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临床试验/NCT03540316
NCT03540316Unknown不适用

Treatment Outcome of Short Implant Assisted Mandibular Overdenture in Combination With Low Level Laser Therapy

Sara Zayed1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2018年5月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
12
试验地点
1
主要终点
Assessment of changes in implant stability (Implant Stability Quotient).

研究概览

简要总结

This study evaluates the use of short dental implants to support mandibular overdenture together with the use of laser therapy for treatment of patients with atrophic ridges. All participants will receive laser therapy; half of participants will receive two short implants and the other half will receive four short implants.

详细描述

The conventional solution to complete edentulism is the use of complete removable dentures. One negative effect of edentulism is resorption of the edentulous ridge over time. Construction of a successful mandibular complete denture for patients with advanced mandibular ridge resorption is often difficult and on some occasions virtually impossible. It has been proved that when implants are placed, bone gets stimulated resulting in minimal bone loss. But anatomic limitations to implant placement have been observed in atrophic ridges, so short implants introduced as a recent alternative to aggressive surgical procedures proposed to compensate for tissue deficiency. Also, Low Level Laser Therapy (LLLT) has proven success in improving implant stability which is very crucial in short implants. Thus, the purpose of this study is to evaluate and compare the treatment outcome of mandibular overdenture assisted by two short implants versus that assisted by four short implants in combination with LLLT.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

入排标准

年龄范围
45 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Completely edentulous patients.
  • Patients with mandibular resorbed edentulous ridge.
  • Medically fit patients with no systemic conditions.
  • Class I ridge relation.
  • Adequate zone of keratinized mucosa.

排除标准

  • Metabolic bone disease or unstable systemic condition.
  • Heavy smokers.
  • A history of radiotherapy in the head and neck region.
  • Physical or mental disability.
  • Temporomandibular and neuromuscular disorders.

结局指标

主要结局

Assessment of changes in implant stability (Implant Stability Quotient).

时间窗: Baseline, 6 months &12 months.

Implant stability can be defined as the absence of clinical mobility. It will be assessed at the time of implant placement (baseline) ,then six months and twelve months later, by the resonance frequency analysis using Osstel devise which measure implant oscillation frequency on the bone;Implant Stability Quotient (ISQ) .

次要结局

  • Peri-implant marginal bone changes.(Baseline, 6 months &12 months.)
  • Assessment of changes in peri-implant probing depth .(Baseline, 6 months &12 months.)
  • Assessment of changes in modified gingival index(Baseline, 6 months &12 months.)

研究者

发起方
Sara Zayed
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sara Zayed

Director

Alexandria University

研究点 (1)

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