Optical Coherence Tomography (OCT) Based Intraoral Scanner

NCT07092592 | Not Yet Recruiting

• 2 other identifiers: PerceptiveTech1R44DE033316
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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:

1. 1.to correct for distortion caused by internal refractive indices to restore true tooth anatomy
2. 2.to test the feasibility and usability of the full-motion OCT scanner in volunteers.
3. 3.Some teeth that are extracted according standard treatment plan will be scanned with OCT.
4. 4.Some participants will have their teeth and gum in the mouths scanned by OCT

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

Outcome Measures

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.

  Up to 24 weeks

Secondary Outcomes (1)

• Structure assessments

  Up to 24 weeks

Eligibility Criteria

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

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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Perceptive Technologies, Inc: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator
• The Forsyth Institute: collaborator

Study Sites (1)

The ADA Forsyth Institute

Somerville, Massachusetts, 02143, United States

Location

Central Study Contacts

Hatice Hasturk

CONTACT

617-892-8248; hhasturk@forsyth.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: July 30, 2025
• Study Start: August 7, 2025
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)