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Autologous versus Allogeneic Cortical Lamina for Circular Cortical-lamina Anchoring Technique:A prospective randomized controlled clinical trial study

Autologous versus Allogeneic Cortical Lamina for Circular Cortical-lamina Anchoring Technique:A prospective randomized controlled clinical trial study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087803
Enrollment
Unknown
Registered
2024-08-05
Start date
2024-08-15
Completion date
Unknown
Last updated
2024-08-12

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

Conditions

Atrophic Alveolar Ridge

Interventions

Homogeneous Circular Cortical-lamina Anchoring group:circular cortical-lamina anchoring technique was applied with homogeneous circular cortical lamina
Autologous Circular Cortical -lamina Anchoring group:circular cortical-lamina anchoring technique was applied with autologous circular cortical lamina

Sponsors

Stomatological Hospital, School of Stomatology, Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Voluntarily sign informed consent; Mandibular dentition defect with at least one tooth position and does not require a second operative area during the surgical procedure ; According to Cawood and Howell classification, patients diagnosed with Class IV bone defect (i.e. knife-edge alveolar ridge with insufficient horizontal bone width and sufficient vertical bone height ) had a bone width < 4 mm at 1 mm below the alveolar ridge. Systemically healthy patients (American Society of Anesthesiologists - ASA Class I and II: mild complications other than surgical disease, functional compensation is sound); The patient was more than 18 years old at the time of the first operation and had good medical compliance. The periodontal status was in the periodontal maintenance period (plaque index < 20%, probing bleeding score < 10%); Implant surgery was chosen for treatment

Exclusion criteria

Exclusion criteria: Patients with contraindications for routine implant surgery or uncontrollable systemic diseases; 1) Severe systemic diseases: a. Hypertension, with systolic blood pressure (high pressure) > 150 mmHg or diastolic blood pressure (low pressure) > 90 mmHg. b. Uncontrolled diabetes: fasting blood sugar = 7.0 mmol/L or glycated hemoglobin (HbA1c > 7%). c. Heart disease (class 3-4 heart function), or symptoms such as orthopnea, lower limb edema. d. Cardiopulmonary disease, heart failure patients. e. Cerebrovascular and cardiovascular diseases (In the past six months, angina pectoris, myocardial infarction, cerebral infarction occurred. Recent episodes of angina pectoris are frequent). f. Third-degree or second-degree type II atrioventricular block, bifascicular block, Adams-Stokes syndrome. g. Heart valve disease. h. Acute hepatitis (which can cause severe liver damage). i. Severe asthma, severe pharyngitis, severe depression. j. Severe hyperthyroidism: pulse > 100 beats per minute, basal metabolic rate > 20%. k. Hematological diseases: hemophilia, leukemia, and other bleeding disorders, or coagulation disorders due to anticoagulant medication, INR > 3 or clinically significant abnormalities in coagulation panel. 2) Long-term use of the following medications: a. Intravenous and high-dose oral bisphosphonates for the prevention of bone metastasis and treatment of osteoporosis. b. Avascular necrosis of the joint due to the use of steroidal drugs (typical cases: SARS patients). c. Long-term treatment with adrenal corticosteroids. 3) Patients with AIDS, syphilis, and drug abusers. 4) Patients with other systemic diseases that make them unable to tolerate surgery. 5) Pathological changes in the alveolar bone. Acute or severe infection accompanied by a white blood cell count > 10×10^9/L. Maxillary sinus effusion greater than one-third. Abnormal occlusal relationships or bad occlusal habits around the edentulous area that may lead to traumatic resorption of bone around the implant and cause surgical failure; oral mucosal lesions; severe soft tissue lesions in the edentulous area; limited mouth opening; History of drug allergy: severe allergic reactions to anesthetics, anti-inflammatory and analgesics, and other medications used during and after surgery. Pregnant, menstruating, or lactating women. Uncontrolled periodontal disease or poor oral hygiene habits that cannot be improved (probing depth > 4mm, BOP > 10%). Need for a second surgical area for bone augmentation surgery. Heavy smokers (> 10 cigarettes per day). Patients with bone metabolic diseases: currently taking medications that may affect bone metabolism. History of malignant tumors, within 5 years of radiotherapy or chemotherapy for malignant tumors. The researcher considers other reasons not suitable for participating in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Alveolar ridge width;

Secondary

MeasureTime frame
Implant success rate;Operation duration;Postoperative adverse reactions and complications;marginal bone loss;

Countries

China

Contacts

Public ContactGuo Zehong

Stomatological Hospital, School of Stomatology, Southern Medical University

36648547@qq.com+86 137 2809 8343

Outcome results

None listed

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