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Not yet recruiting NCT07092592

Optical Coherence Tomography (OCT) Based Intraoral Scanner

Observational 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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry 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. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Primary outcome measures

  • Intra-method reliability/repeatability testing [Time frame: Up to 24 weeks]
Secondary outcome measures (1)
  • Structure assessments [Time frame: Up to 24 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-only

Study locations

United States · 1 center
  • The ADA Forsyth Institute — Somerville

Identifiers

NCT: NCT07092592 · PerceptiveTech · 1R44DE033316

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗