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临床试验/NCT06842368
NCT06842368招募中不适用

Immediate Implant Placement Using Xenograft As Space Filling Material Mixed with Vitamin D Versus Hyaluronic Acid in Posterior Mandible Region: a Randomized Controlled 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: 2025年2月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
24
试验地点
1
主要终点
Implant secondary stability

研究概览

简要总结

Immediate implant placement using xenograft as space filling material mixed with vitamin D versus hyaluronic acid in posterior mandible region This study aims to evaluate implant stability and density after placement of immediate implant and Xenograft mixed with Hyaluronic acid or Vitamin D at posterior mandible region

详细描述

Dental implants in fresh extraction sockets and healed sites have a erratic morphology, creating a wide space defect between the implant and buccal alveolar bone. This defect is critical for implant success, known as a jumping gap. Proper management of this space is essential for esthetic and functional success. Studies show adequate bone fill can be achieved in jumping gaps, but wider gaps increase implant body exposure risk.

The application of biological mediators embedded in the biomaterial can induce specific cell and tissue response, which can improve bone quality and quantity. Dental research has focused on improving bone substitutes by morphologic or bio- chemical modification.

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
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Each patient will be given a code by the researcher and the observers will be blind to which group this case belong. Patients, radiographic outcome assessor and statistician will be blinded.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Systemically healthy patients indicated for single or multiple immediate implants in posterior teeth 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 with good oral hygrine

排除标准

  • •Heavy Smokers.
  • •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.
  • •Patient with vit d deficiency

研究组 & 干预措施

Hyaluronic acid mixed with Xenograft as space filling material after placement of immediate implant.

Active Comparator

Careful extraction of the selected tooth will initiated using sharp periotome to sever the periodontal ligament attachments while preserving the surrounding alveolar bone and interdental papilla and followed by using extraction forceps. Meticulous mechanical debridement of the extraction socket will be carried out using bone curette to remove any soft tissue remnants or granulation tissue. All debris will washed out using copious saline irrigation. Implant osteotomy will then initiated engaging the furcation of the alveolus along with the remaining apical bone and while maintain jumping gap more than 2 mm between the implant platform and the alveolar. the jumping space will packed using Xenograft with particle size ranging from 0.25 to 1 mm and it will be mixed with hyaluronic acid and the socket will sealed using 4-0 resorbable sutures.

干预措施: Hyaluronic Acid (HA) (Procedure)

Vitamin D mixed with Xenograft as space filling material after placement of immediate implant.

Experimental

Careful extraction of the selected tooth will initiated using sharp periotome to sever the periodontal ligament attachments while preserving the surrounding alveolar bone and interdental papilla and followed by using extraction forceps. Meticulous mechanical debridement of the extraction socket will be carried out using bone curette to remove any soft tissue remnants or granulation tissue. All debris will washed out using copious saline irrigation. Implant osteotomy will then initiated engaging the furcation of the alveolus along with the remaining apical bone and while maintain jumping gap more than 2 mm between the implant platform and the alveolar. the jumping space will packed using Xenograft with particle size ranging from 0.25 to 1 mm and it will be mixed with Vitamin D and the socket will sealed using 4-0 resorbable sutures.

干预措施: Vitamin D (Procedure)

结局指标

主要结局

Implant secondary stability

时间窗: after 6 months

To evaluate the implant stability by Any-check device.

次要结局

  • Density of bone around implant(after 6 months)

研究者

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

Ammar Mohamad Adib Eiz Eddin

Master's degree candidate

Cairo University

研究点 (1)

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