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临床试验/NCT05162885
NCT05162885Unknown1 期

Effect of Sodium Alendronate Versus Sticky Bone as Socket Preservation Materials on the Final Implant Stability. A Randomized Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2021年5月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
入组人数
24
试验地点
1
主要终点
Implant stability

研究概览

简要总结

evaluation of the final implant stability after its placement in sockets preserved with two different socket preservation materials

详细描述

compare the stability of implant placement using Osstell ISQ "resonance frequency analyzer", and marginal bone resorption and bone density around implant by X-ray analysis in different socket preservation techniques comparing sodium alendronate with the sticky bone graft technique

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 (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • •Patients with seeking implant drive prosthesis after socket has been preserved by either technique.
  • •Patients with seeking implant drive prosthesis with Salama Class 3 defective sockets.
  • •Both genders males and females will be included.

排除标准

  • •General contraindications to implant surgery.
  • •Patient seeking immediate implant placement.
  • •Subjected to irradiation in the head and neck area less than 1 year before implantation.
  • •Untreated periodontitis.
  • •Poor oral hygiene and motivation.
  • •Uncontrolled diabetes.
  • •Pregnant or nursing.
  • •Substance abuse.
  • •Psychiatric problems or unrealistic expectations.
  • •Severe bruxism or clenching.
  • •Immunosuppressed or immunocompromised.
  • •Treated or under treatment with intravenous amino-bisphosphonates.
  • •Active infection or severe inflammation in the area intended for implant placement.
  • •Unable to open mouth sufficiently to accommodate the surgical tooling.
  • •Patients participating in other studies, if the present protocol could not be properly
  • •followed. Referred only for implant placement or unable to attend a 5-year follow-up

研究组 & 干预措施

implant placement in defective Sockets preserved with alendronic acid sponge

Active Comparator

anesthesia according the site of implant placement were administered using mepivacaine HCl (2%) with levonordefrin 1:20 000 (Scandonest 2%; Septodont, Saint- Maur-des-Fossés, France). Injection to control pain and bleeding for hemostasis. Crestal incision with a full thickness mucoperiosteal flap was reflected .A pilot drill will be used to start the osteotomy preparation, then different drilling sizes will be used to attain the final drill size and the planed implant height and width according to Cone Beam CT. Implants were screwed directly into the osteotomy site, primarily the screwing was done mechanically by Fixture Mount Connection attached to the implant carrier.

The created gap sutured passively to allow tension-free interrupted closure using 3-0 coated undyed braided polyglactin 910 suture material.

干预措施: Socket Preservation technique (Procedure)

Implant placement in Defective sockets preserved with sticky bone

Active Comparator

anesthesia according the site of implant placement were administered using mepivacaine HCl (2%) with levonordefrin 1:20 000 (Scandonest 2%; Septodont, Saint- Maur-des-Fossés, France). Injection to control pain and bleeding for hemostasis. Crestal incision with a full thickness mucoperiosteal flap was reflected .A pilot drill will be used to start the osteotomy preparation, then different drilling sizes will be used to attain the final drill size and the planed implant height and width according to Cone Beam CT. Implants were screwed directly into the osteotomy site, primarily the screwing was done mechanically by Fixture Mount Connection attached to the implant carrier.

The created gap sutured passively to allow tension-free interrupted closure using 3-0 coated undyed braided polyglactin 910 suture material.

干预措施: Socket Preservation technique (Procedure)

结局指标

主要结局

Implant stability

时间窗: 3-4 months after Dental implant placement

Calculate the final implant stability of two groups using Osstell "resonance frequency analyzer"

次要结局

  • marginal bone(3-4 months after Dental implant placement)

研究者

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

Hossam Abdallah Mohammed Ghazzaly

H.Ghazzaly

Cairo University

研究点 (1)

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