The Focus of the Study is to Evaluate the Efficacy of OCT in Scanning and Reconstructing General Tooth and Gum AnatomyNCT07092592
Optical Coherence Tomography (OCT) Based Intraoral Scanner
An observational study of The Focus of the Study is to Evaluate the Efficacy of OCT in Scanning and Reconstructing General Tooth and Gum Anatomy and Tooth Anatomy, run by Perceptive Technologies, Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- 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
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2025to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All study participants will be recruited at the Forsyth Center for Clinical and Translational Research and Forsyth Faculty Associates Clinics (those scheduled for tooth extractions). Potentially eligible participants will be invited to the initial screening visit, in which they will be asked to complete medical and dental history, and will undergo a clinical examination. After selection of those who fulfill the inclusion and exclusion criteria, study participants will be provided with details of the trial.
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The ADA Forsyth Institute
Somerville, Massachusetts, 02143
Hatice Hasturk, 617-892-8248, hhasturk@forsyth.org
About this study
Official title: Developing an Optical Coherence Tomography (OCT) Based Handheld Intraoral Scanner for Dentistry
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:
- to correct for distortion caused by internal refractive indices to restore true tooth anatomy
- to test the feasibility and usability of the full-motion OCT scanner in volunteers.
Read more
Participants may be in one of the following groups
- Some teeth that are extracted according standard treatment plan will be scanned with OCT.
- Some participants will have their teeth and gum in the mouths scanned by OCT
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-method reliability/repeatability testing
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.
Measured: Up to 24 weeks
Secondary outcomes (1)
Structure assessments
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.
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start7 Aug 2025 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Focus of the Study is to Evaluate the Efficacy of OCT in Scanning and Reconstructing General Tooth and Gum AnatomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Perceptive Technologies, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR), The Forsyth Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07092592
- Sponsor's protocol ID
- PerceptiveTech
- Other IDs
- 1R44DE033316
- Status last verified
- Jun 2025
- First submitted
- 16 Jun 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD will be for internal use only.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing an Optical Coherence Tomography (OCT) Based Handheld Intraoral Scanner for Dentistry
- ClinicalTrials.gov ID
- NCT07092592
- Acronym / sponsor ID
- PerceptiveTech
- 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 type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Perceptive Technologies, IncIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR), The Forsyth Institute
- Study start
- 7 Aug 2025 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- to correct for distortion caused by internal refractive indices to restore true tooth anatomy
- to test the feasibility and usability of the full-motion OCT scanner in volunteers.
Participants may be in one of the following groups
- Some teeth that are extracted according standard treatment plan will be scanned with OCT.
- Some participants will have their teeth and gum in the mouths scanned by OCT
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All study participants will be recruited at the Forsyth Center for Clinical and Translational Research and Forsyth Faculty Associates Clinics (those scheduled for tooth extractions). Potentially eligible participants will be invited to the initial screening visit, in which they will be asked to complete medical and dental history, and will undergo a clinical examination. After selection of those who fulfill the inclusion and exclusion criteria, study participants will be provided with details of the trial.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Structure assessments
Time frame: Up to 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Individual participant dataSharing planned: No. The IPD will be for internal use only.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of The Focus of the Study is to Evaluate the Efficacy of OCT in Scanning and Reconstructing General Tooth and Gum Anatomy and Tooth Anatomy, run by Perceptive Technologies, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hatice Hasturk (617-892-8248, hhasturk@forsyth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-method reliability/repeatability testing (time frame: Up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.