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Efficacy and safety of an artificial bone graft substitutes in alveolar ridge preservation: Multicentre, open-label, Randomized, Parallel arm clinical trial

Efficacy and safety of an artificial bone graft substitutes in alveolar ridge preservation: Multicentre, open-label, Randomized, Parallel arm clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098444
Enrollment
Unknown
Registered
2025-03-07
Start date
2024-01-24
Completion date
Unknown
Last updated
2025-03-10

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

Conditions

Alveolar bone defects

Interventions

Experimental group:Implant BpNcCaP
Control group:Implant Bio-Oss

Sponsors

West China Hospital of stomatology, Si Chuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Male or female between 18 and 70; 2. Need at least one tooth extraction and the present of one healthy adjacent tooth at the extraction site; 3. Signed informed consent form; 4. Have good oral hygiene habits.

Exclusion criteria

Exclusion criteria: 1. Liver and kidney function were obviously abnormal (AST, ALT, creatinine >= 1.5 times the upper limit of normal); 2. Coagulation disorders (APTT, PT, and FIB values are >= 1.5 times the upper limit of normal values); 3. Have a history of osteoporosis or are taking bisphosphonate therapy affecting bone regeneration; 4. History of radiotherapy and chemotherapy for maxillofacial,nasopharyngeal,or head and neck; 5. Severe degenerative disease; 6. Uncontrolled or obvious infection in local areas; 7. Sever systemic diseases; 8. Have systemic or local bone diseases such as bone tuberculosis, osteitis, bone tumors, etc; 9. Pregnant or breast feeding; 10. Plan to get pregnant within 12 months; 11. Long-term use of special drugs such as hormones, anticoagulants, etc 12. Mental abnormality, psychological disorders, neurological diseases (e.g.,epilepsy, etc.); 13. Uncontrolled endocrine and metabolic diseases, blood system diseases and cardiovascular diseases; 14. Smokers (>10 cigarettes) or poor oral hygiene; 15. Uncontrolled metabolic diseases such as diabetes, rickets, and thyroid disease; 16. Severe allergies; 17. Other conditions unsuitable for participation in the trial.

Design outcomes

Primary

MeasureTime frame
Change in alveolar bone height;

Secondary

MeasureTime frame
Change in alveolar bone width;Implant area healing evaluation;

Countries

China

Contacts

Public ContactXian Liu

West China Stomatology Hospital, Sichuan University

jssyliuxian@163.com+86 138 8076 0220

Outcome results

None listed

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