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临床试验/NCT04678674
NCT04678674Unknown不适用

Autogenous Tooth Roots for Lateral Alveolar Ridge Augmentation and Staged Implant Placement

St. Catherine Specialty Hospital2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年1月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
2
主要终点
The primary endpoint was defined as the clinical width (CW) of the alveolar ridge

研究概览

简要总结

A deficient alveolar ridge segment in prepara¬tion for implant placement can be regenerated by several techniques. The type of graft material for each patient depends on many factors such as the anatomy, the morphology of the bone defect, type of prosthodontic rehabilitation and patient or clinician preferences. Bone graft material should have three properties that made it ideal: a) osteoconduction, it provides scaffolds for bone regeneration; b) osteoinduction, it promotes the recruitment of bone-forming cells and formation of bone and c) osteogenesis, induction of cells in the graft to promote regeneration of the bone.

Despite of the development of different types of graft material, autogenous bone is still the gold standard for bone augmentation because it exhibits these three mentioned properties. Although it has many advantages, autologous bone has some disadvantages such as high resorption rate up to 50 %, limited source and donor site morbidity. Allografts, xenografts and alloplastic bone graft are materials that are used in everyday practice and over long period, but their disadvantages are numerous in comparison with autologous bone. Allografts can be carrier of some disease and show lack of osteoproliferation, while alloplasts and xenografts show only osteoconduction. According to these facts, it is obvious that there is a need for development an alternative graft material that will surpass these disadvantages.The reconstruction of deficient alveolar ridge defect by the lateral bone augmentation prior to the dental implant placement is predictable and commonly used method. Except animal studies, recent clinical studies showed that there is no difference in the osseointegration of titanium implants in deficient alveolar ridges reconstructed with autogenous cortical bone blocks or autogenous teeth.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • age 18 to 60 years
  • candidate for lateral ridge augmentation
  • insufficient bone ridge width at the recipient site for implant placement
  • sufficient bone height at the recipient site for implant placement and (e)
  • healthy oral mucosa
  • at least 2 mm keratinized tissue

排除标准

  • general contraindications for dental and/or surgical treatments
  • inflammatory and autoimmune disease of the oral cavity,
  • uncontrolled diabetes (HbA1c > 7%)
  • history of chemotherapy or radiotherapy within the past five years,
  • previous immunosuppressant, bisphosphonate or high- dose corticosteroid therapy
  • pregnant or lactating women

结局指标

主要结局

The primary endpoint was defined as the clinical width (CW) of the alveolar ridge

时间窗: 6 months

The primary endpoint was defined as the clinical width (CW) of the alveolar ridge being sufficient for the placement of an adequately dimensioned dental implant without the need for a secondary grafting at 6 months after surgery in either group. CW was assessed before (CWa) and after (CWb) augmentation healing period of 6 months in cone-beam computed tomography (CBCT) scans. Measurements were performed to the nearest 0.5mm below the crest using a CBCT.

次要结局

  • soft tissue dehiscences(6 months)
  • gain in ridge width (CWg)(6 months)
  • wound infections(6 months)
  • Periimplant tissue stability of augmented sites after prosthetic rehabilitation(12 months)

研究者

发起方
St. Catherine Specialty Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Igor Smojver

Principal Investigator

St. Catherine Specialty Hospital

研究点 (2)

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