A Method for Measuring Volume Changes of the Alveolar Ridge During Dental Implantation Using 3D Scanning
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Extent of bone resorption
研究概览
简要总结
Investigation of the volume stability of the alveolar ridge, the bone structure and soft tissue appearance at a delayed dental implantation using two bone substitute materials (1. Human-Spongiosa, gefriergetrocknet, CHB; 2. collacone®)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
outcome assessors will be masked during the evaluation period. Subjects will be identified through their randomization number. Patients identification log is stored at the study site and only available to the investigator who is responsible of concealment of these information.
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Indication for tooth extraction resulting in a edentulous gap
- •Male and female patients with an age range 20-60 years
- •Caucasian
- •For female patients: a negative pregnancy test
- •Normotonic blood pressure (according to the WHO definition):
- •Men: 110/70 - 140/90 mm Hg
- •Women: 100/60- 140/90mm Hg
排除标准
- •Parallel implantation of another implant
- •Parallel planned prosthetic restoration of the adjacent teeth
- •Smoker (less than 5 years non-smoker)
- •Nursing women
- •Participation in another clinical trial which dates back to less than 3 months before inclusion in this clinical trial
- •Intake of bisphosphonates
- •Radiation therapy (medical history or current)
- •Known Diabetes mellitus
- •Inflammatory processes in the mouth (PSI> 2)
- •Presence of autoimmune diseases (Rheumatoid arthritis, Sjögren's syndrome, Systemic lupus erythematosus)
- •Presence of blood coagulation disorders (Haemophilia A/B), or the intake of anticoagulants (Warfarin, new oral anticoagulants, aspirin> 100 mg)
- •Osteogenesis imperfecta
- •Osteoporosis
- •Agranulocytosis
- •Immunocompromised patients
- •Acute phase and rehabilitation phase of myocardial infarction
- •Oncogenes diseases
- •Patients undergoing chemotherapy
- •Acute and chronic infections: sinusitis, rhinitis, pharyngitis and Otitis media
- •Wound healing disorders
- •Gingival hyperplasia
- •Alcohol abuse
- •Drug abuse
- •Infectious diseases (HIV, Hepatitis B and C)
研究组 & 干预措施
Human-Spongiosa (IMP: drug)
Product Name: Human-Spongiosa,gefriergetrocknet, CHB / Pharmaceutical form: Granules / Routes of Administration: Dental use / Marketing authorisation number : 3004134.00.00 / Marketing Authorisation Holder: Institute of Transfusion Medicine, Tissue bank, Charité university of medicine Berlin / Used by socket preservation
干预措施: Human-Spongiosa (Drug)
collacone® (IMP: medical device)
Product Name: Collacone / Pharmaceutical form: Absorbable, local Hemostat, porcine collagen / Routes of Administration: Dental use / Medical device with a CE mark / Used by socket preservation
干预措施: collacone® (Device)
结局指标
主要结局
Extent of bone resorption
时间窗: According to E9 guideline, the assumptions of the sample size calculation and the statistical analysis plan, which was approved by PEI we include "all relevant time points", respective: T-1 (baseline), T2, T3, T5, T6, T7, T8 (see definition above)
The main objective is to measure the extent of resorption of the alveolar ridge bone following teeth extraction and alveolar management (socket preservation) and to compare the two authorized bone substitute materials: 1. Human Spongiosa, gefriergetrocknet, CHB + mucoderm® and 2. collacone® + mucoderm® through 3D surface scan. Definition of time points: T-1 = baseline T2 = 1 month after extraction T3 = 4.5 months after extraction = time point of implantation T5 = 1 month after implantation T6 = 3 months after implantation T7 = 6 months after implantation T8 = 9 months after implantation
次要结局
- Pink Esthetic Score(T-1 (baseline before teeth extraction), T1 (7-10 days after extraction), T2 (1 month after extraction), T3 (time of implantation; 4.5 months after extraction), T5, T6, T7 and T8 (respective 1, 3, 6 and 9 months after implantation))
- Implants stability(4.5 months after teeth extraction and socket preservation (T3) and 3 months after implantation (T6))
- Histologic bone investigation(4.5 months after teeth extraction and socket preservation (T3))