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A clinical study of digital bone augmentation techniques: a randomised controlled trial

Efficacy of customized bone block versus autologous bone block in the treatment of bone defects: a randomised controlled trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032642
Enrollment
Unknown
Registered
2020-05-04
Start date
2020-05-06
Completion date
Unknown
Last updated
2020-05-11

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

Conditions

Bone defect

Interventions

Experimental group:Customized bone block grafts
Control group:Autogenous bone block grafts

Sponsors

West China Hospital of Stomatology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1) Male or female patients aged 18 to 60 years (including 18 and 60 years); 2) More than 3 months after tooth extraction; 3) One-wall horizontal bone defect or vertical bone defect; 4) Subjects are fully aware of the benefits and risks of this trial and are willing to participate and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1) Heart disease (heart function disease of grade II and above); Abnormal liver and kidney function (ALT and AST > 1.5 times the upper limit of normal value; patients with diabetes, poor control of blood glucose level (fasting blood glucose is still >= 8.0mmol /L after control); 2) Patients with uncontrolled oral diseases, such as progressive periodontal disease, severe periapical infection, and severe habitual molar disease; 3) Uncontrolled metabolic diseases such as diabetes, rickets, thyroid disease, and severe liver and kidney dysfunction. 4) Patients with osteoporosis, osteomalacia and osteosclerosis; 5) Malignant tumors, active infectious lesions, and bone defects in the active phase of metabolic bone disease; 6) Systemic infection or local acute infection of the surgical site; 7) Aplastic anemia and other blood diseases, taking anticoagulant drugs or coagulation tests for 3 months is not within the normal range; 8) The use of drugs that may affect the healing of hard and soft tissues, such as long-term use of sedative hypnotics (continuous use for more than 3 months), long-term use of non-steroidal anti-inflammatory drugs or adrenal corticosteroids (continuous use for more than 3 months), and the treatment of patients who have received drugs in the current or recent 3 months that may affect or promote bone metabolism; 9) Patients with severe smoking (smoking more than 20 cigarettes/day) in the past 6 months and during bone healing; 10) Autoimmune diseases; 11) Radiation therapy is under way; 12) Mental illness, drug abuse and alcohol abuse; 13) Known allergic to the materials used in the product; 14) Women in pregnancy or lactation.

Design outcomes

Primary

MeasureTime frame
Bone thickness;

Secondary

MeasureTime frame
Soft tissue contour;Bone healing of bone graft materials;Operating time;Postoperative pain;Wound Healing;

Countries

China

Contacts

Public ContactMo Anchun

West China Hospital of Stomatology

1369615870@qq.com+86 13808062689

Outcome results

None listed

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