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A multicenter randomized, open label, positive controlled trial for evaluation of the safety and effectiveness of combined graft in repairing alveolar bone defect

A multicenter randomized, open label, positive controlled trial for evaluation of the safety and effectiveness of combined graft in repairing alveolar bone defect

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023051
Enrollment
Unknown
Registered
2019-05-09
Start date
2017-08-25
Completion date
Unknown
Last updated
2019-05-13

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

Conditions

Alveolar bone defect

Interventions

Experimental group:Implant bone material and membrane
Control group:Implant bone material and membrane

Sponsors

West China Stomatological Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 65 years male or female patients; 2. A single tooth with a reference to the adjacent tooth is required for bone grafting; 3. There is bone defect in the alveolar bone wall, and the vertical height of the bone wall with the largest bone defect is =5mm. It contains: 1) normal tooth extraction; 2) or the third impacted molar needs to be removed, and the distal bone defect of the adjacent tooth exceeds the root of the tooth. Patients with two-thirds or more of the length; 3) or a patient with a single tooth cyst; 4. Patients volunteered to participate in clinical trials, signed informed consent, and were able to cooperate with clinical follow-up.

Exclusion criteria

Exclusion criteria: 1. Participated in other clinical trials within 3 months prior to the start of the trial; 2. Various bone defects caused by invasive and malignant bone tumors; 3. Patients who may have affected or promoted the treatment of bone metabolism medications are being treated in the past 3 months; 4. Active infectious lesions, various bone defects produced during the active period of metabolic bone disease; 5. Patients with severe heart, liver and kidney dysfunction are defined as: Heart function: Level II and above; (1) ALT, AST> 2 times the upper limit of normal value; (2) serum creatinine> upper limit of normal value; 6. Patients with poor control of diabetes (drug-controlled fasting blood glucose is still = 8.0mmol / L); 7. Mental disorders, inactivity and autonomy; 8. Patients with allergic constitution; 9. Pregnant or lactating women and those with a pregnancy plan within six months; 10. Various subjects who can cause artifacts in the oral examination of the operation area, such as metal dentures, porcelain teeth, etc.; 11. The doctor judges other circumstances in which he or she cannot participate in the trial.

Design outcomes

Primary

MeasureTime frame
Combined bone graft after 180 days of imaging changes after alveolar bone defect repair;

Secondary

MeasureTime frame
Whether the test film is damaged or not, whether the filling has overflowed;Evaluation of clinical surgical incision healing;Rejection reaction;the variety of bone metabolism;Post-filling symptoms;The sign of bone infection;

Countries

China

Contacts

Public ContactPan Jian

West China Hospital of Stomatology, Sichuan University

jianpancn@163.com+86 028 85501437

Outcome results

None listed

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