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Optical Coherence Tomography (OCT) Based Intraoral Scanner

P

Perceptive Technologies, Inc

Status

Not yet enrolling

Conditions

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

Study type

Observational

Funder types

Other
Industry
NIH

Identifiers

NCT07092592
PerceptiveTech
1R44DE033316 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Enrollment

70 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Hatice Hasturk

Data sourced from clinicaltrials.gov

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