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临床试验/NCT04861662
NCT04861662已完成不适用

Clinical and Radiographic Evaluation of the Effect of Keratinized Mucosa on Peri-implant Health

Kutahya Health Sciences University1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2018年10月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
31
试验地点
1
主要终点
Marginal bone loss

研究概览

简要总结

The aim of this clinical study is to evaluate the significance of keratinized mucosa and to investigate the influence of free gingival graft procedure on peri-implant health status in patients after prothesis delivery.

详细描述

The study will be conducted in Faculty of Dentistry, Kutahya Health Sciences University . The patients who applied to the Department of Periodontology, received dental implant treatment, and required routine follow-up for the maintenance of peri-implant health will be included. Clinical and radiographic examinations will be performed at baseline (prothesis delivery) and at the end of the 3rd, 6th month, 1st year following the prosthetic loading. During clinical examination probing depth (PD), modified plaque index (mPI) and modified bleeding index (mBI) measurements will be evaluated with the Williams periodontal probe. These measurements will be taken at four points of the implant (mid-buccal, mesio-buccal, disto-buccal and mid-lingual) and these four measurements will be averaged for each implant. In addition, the amount of keratinized mucosa (KM) in the implant sites will be evaluated by measuring the mucosal margin and mucogingival junction on the vestibular surface with the same probe. After clinical examination, a periapical radiograph will be taken using a parallel technique to determine marginal bone loss surrounding the implant. The distance between the implant neck and the most coronal part of the alveolar crest will be measured on the mesial and distal surfaces for each implant on the obtained radiographs and the average of the two measurements will be taken. The parameters checked during clinical and radiographic examination will be compared between patients with or without keratinized mucosa and whose keratinized mucosa has been increased by free gingival graft.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being over the age of 18
  • Having dental implant treatment and prosthetic restoration
  • Not having received bone augmentation treatment at the implant site
  • To comply with maintenance controls after dental implant treatment

排除标准

  • Pregnancy
  • Having used systemic antibiotics within 6 weeks prior to the start of the study
  • Having a disease that affects bone and soft tissue metabolism, such as hyperthyroidism, hyperparathyroidism, and uncontrolled diabetes mellitus
  • Using drugs that cause immunosuppression
  • Using a medicine that affects bone metabolism, such as a bisphosphonate

结局指标

主要结局

Marginal bone loss

时间窗: Baseline, 3rd month, 6th month and 1st year

Change of marginal bone loss measured from periapical radiographs

次要结局

  • Modified bleeding index(Baseline, 3rd month, 6th month and 1st year)
  • Probing depth(Baseline, 3rd month, 6th month and 1st year)
  • Modified plaque index(Baseline, 3rd month, 6th month and 1st year)

研究者

发起方
Kutahya Health Sciences University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ezgi Gürbüz

Asst. Prof. Ezgi GÜRBÜZ, DDS

Kutahya Health Sciences University

研究点 (1)

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Effect of Keratinized Mucosa on Peri-implant Health | 临床试验