跳至主要内容
临床试验/DRKS00031628
DRKS00031628进行中(未招募)4 期

Clinical application of a porcine hydroxyapatite (The Graft) and an alloplastic ß-Tricalciumphosphate (Osopia) in comparison to a bovine hydroxyapatite (BioOss) for maxillary sinus augmentation: a radiological and histological analysis - Maxillary sinus augmentation using porcine, bovine and alloplastic BSM

Mund-, Kiefer- und Gesichtschirurgische Klinik des Universitätsklinikums Erlangen0 个研究点目标入组 29 人开始时间: 2023年4月6日最近更新:
适应症

试验速览

阶段
4 期
状态
进行中(未招募)
发起方
入组人数
29

研究概览

简要总结

Histological analysis: DPBM acts as an osteoconductive bone substitute material with a rate for newly formed bone comparable to DBBM 4 months after maxillary sinus augmentation. Within the testing groups microstructured BCP showed a higher proportion of NFB, whereby compared to the control and testing groups no statistaical significant differences exists. Radiological analysis: Concerning bone graft stability/ volume DBBM and DPBM show comparable outcomes. Due to resorption, BCP showed inferior bone graft volume after healing (statistically significant) compared to DBBM and DPBM.

研究设计

研究类型
Interventional
分配方式
Randomized controlled study
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 one(—)
性别
All

入选标准

  • edentulous upper jaw or residual dentition in the upper jaw posterior region
  • - insufficient bone supply in height and width
  • - remaining bone height in the maxillary alveolar crest between 4 and 6 mm

排除标准

  • - Acute infections
  • - Acute sinusitis
  • - Radiotherapy in the head and/or neck area
  • - Chemotherapy
  • - Poor oral hygiene or motivation
  • - Active periodontitis
  • - Pregnancy
  • - Drug or alcohol abuse
  • - Smoker (>10 p.d.)
  • - Hematological diseases
  • -Metabolic
  • - Uncontrolled or treatment-resistant diabetes
  • - Autoimmune diseases
  • - Immunological diseases
  • - Chronic osteopathies
  • - Antiresorptive medication (bisphosphonates, anti-RANKL antibodies, anti-VEGF antibodies, tyrosine kinase inhibitor, mTOR inhibitor)
  • - Steroid medication
  • - Untreated carious lesions of neighboring teeth
  • - Untreated endodontic lesions of neighboring teeth
  • - Limited mental abilities and language skills, so that study information and instructions cannot be understood

研究者

发起方
Mund-, Kiefer- und Gesichtschirurgische Klinik des Universitätsklinikums Erlangen

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