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Microecological Changes in Oral Leukoplakia and Oral Squamous Cell Carcinoma Associated with Diabetes: A Case-Control Study

Microecological Changes in Oral Leukoplakia and Oral Squamous Cell Carcinoma Associated with Diabetes: A Case-Control Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500105246
Enrollment
Unknown
Registered
2025-07-01
Start date
2025-07-02
Completion date
Unknown
Last updated
2025-07-07

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

Conditions

oral leukoplakia

Interventions

control group with diabetes:None
Control group without diabetes:None
Oral leukoplakia group with diabetes:None
Oral leukoplakia group without diabetes:None
Oral squamous cell carcinoma group with diabetes:None
Oral squamous cell carcinoma group without diabetes:None

Sponsors

Peking University School and Hospital of Stomatology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1. Group of OLK patients with or without DM: (1) Fulfillment of the above diagnostic criteria for OLK with (in the group with DM) or without (in the group without DM) DM. (2) No malignant transformation had occurred. (3) No other oral mucosal diseases. (4) Patients were over 18 years of age and of either sex. (5) Have signed an informed consent to participate in the study. 2. Group of OSCC patients with or without DM: Patients who met the above diagnostic criteria for OSCC, or those who had malignant transformation of part of the OLK into OSCC, and who also met (in the group with DM) or did not meet (in the group without DM) the diagnostic criteria for DM. (2) No other oral mucosal diseases. (3) Patients were over 18 years of age and of any gender. (4) Have signed the informed consent to participate in the study. 3. Healthy controls with or without DM: (1) Fulfillment of the diagnostic criteria for DM (in the group with DM) or not (in the group without DM). (2) No oral mucosal disease. (3) Patients were over 18 years old and of either sex. (4) Have signed the informed consent form and agreed to participate in the study.

Exclusion criteria

Exclusion criteria: (1) Patients with malignant transformation of some areas of OLK into OSCC who have had surgical removal of OSCC lesions. (2) Chronic disease: patients with other serious systemic diseases (e.g., cancer, cardiovascular disease, etc.) that may affect the oral microbiota. (3) Oral disease: patients with severe periodontal disease, dental caries or other oral diseases. (4) Antibiotic use: patients who have used antibiotics or other medications that may affect the oral microbiota within the past 1 month. (5) Immune system disorders: diagnosis of immune system disorders such as systemic lupus erythematosus. (6) Other factors: pregnancy, lactating women, or any other factors that may interfere with the results of the study.

Design outcomes

Primary

MeasureTime frame
macro-genome ;metabolomics;viral detection;

Countries

China

Contacts

Public ContactZhou Peiru

Peking University School and Hospital of Stomatology

zhoupeiru1989@163.com+86 10 8219 5806

Outcome results

None listed

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