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Evaluation of the effect of APRF on bone augmentation during hydraulic maxillary sinus floor elevation

Compare the effect of APRF and Bio-oss as sole graft material on bone augmentation during hydraulic maxillary sinus floor elevation: a randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042060
Enrollment
Unknown
Registered
2021-01-13
Start date
2021-01-01
Completion date
Unknown
Last updated
2021-04-12

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

Conditions

Dentition defect

Interventions

Experimental group:put APRF only

Sponsors

West China Hospital of Stomatology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Aged between 18 and 65 years old (including 18 years old and 65 years old), regardless of gender; 2) The maxillary posterior teeth are missing, and the sinus crest distance RBH is 5~8mm; 3) The patient is in good health and can tolerate the operation; 4) Subjects fully understand the benefits and risks of this trial, and are willing to participate and sign 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
residual bone height;sinus floor elevation height;

Secondary

MeasureTime frame
Incidence of maxillary sinus mucosal perforation;Implant Stability Quotient;Implant survival rate;

Countries

China

Contacts

Public ContactMo Anchun

West China Hospital of Stomatology

moanchun@qq.com+86 13808062689

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026