Jaw defect (or insufficient bone mass)
Conditions
Interventions
Experimental group:Calcium-silicon bio-ceramic bone repair materials
Control group:Bone filling material Geistlich Bio-Oss (Geistlich Pharma AG)
Sponsors
Hospital of Stomatology Wuhan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Patients participating in this clinical trial must meet all the following selection criteria: 1) 18-70 years old (including 18 and 70 years old), regardless of gender; 2) periodontal health, single tooth missing as a reference for adjacent teeth (without metal post-core crown restoration), patients who need implant repair. 3) the alveolar bone mass of the site to be repaired was not enough (except for the simple lingual and palatal bone deficiency), and the patients who needed guided bone tissue regeneration at the same time were implanted. 4) the patients voluntarily participated in the clinical trial and signed the informed consent form.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will not be allowed to participate in this trial: 1) patients with a previous history of alveolar bone preservation in the tested tooth position; 2) patients with bone metabolic diseases (such as osteoporosis, deformed osteitis, etc.). Or patients who have taken drugs or products that significantly affect bone metabolism (such as steroids, diphosphonates, etc.) within one month before admission; 3) patients who are receiving radiotherapy or chemotherapy. 4) patients who need to mix autologous bone or other bone replacement products, and patients who need to be combined with surgical bone increment techniques other than GBR; 5) patients with acute apical periodontitis, progressive periodontitis, history of intractable periodontitis, infection, etc.; 6) patients with poor oral environment and can not maintain good oral hygiene care; 7) patients who cannot carry out oral imaging examination and affect outcome assessment. 8) patients with severe heart disease and abnormal blood coagulation determined by researchers to be unsuitable for surgery; 9) patients with abnormal liver and kidney function (ALT and alt values exceeding 3 times the normal limit, or creatinine exceeding 1.5 times the normal limit); 10) patients with poorly controlled diabetes (fasting blood glucose more than 2 times the normal limit) and hypertension with poor control (systolic blood pressure = 160mmHg and / or diastolic blood pressure = 100mmHg). 11) pregnant and intended pregnant women of childbearing age and lactating women; male patients whose spouses intend to become pregnant; 12) patients who smoke heavily (= 10 cigarettes per day); 13) patients with severe mental illness; 14) patients who have participated or are participating in clinical trials of other drugs or devices in the past 3 months; 15) other patients who have been determined by researchers to be unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of average thickness of alveolar bone on labial and buccal side of implant; | — |
Secondary
| Measure | Time frame |
|---|---|
| Wound healing of gingival tissue in the implanted area; | — |
Countries
China
Contacts
Public ContactYufeng Zhang
Hospital of Stomatology Wuhan university
Outcome results
None listed