
Extensive dental work including dental fillings, crowns and implants and extensive tooth damage (i.e., fracture, large dental caries, etc.)
Presence of fixed orthodontic braces, or lingual bars (only for in vivo studies)
Presence of generalized (or on target teeth) supra and subgingival calculus

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

All study participants will be recruited at the Forsyth Center for Clinical and Translational Research and Forsyth Faculty Associates Clinics (those scheduled for tooth extractions). Potentially eligible participants will be invited to the initial screening visit, in which they will be asked to complete medical and dental history, and will undergo a clinical examination. After selection of those who fulfill the inclusion and exclusion criteria, study participants will be provided with details of the trial.

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Hatice Hasturk	Contact	617-892-8248		hhasturk@forsyth.org

Facility	Status	City	State	ZIP	Country	Contacts
The ADA Forsyth Institute		Somerville	Massachusetts	02143	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

The IPD will be for internal use only.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided