Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2025-12-24 @ 10:29 PM
NCT ID:
NCT05371535
Eligibility Criteria:
Inclusion Criteria:
1. Male or female patients aged 18-65 years (including 18 years and 65 years);
2. Bone loss caused by singe tooth extraction requiring bone grafting;
3. At least one natural tooth adjacent to the targeted tooth;
4. The subjects could understand the purpose of this trial, voluntarily participate in this trial and willing to sign an Informed Consent Form (ICF).
Exclusion Criteria:
1. Bone defect caused by invasive or malignant bone tumors；
2. Subjects with uncontrolled periodontitis, acute periapical inflammation;
3. Subjects who are receiving or had received any drug in last 3 months that may influence or promote bone metabolism;
4. Active infectious disease, various bone defects during the active phase of metabolic bone disease;
5. Subjects with acute or chronic infection (osteomyelitis) at the surgical site;
6. Subjects with osteoporosis or osteomalacia;
7. Alanine Aminotransferase，ALT）Aspartate Aminotransferase，AST） Subjects with abnormal liver or kidney functions (ALT or AST or creatinine exceeds 1.5 times the upper limit of normal range);
8. Subjects who has a history of or is undergoing cervico-facial radiotherapy or chemotherapy;
9. Subjects with serious blood system diseases, such as leukemia or other hemorrhagic diseases;
10. Subjects with abnormal coagulation function;
11. Subjects with severe cardiovascular and cerebrovascular diseases;
12. Subjects with systemic diseases may affect postoperative healing and/or osseointegration, such as diabetes, uncontrolled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg), hyperparathyroidism, etc.
13. Subjects with mental disorder and lack of behavioral autonomy;
14. Known allergy or hypersensitivity to animal-derived implantable materials;
15. Subjects who refuse to use porcine-derived implantable materials;
16. Pregnant and lactating women, or those who plan to conceive within 6 months;
17. Subjects with implants adjacent to the targeted teeth that can cause oral imaging artifacts, such as metal dentures, porcelain teeth, etc. that may cause oral imaging artifacts;
18. Subjects who smoking more than 5 cigarettes per day;
19. Subjects who are alcoholism, drug abuse, or drug dependence;
20. Subjects who have participated or are participating in a drug clinical trials in last 3 months, or have participated in other medical device clinical trials in last 30 days;
21. Other circumstances which are considered by the investigator not suitable for enrollment in this study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05371535
Study Brief:
Protocol Section:
NCT05371535