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临床试验/NCT05536479
NCT05536479尚未招募不适用

Clinical, Radiographic and Histomorphometric Evaluation of Autogenous Stored Versus Autogenous Fresh Mineralized Dentin Graft for Alveolar Ridge Preservation: A Randomized Controlled Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年10月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
1
主要终点
Change in buccolingual horizontal alveolar ridge width

研究概览

简要总结

Tooth extraction triggers a cascade of biological events mediated by both the local inflammatory response that follows the surgical intervention and the deprivation of masticatory stimulation of the periodontium, which elicit an alteration of the homoeostasis and structural integrity of the periodontal tissues. Bone remodeling kicks off after tooth loss and continues for several months with most changes taking place in the first three months.

Interestingly, Schmidt-Schultz and Schultz, found that intact growth factors are conserved even in the collagenous extracellular matrix of ancient human bone and teeth. Thus, the application of stored dentin may have similar benefits as fresh dentin, preserving intact growth factors for a prolonged period avoiding the need to perform multiple surgical interventions simultaneously. The volume of the particulate dentin is more than twice of the original root volume. Thus, the idea of using autogenous stored mineralized dentin grafts (ASMDG) in ARP evolved.

详细描述

Immediately following tooth extraction, the alveolar ridge comes across its normal physiologic healing process that results in respective alveolar bone loss, structural and compositional changes of the covering soft tissues, as well as morphological alterations.

In an attempt to cutback horizontal and vertical ridge losses, various techniques have been successfully proven to preserve the alveolar ridge including autografts, allografts, xenografts, alloplasts and autogenous dentin grafts. However, fresh autogenous bone graft is still considered gold standard since it exhibits bioactive cell instructive matrix properties and is non-immunogenic and non - pathogenic in spite of the need for harvesting bone and possible morbidity resulting from it. Nevertheless, no gold-standard technique is applicable for every clinical situation.

The similarities between dentin and alveolar bone may help the human body to show an acceptable biological behavior to dentin graft. It is therefore not surprising that dentin that comprises more than 85% of tooth structure can serve as a native bone grafting material, which is reflected by the interaction between mineralized dentin and osteogenic cells that attach and produce mineralized bone matrix directly on the dentin graft.

Mineralized dentin particles have the advantage to maintain its mechanical stability, allowing early loading after grafting in fresh sockets and bone defects where the mineralized dentin is firmly integrated with newly formed bone, creating a solid site for anchorage of dental implants.

Fresh ground dentin has been used successfully as a grafting material alternative in alveolar ridge preservation which has been manifested in that the clinically grafted sites demonstrated limited ridge resorption which allowed for subsequent implant placement without the need to use additional graft biomaterials.

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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Potential candidates requiring extraction of maxillary non-molar teeth.
  • Periodontally healthy adjacent teeth.
  • Extraction sockets having no more than 50% of buccal alveolar bone loss

排除标准

  • Patients reporting systemic conditions that may compromise healing or bone metabolism (e.g., uncontrolled diabetes, hyperthyroidism).
  • Patients having a history of radiotherapy, chemotherapy, or bisphosphonate therapy.
  • Females who were pregnant or planning to get pregnant during the study course.
  • Root canal treated teeth and teeth with acute infection at the site of extraction

结局指标

主要结局

Change in buccolingual horizontal alveolar ridge width

时间窗: 4 months

The horizontal buccolingual alveolar ridge width will be measured radiographically on a CBCT at three levels: at -1 mm, -3 mm, -5 mm below the most coronal aspect of the crest (HW-1, HW-3, HW-5), and clinically by a caliper at -3 mm and -5 mm (HW-3 and HW-5). Measurements will be taken at baseline and after 4 months postoperatively to calculate the change.

次要结局

  • Postoperative pain(24 hours)
  • Alveolar buccal ridge height(4 months)

研究者

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

Nada Mohamed Wahsh

Principal investigator. Nada Wahsh

Cairo University

研究点 (1)

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