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Clinical study of iTero scanners for early diagnosis of proximal caries

Clinical study of iTero scanners for early diagnosis of proximal caries

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300074877
Enrollment
Unknown
Registered
2023-08-18
Start date
2023-09-01
Completion date
Unknown
Last updated
2023-08-21

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

Conditions

Caries

Interventions

Gold Standard:Bitewing X-Ray
Index test:Near infrared light in iTero intraoral scanner

Sponsors

Zhejiang Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Using visual diagnosis, probing, X-ray examination, tooth division and other methods to carefully examine the teeth, diagnose the proximal caries or healthy teeth, the proximal caries diagnosis criteria are chalky or brown change on the adjacent surface of the teeth, the surface is not smooth, or cavities appear, combined with X-ray examination to find the shadows in the enamel or dentin of the adjacent surface of the teeth (2) The teeth are premolar or molar, excluding wisdom teeth (3) The teeth are untreated, no filling and restoration, no pulp, periapical and periodontal diseases (4) Age = 18 years, male and female are not limited (5) general oral hygiene conditions (6) Good general condition, assessed to be able to tolerate invasive dental operations (7) Have signed the informed consent

Exclusion criteria

Exclusion criteria: (1) Any systemic disease that may contraindicate invasive dental operations, such as severe brain, liver, lung, kidney insufficiency; physical disability; with other mental illnesses, speech and communication disorders; unable to assess the results (2) The teeth are milk teeth, front teeth, multiple teeth or wisdom teeth (3) The teeth have been treated (including prophylactic treatment, such as sulcus closure), and fillings and restorations are present (4) The teeth have pulpal, periapical and periodontal diseases (5) Poor oral hygiene or inability to maintain oral hygiene as prescribed by the doctor (6) Drug addicts or drug dependents, smokers >10 cigarettes/day or alcoholics (7) Pregnant or breastfeeding women

Design outcomes

Primary

MeasureTime frame
consistence;

Secondary

MeasureTime frame
sensitivity;accuracy;specificity;

Countries

China

Contacts

Public ContactLiheng Shen

Zhejiang Provincial People's Hospital

shenlh22@163.com+86 183 6884 6782

Outcome results

None listed

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