Optical Coherence Tomography (OCT) Based Intraoral Scanner

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPerceptive Technologies, Inc

About this trial

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:

1. to correct for distortion caused by internal refractive indices to restore true tooth anatomy 2. to test the feasibility and usability of the full-motion OCT scanner in volunteers.

Participants may be in one of the following groups

1. Some teeth that are extracted according standard treatment plan will be scanned with OCT. 2. Some participants will have their teeth and gum in the mouths scanned by OCT

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial 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.

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 24 weeks

Secondary outcomes

1

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.

Time frame
Up to 24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Perceptive Technologies, Inc

Lead sponsor

National Institute of Dental and Craniofacial Research (NIDCR)

Collaborator

The Forsyth Institute

Collaborator

This trial is not recruiting at the moment. You can still explore other options: