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临床试验/NCT02836964
NCT02836964撤回不适用

Early Loading of Dental Implants: A Prospective Study in the Mandibular First

Loma Linda University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2017年2月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
入组人数
24
试验地点
1
主要终点
Assessment of marginal bone level changes

研究概览

简要总结

This study will compare tissue healing outcome between early dental implant loading at 4 weeks and conventional dental implant loading at 3 months.

详细描述

Both loading times are standard of care procedures. The rationale behind early loading is to reduce waiting time so dental implants can be utilized sooner.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • Patients aged 18 years or older.
  • Willingness to comply with all study requirements.
  • Partially edentulous in the in mandibular first molar with presence of the mandibular second molar
  • Patients of ASA I and ASA II group. No relevant medical conditions such as uncontrolled diabetes mellitus, osteoporosis, malignancies, irradiation and blood dyscrasias.
  • Free from soft tissue mucosal lesions, caries, and active periodontitis at the time of implant insertion.
  • Sufficient alveolar bone volume at the implant recipient site at the time of the insertion.
  • Adequate oral hygiene. Full-mouth plaque score (FMPS) (O'Leary et al. 1972) full-mouth bleeding score (FMBS) (Ainamo & Bay 1975) record as the percentage of surfaces, four per each tooth, patients need to have controlled their periodontal conditions (FMPS 20%, FMBS 20%).

排除标准

  • Pregnant or lactating females.
  • Systemic disease likely to compromise implant surgery; uncontrolled diabetes mellitus.
  • History of irradiation in the head and neck area.
  • Untreated periodontitis.
  • Alcohol or drug abuse.
  • History of Intravenous Bisphosphonate.
  • Previously augmented or tooth extraction at the intended implant recipient site within the last 6 months.
  • The use of regenerative procedures in conjunction with implant placement.
  • Presence of residual roots at the implant recipient site.
  • Stomatological diseases.
  • Clinical signs of bruxism.
  • Initial stability at least 30Ncm

结局指标

主要结局

Assessment of marginal bone level changes

时间窗: Change between Implant Placement Visit and Final evaluation Visit at 6 months post dental implant

Standardized intraoral radiograph will be used to measure the distance between the implant platform and the marginal bone

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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