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临床试验/NCT04930835
NCT04930835已完成不适用

Treatment Outcomes With Full Arch Rehabilitations Supported by Immediate or Conventionally Loaded Implants: A Randomized Clinical Trial

University of Salamanca2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年1月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Oral health-related quality of life

研究概览

简要总结

This study aims to assess the treatment outcomes (clinical, functional and subjective) of full arch rehabilitations supported by implants with or without an immediate loading protocol. In this randomized clinical trial 20 fully edentulous patients were treated with full arch rehabilitations on dental implants. In half of the sample, the implants were loaded immediately by means of abutments after emplacement of the implant; but in the counterparts these abutments were connected to implants two months after the surgery (conventional protocol), and until that time the dentures were retained by healing abutments. Treatment outcomes were assessed at 2, 6 and 12 months after surgery. Clinical outcomes were quantified on the basis of implant failure rate, marginal bone loss and the peri-implant gingival index. Functional outcomes were calculated according to masticatory performance, estimated by the mixed fraction of a two-coloured chewing gum after 5, 10 and 15 chewing strokes, by the occlusal force recorded by pressure-sensitive sheets and by the bioelectrical muscular activity. The subjective outcomes of the treatment were assessed using both the oral satisfaction scale (visual analogue scale) and the Spanish version of the Oral Health Impact Profile (OHIP-20).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

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

  • completely edentulous individuals who had lacked teeth for more than 10 years, routine users of conventional complete prostheses.
  • sufficient amount of remaining bone to receive the implants in the region of the mandibular canines (minimum height=15 mm/minimum ridge width= 5mm)
  • no evidence of systemic or psychic pathology that might contraindicate the implant treatment.

排除标准

  • Those in which oral surgery or cognitive evaluations are contraindicated

结局指标

主要结局

Oral health-related quality of life

时间窗: One year after treatment

impact according to the OHIP-20 (Oral Health Impact Profile) instrument. The score range from 0 to 20, being 20 the worst outcome.

Area of Occlusal Occlusion

时间窗: One year after treatment

According to pressure-sensitive colorimetric sheets it is recorded the area in square millimeters

Clinical Performance of Dental implants

时间窗: One year after treatment

Implant failure rate

Mastication

时间窗: One year after treatment

Mixing ability tests

Occlusal Load

时间窗: One year after treatment

According to the pressure-sensitive colorimetric sheets , the load in both the anterior and posterior region of the arch are calculated.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

JAVIER MONTERO

Full professor in Prosthodontics at the University of Salamanca

University of Salamanca

研究点 (2)

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