Optical Coherence Tomography (OCT) Based Intraoral Scanner

Not yet recruiting

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

• Registration Number: NCT07092592
• Lead Sponsor: Perceptive Technologies, Inc

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-16
• Study First Submitted QC: 2025-07-25
• Last Update Submitted: 2025-07-25
• Study First Posted: 2025-07-30
• Last Update Posted: 2025-07-30
• Study Start: 2025-08-07
• Primary Completion: 2025-10
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intra-method reliability/repeatability testing	Up to 24 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Structure assessments	Up to 24 weeks	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.

Trial Locations

Locations (1)

The ADA Forsyth Institute; 🇺🇸 Somerville, Massachusetts, United States