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Application of the prototype of an intraoral OCT probe for noninvasive assessment of carious/noncarious lesions and restorations/therapeutic procedures

Application of the prototype of an intraoral OCT probe for noninvasive assessment of carious/noncarious lesions and restorations/therapeutic procedures - IIT OCT

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00029748
Enrollment
80
Registered
2022-08-10
Start date
2023-02-15
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

K003, 009, 004, 02, 03, 05, 06, 08

Interventions

Group 1: Diagnosis and assessment of all healthy/(initially)carious/eroded/defective tooth surfaces using the established clinical procedures (Ia). Group 2: Assessment of all treated tooth surfaces us

Sponsors

Universität Leipzig
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Subject-related criteria: patient appears as part of planned dental visit (no additional appointment) / patient must be 18 years of age or older / signed consent for the use of the intraoral OCT probe has been obtained (Annex 5). 2. Tooth-related criteria: positive sensitivity (testing with CO2 snow) / healthy tooth surface or existing (initial)carious lesion, need for treatment in case of advanced carious lesions, continuous observation during removal of carious hard tooth substance (selective removal of caries) / restored tooth, monitoring of restoration / restoration margin discoloration, caries on the restoration margin

Exclusion criteria

Exclusion criteria: degree of loosening >1 / alcohol and drug dependent patients / not legally capable / patient does not appear additionally resilient, with need to escape or is irritated / pregnant/breastfeeding women / conflict of interest due to participation in another study is given / known allergy to ingredients of the materials used

Design outcomes

Primary

MeasureTime frame
In situ imaging of all tooth surfaces with the intraoral OCT probe and visualization of healthy/restored surfaces and carious/noncarious lesions.

Secondary

MeasureTime frame
1. OCT imaging of all healthy/(initial)carious/eroded/defective tooth surfaces and their classification according to established standards (scoring). 2. OCT imaging of the tooth-restoration interface/treated tooth surface (all tooth surfaces) and quantitative assessment of interfacial gap formation (selective for enamel/dentin/cement) or caries infiltration/remineralization.

Countries

Germany

Contacts

Public ContactRainer Haak, MME

Universitätsklinikum Leipzig, Poliklinik für Zahnerhaltung und Parodontologie

rainer.haak@medizin.uni-leipzig.de+49 341 97 21200

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026