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临床试验/NCT06513039
NCT06513039招募中4 期

Evaluation of Erythropoietin on Alveolar Ridge Preservation: (A Randomized Controlled Clinical Trial With Histomorphometric Assessment)

Ain Shams University1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2024年1月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
招募中
入组人数
15
试验地点
1
主要终点
Dimensional changes

研究概览

简要总结

regenerative materials would help in decreasing post-extraction resorption in sites indicated for placement of a conventional bridge or prosthetically driven implant. Erythropoietin (EPO) is a growth factor that promotes angiogenesis and bone regeneration by stimulating osteoblastic differentiation and by inhibiting osteoclastic resorption. Post-extraction alveolar ridge resorption creates morphological and volumetric changes. These changes can be considered of clinical value that may threaten the placement of a conventional bridge or an implant-supported crown. Atwood et al. [1] in a cephalometric study categorized factors influencing the rate of alveolar ridge resorption into 4 types: anatomic, metabolic, functional, and prosthetic. As stated by Tan et al. [2] in a systematic review of alveolar hard and soft tissue dimensional changes in humans post-extraction, they found that alveolar ridge resorption occurs to a greater extent in a horizontal direction than vertical. Therefore, alveolar ridge preservation (ARP) procedures were introduced in an attempt to prevent hard and soft tissue dimensional changes following extraction.

详细描述

II. Aim of the study:

To assess the efficiency of Erythropoietin in alveolar ridge preservation.

  1. Objectives:

Primary objective:

Dimensional changes of the ridge clinically and radiographically.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

triple blinding

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age range (18-40).
  • Hopeless teeth indicated for extraction such as root fractures, caries, internal root resorption, external root resorption, endodontic failures.
  • Systemically free patients using Cornell Medical Index-Health Questionnaire [36].
  • Patients diagnosed with intact surrounding alveolar bone (socket type I) [37].
  • Maxillary anterior teeth and/or premolars indicated for extraction.
  • Enough zone of keratinized tissue (≥2 mm).

排除标准

  • Occlusal trauma at the site of the graft
  • Pregnancy and lactation
  • Bad compliance with the plaque control instructions following initial therapy.

研究组 & 干预措施

study group

Experimental

Patient will have extraction of teeth and placement of Erythropoietin carried on chitosan carrier for six months

干预措施: Erythropoietin carried on chitosan carrier (Drug)

positive control

Active Comparator

Patient will have extraction of teeth and placement of chitosan carrier only for six months

干预措施: chitosan carrier (Other)

结局指标

主要结局

Dimensional changes

时间窗: six months

Clinical measurement using bone caliper. Radiographic measurement using CBCT

次要结局

  • Postoperative Pain level Postoperative wound Healing Patterns of bone regeneration of extraction socket(six months)

研究者

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

shehad wael

Doctor

Ain Shams University

研究点 (1)

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