A randomized, blind, parallel, positive control and multicenter clinical study to evaluate the effectiveness and safety of absorbable bone grafting materials OCS-B applied to the alveolar bone defect

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-IIR-17013312

Enrollment

Unknown

Registered

2017-11-09

Start date

2016-07-27

Completion date

Unknown

Last updated

2017-11-13

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

Conditions

alveolar bone defect

Interventions

Experiment Group:Implanted OCS-B

Control Group:Implanted Geistlich Bio-Oss

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 65 years old male and female; 2. Bone graft is needed after a single tooth extraction; 3. Bone defect =5mm; 4. Endorsement of the informed consent.

Exclusion criteria

Exclusion criteria: 1. Involvement of another clinical trial within 3 months; 2. Bone defect arising from invasive, malignant bone tumors; 3. Progressive periodontal disease; 4. Receiving medications which may affect or promote bone metabolism within 3 months; 5. Bone defect arising from active infectious disease or metabolic bone disease; 6. Cardiac disease (NYHA II or above); 7. Abnormal function of liver or kidney (ALTAST 2 times higher than normal or abnormal creatinine); 8. Poor control of diabetes (FPG=8.0mmol/L); 9. Mental disorder without autonomous ability; 10. Allergic constitution; 11. Pregnancy or lactation; 12. Other condition causing false images such as metal denture, porcelain tooth and so on.

Design outcomes

Secondary

Measure	Time frame
Clinical surgical incision healing evaluation;Rejection reaction;Bone metabolism;Symptoms after implant;Bone infection;	—

Primary

Measure	Time frame
Imageology diversity;	—

Countries

China

Contacts

Public ContactKaijin Hu

School of Stomotology, The Fourth Military Medical University

hukaijin@fmm.edu.cn+86 13991106298

Outcome results

None listed

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