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临床试验/NCT05766137
NCT05766137尚未招募不适用

Comparison of The Post-Extraction Dimensional Alterations Following Ridge Preservation Using Autogenous Partially and Completely Demineralized Dentin Grafts Versus Autogenous Whole-tooth Graft: A Randomized Controlled Clinical Trial

Cairo University0 个研究点目标入组 45 人开始时间: 2023年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
45
主要终点
Alveolar ridge width and height changes

研究概览

简要总结

For alveolar ridge preservation after extraction of a non-restorable maxillary non-molar tooth, will the use of Autogenous partially or completely demineralized dentin grafts result in similar ridge dimensions compared to Autogenous whole-tooth graft?

详细描述

One inevitable consequence of tooth loss is alveolar ridge resorption, which is progressive, irreversible, chronic, and cumulative. For implant placement, adequate dimensions of the alveolar ride housing are essential for proper implant positioning to provide for both implant stability and esthetics. Various procedures have been developed to limit post-extraction dimensional alterations or to restore normal bone dimensions, among which is ridge preservation. Numerous materials have been introduced and compared, nevertheless the best option is yet to be determined. Autogenous bone remains the gold standard for bone grafting, however one cannot ignore its unavoidable drawbacks, with donor site morbidity and the need for additional surgery having the biggest impact, as well as the limited amount that can be harvested and the unpredictable resorption rate. Several other options have been introduced with the aim of overcoming these disadvantages.

promising results have been reported, and the use of autogenous tooth bone graft (ATBG) is gaining popularity, since this material has a structure that closely resembles bone, especially the dentin which is composed of similar inorganic and organic elements, and also has osteoinductive and osteoconductive capacity.

Some studies using mineralized dentin matrix have shown that the material possesses excellent biocompatibility but is less effective than bone derived products in bone formation. On the other hand, several basic animal studies have shown that completely demineralized dentin matrix to be not only biocompatible, but also osteo-inductive, similar to demineralized bone matrix. The degree of demineralization is critical for optimal dentin regeneration; the partially demineralized dentin matrix is thought to have optimal conditions for dentin regeneration. Partial demineralization results in the elimination of the major part of the mineral phase and immunogenic components while retaining a very low fraction of minerals (5-10 wt%), providing an osteoconductive and osteo-inductive scaffold containing several growth factors.

It is agreed upon that nowadays optimizing protocols of demineralization of dentin grafts is necessary for standardization and further studies are required to determine the most suitable conditions of demineralization and particle sizes of dentin grafts for clinical application in implant dentistry. Additionally, more research is required to investigate whether graft preparation in its simplest form is sufficient or whether enhancing the graft with demineralization will result in any clinical significance.

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 (Participant, Outcomes Assessor)

盲法说明

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

入排标准

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

入选标准

  • Non-molar maxillary teeth indicated for extraction.
  • Extraction sockets having no more than 50% of buccal alveolar bone loss were included.
  • Patients at least 18 years or older
  • Motivated patients, agree to sign informed consent and complete the follow-up period

排除标准

  • Infection at the extraction site
  • Patients undergoing or having history of radiotherapy, chemotherapy or bisphosphonate therapy.
  • Systemic conditions that may compromise healing or bone metabolism (e.g., uncontrolled diabetes, hyperthyroidism).
  • Females that are pregnant or are planning to get pregnant during the study course.

结局指标

主要结局

Alveolar ridge width and height changes

时间窗: 6 months

Difference in alveolar ridge width and height linear measurements in millimeters between baseline and final CBCT scans after 6 months

次要结局

  • Histological assessment(6 months)

研究者

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

Dina Osama Abdelwahab Megahed

Assistant Lecturer

Cairo University

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