Investigation of biomarker of alveolar bone marrow stem cell (ABMSC) for osseointegration and bone remodeling around implant fixture
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 50
研究概览
简要总结
(1)Information on the subject · Target number of study subjects : 50 · Number of subjects in the observation group : 37 · Number of subjects who completed the research procedure: 31 (98 implants) · Number of subjects to be dropped out : 6 · Presence or absence of serious adverse events, including serious adverse events during the study : none · Number of subjects by sex / age Age (years) Sex Total Male Female 2130 1 1 2 3140 1 1 2 4150 2 5 7 5160 9 1 10 61~ 4 6 10 Total 17 14 31 (2) Information on research outcomes 1) Primary Outcome a) Analysis of Stem cell characteristics of alveolar bone stem cells The stem cell biomarkers used for the Real-time PCR analysis are as follows. (1)Osteogenesis (OC,OPG,ALPL,Runx-2,BMP-2,BSP,Osteopontin) (2)Osteoclastogenesis (RANKL,ICAM-1,M-CSF,IL-1,IL-7) (3)Adipogenesis (LPL,FABP4,PPAR?-2) (4)Tissue healing (VEGF,TGF-ß,HGF,SDF-1,EGF,IL-6) (5)House keeping (GAPDH) b) Short-term clinical and radiographic evaluation of osseointegration and bone remodeling of dental implants None of the implants failed among patients evaluated over the entire study period, representing a 100% survival rate. The peri-implant bone loss (n=98) was 0.04±0.13 mm at the 3-month follow-up and 0.30±0.61 mm at the 1-year follow-up. c) Correlation between Stem Cell Biomarker and Clinical stability of dental implants There were statistically significant differences in the runt-related transcription factor-2 (Runx-2) and bone morphogenetic protein-2 (BMP-2) osteogenesis-related genes, and in the peroxisome proliferator-activated receptor gamma-2 (PPAR?-2) adipogenesis-related gene and the receptor activator of nuclear factor ? ligand (RANKL)/osteoprotegerin (OPG) ratio between the groups with and without marginal bone loss. 2) Secondary Outcome a) Patient-related factors (Age, Sex, Involved jaw, Implant position, Bone quality) b) Implant- or prosthesis-related factors (Implant diameter, Implant length, Insertion torque, Initial ISQ, Implant placement depth, GBR procedure, Type of suprastructure) Variable type Variable No. of implants Implants with peri-implant bone loss Host-related Age (years) =60 63 4 (6.35%) >60 35 5 (14.29%) Sex Male 53 4 (7.55%) Female 45 5 (11.11%) Involved jaw Mandible 41 1 (2.44%) Maxilla 57 8 (14.04%) Implant location Posterior 82 4 (4.88%) Anterior 16 5 (31.25%) Bone quality D2 41 4 (9.76%) D3 39 1 (2.56%) D4 18 4 (22.22%) Implant- or prosthesis-related Implant diameter Narrow 3 1 (33.33%) Regular 95 8 (17.22%) Implant length Short 35 1 (2.86%) Long 63 8 (12.70%) Insertion torque (N) >20 85 9 (10.59%) =20 13 0 (0%) Initial ISQ =70 75 8 (10.67%) <70 23 1 (4.35%) Implant placement depth Crestal 27 4 (14.81%) Subcrestal 71 5 (7.04%) GBR procedure No 81 7 (8.64%) Yes 17 2 (11.76%) Type of suprastructure SC 53 0 (0%) FPD 29 1 (3.45%) OD 16 8 (50.00%)
研究设计
- 研究类型
- Observational Study
入排标准
- 年龄范围
- 18(Year) 至 o Limit(—)
- 性别
- All
入选标准
- •1. Patient who needs implant treatment due to tooth loss
- •2. Patients who do not require bone grafting becaus of sufficient bone
排除标准
- •1. Pregnant woman
- •2. Patients with systemic diseases such as uncontrolled hypertension and diabetes
- •3. Drugs that can cause systemic effects (nifedipin, phenytoin, cyclosporine)
- •4. Smoking (former smoker excluded for more than 10 years) and other systemic diseases
