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临床试验/NCT05465421
NCT05465421Unknown不适用

Clinical and Radiographic Assessment of Buccolingual Bone Dimension Following Socket Preservation With Bone Marrow Mono-nuclear Cell From the Maxillary Tuberosity Combined With Platelet-rich Fibrin Compared With Platelet-rich Fibrin Alone

Cairo University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2022年5月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
24
试验地点
1
主要终点
bucco-palatal width of the alveolar socket after extraction with millimeter by cone-beam computed tomography (CBCT)

研究概览

简要总结

Bone marrow aspiration from maxillary tuberosity will be centrifuged to separate the bone marrow mononuclear cell layer using the density gradient separation method, then it will be seeded in a platelet-rich fibrin membrane and used for socket preservation to test the osteogenic ability of the bone marrow mononuclear cell layer in comparison to platelet-rich fibrin alone both ways will receive implant after 3 months

详细描述

-Research question: In patients with teeth requiring extraction will bone marrow mononuclear cell layer (BMMNC) from maxillary tuberosity seeded on platelet-rich fibrin (PRF) maintain the bucco-palatal/lingual bone dimension during socket preservation compared to platelet rich fibrin alone?

-The rationale for conducting the research: Bone marrow is full of progenitors and cell markers that promote tissue healing. Traditionally bone marrow aspiration is done from extra-oral sites. The obstacle in extra-oral aspiration is the site morbidity and the need to put the patient under general anesthesia.

Intraoral sites like the maxillary tuberosity are filled with marrow spaces that can facilitate the harvesting of marrow cells and reduce the trauma of the harvesting process.

Bone marrow mononuclear cell (BMMNC) transplantation may result in higher rates of bone marrow regeneration in the extraction socket and significantly accelerate bone maturation. It is also suggested that Bone marrow mononuclear cell (BMMNC) plays an important role in bone homeostasis within the extraction socket However, Bone marrow mononuclear cell (BMMNC) has several drawbacks that should be taken into consideration like potential pain during harvest, and variable stem cell quantity and quality depending on age which may hinder the usage of Bone marrow mononuclear cell (BMMNC) in old ages.

The bone regeneration ability of that population of cells and the ease of their acquisition render them good candidates for socket preservation. Hence, the current study aims to evaluate the use of Bone marrow mononuclear cells (BMMNC) obtained from the maxillary tuberosity in promoting bone formation in the alveolar socket after extraction.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

Blinding of the participants and the operator is is not applicable, however outcome assessors and biostatistician will be blinded.

入排标准

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

入选标准

  • Patients with badly decayed tooth indicated for extraction
  • Patients with healthy systemic condition (Medically free)
  • Adequate inter-arch space for placement of the implant prosthetic part.
  • Good oral hygiene
  • Cooperative patients who are willing to commit for 6 months follow up

排除标准

  • Pregnant females
  • Patient with medical condition that contraindicates surgical procedures
  • Patients on medication that may interfere with healing (corticosteroids, bisphosphonate, Chemo/radio therapy).
  • Patients with habits that may jeopardize the implant longevity and affect the results of the study such as alcoholism or parafunctional habits.

结局指标

主要结局

bucco-palatal width of the alveolar socket after extraction with millimeter by cone-beam computed tomography (CBCT)

时间窗: 3 months after extraction and socket preservation

The bucco-palatal width of the alveolar socket after extraction will be measured in millimeter using On Demand software at distinct level (2 , 4, and 6mm from the cerst) at the time of extraction and 3 months later after socket preservation with cone-beam computed tomography (CBCT)

次要结局

  • postoperative pain(14 days)

研究者

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

Hani Elnahass

clinical professor

Cairo University

研究点 (1)

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