Skip to content

Efficacy and Safety Evaluation of CoreBone Bioactive Bone Graft in Promoting Reparative Bone Regeneration of Jaw Bone Defects: a Double-Center, Open, Randomized, Parallel Controlled Clinical Trial

Efficacy and Safety Evaluation of CoreBone Bioactive Bone Graft in Promoting Reparative Bone Regeneration of Jaw Bone Defects: a Double-Center, Open, Randomized, Parallel Controlled Clinical Trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200061852
Enrollment
Unknown
Registered
2022-07-04
Start date
2022-06-20
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

Bone Defects

Interventions

Test group and control group:Implanted Bone Meal Covered with Biofilm

Sponsors

Peking University Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-65 years, male or female; 2. Patients voluntarily participate in the trial and sign the informed consent form (ICF); 3. Patients requiring tooth extraction; 4. Patients with good oral hygiene habits; 5. The local wound, if any, can be completely closed by surgical suture.

Exclusion criteria

Exclusion criteria: 1. Patients with a history of osteoporosis and have received bisphosphonate therapy; 2. Patients with a history of chemotherapy and radiotherapy of maxillofacial, nasopharyngeal, neck within the past 5 years; 3. Patients have severe degenerative diseases; 4. Patients with local infection; 5. Patients with severe systemic diseases; 6. Patients with systemic or local bone diseases such as bone cyst, bone tuberculosis, osteitis, bone neoplasm, etc.; 7. Pregnant or lactating women; 8. Patients with pregnancy plans within 6 months; 9. Long-term use of special drugs such as hormones, anticoagulants, etc.; 10. Patients with psychosis, psychological disorders and neurological diseases, such as epilepsy; 11. Patients with endocrine and metabolic diseases, blood system diseases and uncontrolled cardiovascular disorders; 12. Patients who smoke more than ten cigarettes per day or have very poor oral hygiene habits; 13. Patients with severe bone defects; 14. Diabetic patients; 15. Subjects with severe allergic constitution; 16. Other conditions considered unsuitable for participation in the trial by the investigator.

Design outcomes

Primary

MeasureTime frame
The change value of alveolar ridge height at immediate postoperative time and at 6 months after surgery;wound healing at 1 week, 1 month, 3 months and 6 months after surgery;The change value of alveolar ridge width at immediate postoperative time and at 6 months after surgery;

Countries

China

Contacts

Public ContactWang Xiao

Peking University Third Hospital

bysywangxiao@163.com+86 13601067229

Outcome results

None listed

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