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NCT Number: NCT07092592

Optical Coherence Tomography (OCT) Based Intraoral Scanner

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

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Key information

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Intra-method reliability/repeatability testing

    Time frame: 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 outcomes

  1. Structure assessments

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hatice Hasturk

CONTACT

[email protected]

617-892-8248

Sponsors and collaborators

Lead sponsor

Perceptive Technologies, Inc

Industry

Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)
  • The Forsyth Institute

Registry information

Official study title

Developing an Optical Coherence Tomography (OCT) Based Handheld Intraoral Scanner for Dentistry

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 30, 2025
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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