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Clinical trial protocol for the efficacy and safety of Ultralucia OCT Stomatological Detector in the examination of oral mucosal lesions

Clinical trial protocol for the efficacy and safety of Ultralucia OCT Stomatological Detector in the examination of oral mucosal lesions

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100042788
Enrollment
Unknown
Registered
2021-01-28
Start date
2021-02-05
Completion date
Unknown
Last updated
2021-05-10

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

Conditions

oral leukoplakia, Oral lichen planus, Oral submucosal fibrosis

Interventions

Gold Standard:Pathological results of tissue biopsy
Index test:Ultralucia&#32
OCT&#32
examination&#32
results

Sponsors

Beijing Stomatological Hospital of Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Clinically diagnosed as oral leukoplakia, lichen planus or typical submucosal fibrosis. 2.Aged 18 to 70 years. 3.Those who can receive pathological biopsy to get definite diagnosis results. 4.Without other surgical treatment. 5.No treatment such as drug, laser or radiotherapy within a month. 6.Subjects were informed and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1.Patients with serious uncontrolled diabetes, hypertension, heart disease, mental illness and other systemic diseases, and can not tolerate biopsy. 2.Participants deemed unsuitable by the investigator to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Ultralucia OCT examination;SEN, SPE, ACC, AUC of ROC;—

Countries

China

Contacts

Public ContactXiaoan Tao
taoxiaoa@mail.sysu.edu.cn+86 20-83863002

Outcome results

None listed

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