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临床试验/NCT06693921
NCT06693921已完成不适用

Artificial Intelligence-Enhanced Three-Dimensional Reconstruction of Combined Horizontal and Vertical Ridge Deficiencies Using Allogenic Dentin Block Versus Shell Tooth Graft Combined With Simultaneous Implant Placement

Kafrelsheikh University2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2024年11月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
2
主要终点
Horizontal buccolingual ridge width

研究概览

简要总结

n the current study, AI-assisted 3D ridge augmentation of combined vertical and horizontal deficient ridges utilizing allogenic dentin block versus allogenic dentin shell graft will be assessed.

详细描述

Severe periodontitis, trauma, and long-term edentulism can cause significant resorptive alterations of the alveolar ridge, leading to severe bone defects in the esthetic zone. Careful hard and soft tissue evaluation prior to implant surgery is important to restore proper function and esthetics. Horizontal, vertical, or combined ridge defects after extraction significantly influence dental implant placement and its long-term stability, as well as the final esthetics outcome.

Under natural conditions following a tooth extraction, the alveolar bone around the empty socket would undergo resorption and the alveolar ridge would recede in height and width. Besides leading to aesthetic and functional issues, the reduced bone volume would also cause insufficient support to the dental implant, causing the implant to become loose and unstable. For patients facing such issues, alveolar ridge augmentation is necessary to regenerate the bone tissue and restore the alveolar ridge so as to ensure the long-term stability of the implant.

Although a large number of alloplastic, allogenic or xenogenic bone substitute materials are available for reconstruction of the alveolar crest, the use of autogenous bone is still considered the gold standard. Autogenous bone has excellent osteoinductive, osteoconductive and osteogenetic characteristics; immunological reactions or the transmission of diseases can be safely avoided, and predictable augmentation results can be obtained.

For several years, the use of dentin as an alternative autogenous material for alveolar crest reconstruction and the grafting of bone deficits has been described and investigated in animal experiments and clinical studies. Dentin is a suitable grafting material because it is very similar to bone in its organic and inorganic composition. Similar to the alveolar bone, about 90% of the organic substance of dentin consists of type I collagen. Also, osteogenetically relevant structural proteins, such as osteocalcin, osteonectin, phosphoprotein and sialoprotein, can be found in dentin. Moreover, dentin contains osteogenetically active factors, including bone morphogenetic protein 2 (BMP-2), tissue growth factor-ß (TGF-ß) and insulin- like growth factor-2 (IGF-2). As in alveolar bone, the inorganic components of dentin consist of various calcium phosphates such as hydroxylapatite, ß-tricalcium phosphate, octacalcium phosphate and amorphous calcium phosphate. Compared with autogenous bone, the use of dentin offers the advantage of avoiding the harvesting procedure and the possible resulting donor site morbidity with promising clinical and histological results owing to its inherent osteoinductive and osteoconductive capacity. In comparison to autogenous bone block graft, dentin grafts also show significantly less resorption.

However, autogenous dentin graft has limitations despite its proven bone-formation capacity: dependence of the quantity on the number of teeth indicated for extraction and the condition of the extracted teeth, lack of a standard method to process autogenous dentin graft, and patient preference. Therefore, the application of dentin graft material from other individuals- allogeneic dentin graft-has been considered as an alternative autogenous dentin graft. Allo-dentin graft was conceptualized from the demineralized bone matrix, which was largely developed and defined for the bone induction principle, which states that a protein macromolecule in dentin and bone induces the differentiation of mesenchymal cells into osteoblasts; this was postulated by Urist in 1965. The Allo-dentin graft is a refined allograft that has osteoinductivity and has been clinically used since the 1980s. Very few studies have investigated the application of Allo-dentin graft as bone substitutes for bone graft surgery. The narrative review of revealed that Allo-dentin graft has demonstrated a great potential for osteoinductivity in extraskeletal sites, maximum clinical safety and efficacy without antigenicity nor provoked immunologic reactions.

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)

盲法说明

single blinded only the outcome assessor is masked

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Insufficient vertical and horizontal bone contour for dental implant placement in the maxillary esthetic zone.
  • Volunteer for participating alveolar bone augmentation by allo-dentin graft technique.
  • Absence of any complicating systemic condition that may contraindicate surgical procedures.
  • Adequate oral hygiene.

排除标准

  • Uncontrolled systematic disorders
  • diabetes mellitus
  • uncontrolled periodontal disease
  • history of head and neck radiotherapy
  • pregnancy
  • noncompliant patients
  • uncooperative individuals
  • those unable to attend the study follow-up appointments

研究组 & 干预措施

allogenic dentin block

Experimental

Participants will receive allogenic dentin block for reconstruction of combined vertical and horizontal ridge defects with simultaneous implant placement in the maxillary esthetic zone.

干预措施: AI/guided block graft (Procedure)

allogenic dentin shell

Experimental

Participants will receive allogenic dentin shell for reconstruction of combined vertical and horizontal ridge defects with simultaneous implant placement in the maxillary esthetic zone.

干预措施: AI/guided shell graft (Procedure)

结局指标

主要结局

Horizontal buccolingual ridge width

时间窗: 12 months

Measuring the buccolingual width of the ridge will be carried out by calculating the distance between the outer boundaries of the palatal and facial bony plates horizontally at a distance 2 mms away from the implant shoulder apically using CBCT.

次要结局

  • Facial marginal bone level(12 months)
  • Peri-implant bone density(12 months)

研究者

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

Walid Elamrousy

Assistant professor of periodontology, faculty of oral and dental medicine

Kafrelsheikh University

研究点 (2)

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