Optical Coherence Tomography (OCT) Based Intraoral Scanner

NCT ID: NCT07092592

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-07
• Study Completion Date: 2025-12-31

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. 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

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Dental and Craniofacial Research (NIDCR)

NIH

Sponsor Role: collaborator

The Forsyth Institute

OTHER

Sponsor Role: collaborator

Perceptive Technologies, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The ADA Forsyth Institute

Somerville, Massachusetts, United States

Countries

United States

Central Contacts

Hatice Hasturk

Role: CONTACT

hhasturk@forsyth.org

617-892-8248

Facility Contacts

Hatice Hasturk

Role: primary

hhasturk@forsyth.org

617-892-8248

Other Identifiers

1R44DE033316

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PerceptiveTech

Identifier Type: -

Identifier Source: org_study_id