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临床试验/NCT03804177
NCT03804177Unknown4 期

The Effect Of Hyaluronic Acid And Melatonin With Systemic Administration of Vitamin C On Implant Stability After Immediate Implant Placement in Anterior and Premolar Region in Systemically Healthy Patients

Cairo University0 个研究点目标入组 24 人开始时间: 2019年2月10日最近更新:
适应症
干预措施

试验速览

阶段
4 期
入组人数
24
主要终点
implant stability

研究概览

简要总结

The concept of immediate implant placement at the time of tooth extraction was first introduced by Schulte et al. on animal studies. Since then, many follow-up studies examining different variables have supported the concept of immediate implant placement. pioneered a major contribution to immediate implant placement in human studies which recommended the insertion of an implant into a fresh extraction socket.

They advocated immediate implant placement primarily to reduce the number of surgical interventions needed to perform an implant-supported rehabilitation and shorten the treatment time.

Placement of implants immediately into extraction sites allow the surgeon to idealize the position of the implant appropriately with a better rehabilitation of the normal contour to the facial aspect of the final restoration.

Immediate implant placement in fresh extraction sockets was reported to reduce alveolar bone resorption. Better esthetic outcomes were achieved including the prosthetic crown length in harmony with the adjacent teeth, natural scalloping and easier distinct papillae to achieve and maximum soft tissue support.

Hyaluronic acid is a glycosaminoglycan, this unique molecule is implicated In a variety of biological functions including structural integrity, and the regulation of embryologic development. It is described as a natural organic substance, with physiological therapy activity, main component of the extracellular matrix of many tissues such as the skin, synovial joints and periodontal tissues .

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
Double (Participant, Outcomes Assessor)

盲法说明

single blinded

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

  • Systemically healthy patients indicated for single or multiple immediate implants in anterior and premolar region.
  • Absence of any peri-apical pathosis.
  • Patients with intact buccal plate of bone.
  • Patients with adequate bone volume for the dental implant procedure.
  • Patient consent approval and signing.

排除标准

  • Systemic disease that may affect the final outcome of the surgical procedure.
  • No or poor patient's compliance.
  • Patients with psychological problems.
  • Pathology at the site of intervention.
  • Pregnant patients.
  • Patients refuse to sign an informed consent.

研究组 & 干预措施

implant with hyaluronic melatonin vit c

Experimental

implant placement with topical application of hyaluronic and melatonin and systemic administration of vitamin C

干预措施: immediate implant placement with melatonin hyaluronic acid vit C (Procedure)

immediate implant

Active Comparator

immediate implant placement alone without melatonin or hyauronic acid nor vitamin c

干预措施: immediate implant placement without melatonin hyaluronic acid vit C (Procedure)

结局指标

主要结局

implant stability

时间窗: 6 months

implant stability by ostell

次要结局

  • soft tissue healing(6 months)

研究者

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

Ahmed Nabil Abdelfatiah

assistant lecturer

Cairo University

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