Osteogenic effects of concentrated growth factors applied in maxillary sinus floor elevation via a lateral window approach with simultaneous implant placement:study protocol for a single-center randomized controlled trial
10.3969/j.issn.2095-4344.2017.04.014
- VernacularTitle:浓缩生长因子在上颌窦侧壁开窗窦底提升即刻种植中的成骨效果：单中心、随机对照临床试验方案
- Author:
Yang CHENG
;
Min LIU
- From:
Chinese Journal of Tissue Engineering Research
2017;21(4):574-579
- CountryChina
- Language:Chinese
-
Abstract:
BACKGROUND:Maxil ary sinus floor elevation via a lateral window approach is the most effective method of overcoming the shortage of bone mass deficiency in atrophic maxil ary posterior region. Bone transplantation is considered to be a prerequisite for the success of maxil ary sinus floor elevation. Platelet-rich plasma and platelet-rich fibrin have been used to accelerate bone formation, regeneration, and repair. However, few in-depth studies are reported on the effects of concentrated growth factors on new bone formation. OBJECTIVE:To investigate the effects of concentrated growth factors applied in maxil ary sinus floor elevation via a lateral window approach with simultaneous implant placement on repair of bone defects and new bone formation. METHODS:This was a randomized double-blind control ed trial, which was performed at the Hospital of Stomatology, Southwest Medical University, China. Forty patients presenting with loss of maxil ary molars and residual bone height of 2-5 mm in the posterior maxil ary region were included in this study. These patients were randomly assigned to either receive concentrated growth factors, hydroxyapatite and autogenous bone (experimental group, n=20) or hydroxyapatite and autogenous bone (control group, n=20) at bone defect sites. X-ray examination was performed 1, 3 and 6 months after surgery to evaluate bone regeneration and repair as per excel ent and good rate. The thickness of the cortical bone at the defect sites was measured using a dental cone beam CT scanner to reflect bone density. The study protocol had been approved by Ethics Committee of Hospital of Stomatology, Southwest Medical University, China, was performed in strict accordance with the Declaration of Helsinki, and had been registered with ClinicalTrial.gov (identifier NCT03046173). Written informed consent had been obtained from each patient prior to enrol ment. RESULTS AND CONCLUSION:This study was completed in 2016. Study outcomes were obtained as fol ows:X-ray images showed that 3 and 6 months after surgery, bone regeneration around the implant was better in the experimental group than in the control group (P<0.01) and better bone regeneration in the experimental group was observed at 6 months than at 3 months after surgery. At 1, 3 and 6 months after surgery, bone density at bone defect site was significantly greater in the experimental group than in the control group (P<0.01). These results suggest that concentrated growth factors applied in maxil ary sinus floor elevation via a lateral window approach with simultaneous implant placement can promote new bone formation and accelerate synosteosis.
