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临床试验/NCT06031168
NCT06031168尚未招募不适用

Evaluation the Effect of Topically Coated Dental Implants With 1% Metformin Gel on Osteointegration and Crestal Marginal Bone Loss (a Randomized Controlled Clinical Trial)

Hams Hamed Abdelrahman1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2023年9月4日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
26
试验地点
1
主要终点
Change in implant stability

研究概览

简要总结

Achieving and maintaining a long term osseointegrated dental implant is a golden goal of success in field of dentistry. Osteointegration depends on surface treatment of dental implants. various techniques of implant coating have been introduced to enhance and accelerate osteointegration. The purpose of present study is to clinically and radiographically evaluate the osseointegration around hydrophilic dental implants coated with 1% Metformin gel Materials and Methods: We executed a randomized controlled clinical trial. The sample will include patients demanding dental implant treatment. Patients will be randomly allocated into the two groups of the study. The group A will be treated with 1% concentrated metformin gel coated hydrophilic dental implant. Group B will be treated with uncoated hydrophilic dental implant. The primary outcome variable will be implant osteointegration and crestal marginal bone loss around implants. It will be measured at time of implant placement and reevaluated after 4, 6-months with periapical x-ray and 3-dimensional imaging.

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
Single (Participant)

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Good general periodontal health and maintenance.
  • Adequate amount of bone volume at implant site, allowing to perform the dental implant surgery procedure without bone grafting techniques
  • Exclusion criteria
  • Heavy smokers who smoke more than ten cigarettes per day
  • Diabetic patients who have received metformin as antidiabetic drug
  • local or systemic conditions that will interfere with routine implant placement (uncontrolled diabetes mellitus or human immune deficiency virus infections, resonance therapy), bone disorders (hyperparathyroidism, osteoporosis, or Paget's disease
  • Patients who had subjected to intravenous and/or oral bisphosphonate therapy.

排除标准

  • 未提供

结局指标

主要结局

Change in implant stability

时间窗: Baseline and 4 months

stability will be assessed by using ostell device

次要结局

  • change in marginal bone loss(Baseline and 4 months)

研究者

发起方
Hams Hamed Abdelrahman
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hams Hamed Abdelrahman

Assistant lecturer of DPH and Clinical statistician

Alexandria University

研究点 (1)

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