Skip to content

Clinical Investigation of Oral Mucosal Immune Activation via Engineered Polyantigen Granules

Clinical Investigation of Oral Mucosal Immune Activation via Engineered Polyantigen Granules

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099151
Enrollment
Unknown
Registered
2025-03-19
Start date
2025-04-01
Completion date
Unknown
Last updated
2026-08-10

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

Conditions

Periodontitis

Interventions

Intervention group:Two sublingual mucosal interventions were performed on enrolled volunteers with an interval of two weeks. The specific operation process is as follows: The engineered polyantigen gr

Sponsors

Jinan Stomatological Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Clinically recruited volunteers aged 20-50 years, with no restrictions on gender. 2. All subjects provided voluntary informed consent and were anticipated to have high compliance.

Exclusion criteria

Exclusion criteria: 1. Patients who have previously received oral surgery or have intraoral prosthetics that may interfere with the evaluation of the test indicators; 2. Systolic blood pressure >180 mmHg, or diastolic blood pressure >110 mmHg; 3. Systemic diseases (autoimmune diseases, malignant tumors, diabetes patients, heart failure due to heart disease, myocardial infarction within six months, angina symptoms within six months, congenital heart disease, etc.); 4. People who are using non-steroidal anti-inflammatory drugs, bisphosphonates or corticosteroids; 5. Patients with bleeding tendency or coagulation disorder (WBC < 3.0×10^9/L or platelet count PLT < 60×10^9/L); 6. Persons infected with HIV or hepatitis B virus; 7. Pregnant or lactating women, women planning to become pregnant within 6 months or women using estrogen contraception; 8. Patients with a history of alcoholism, intravenous drug addiction, mental or intellectual impairment; 9. Patients with abnormal immune function or autoimmune diseases; 10. People who have received other vaccines in the last 6 months.

Design outcomes

Primary

MeasureTime frame
Vital signs, including body temperature, blood pressure and heart rate;Oral mucosal examination;Complete blood count;Blood biochemical parameters;Adverse events considered related to SHIELD administration;

Secondary

MeasureTime frame
P. gingivalis-specific salivary sIgA level;Submandibular lymph-node ultrasound;

Countries

China

Contacts

Public ContactYitong Liu

Jinan Stomatological Hospital

15010546495@163.com+86 150 1054 6495

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 25, 2026