Periodontitis
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time frame |
|---|---|
| P. gingivalis-specific salivary sIgA level;Submandibular lymph-node ultrasound; | — |
Countries
China
Contacts
Jinan Stomatological Hospital