跳至主要内容
临床试验/NCT06621719
NCT06621719已完成不适用

Evaluation of Secondary Alveolar Cleft Reconstruction Using Bone Matrix Prepared From Cancellous Particulates Mixed With Albumin-PRF or L-PRF: (A Randomized Controlled Clinical Trial)

Beni-Suef University2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2024年11月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
2
主要终点
The bone bridge formation rate

研究概览

简要总结

The rehabilitation of the disorganized maxilla is the primary objective of secondary alveolar bone grafting (SABG) for alveolar clefts, as the bony reconstruction of the discontinued maxillary arch would permit proper anterior teeth eruption, improve their orthodontic movements, restore the nasal and alar base symmetry, counteract the growth disturbance effects and seal the oronasal communication. By the time the transverse growth of the maxillary arch is nearly complete during the mixed dentition stage, (SABG) intends to bridge the maxillary continuity by a quantitative bone graft entity that minimizes the maxillary collapse and growth impairment after an appropriate separation and elevation of the nasal and mucosal flaps.

详细描述

By its ample content of subcutaneous autogenous cancellous bone particulates, the iliac crest is considered the gold standard for (SABG) of alveolar clefts, with optimal restoration of the maxillary continuity, and fair subsequent teeth eruption, orthodontic movements or implant placement. However, several studies have demonstrated that the final volume of the sole iliac crest particulate graft is unpredictable.

Sohn et al. in 2010 introduced the growth-factors enriched bone matrix "sticky bone" concept that incorporates the platelet-rich fibrin (PRF) into the particulate grafts to enhance their moldability and enrich them with three-dimensional (3D) fibrin networking scaffold and high concentrations of growth factors, which promote cell division, modulate tissue healing and induce angiogenesis, such as vascular endothelial growth factors (VEGF), recombinant human platelet-derived growth factor (rhPDGF), transforming growth factors ß-1 (TGFß-1), bone morphogenic protein-2 (rhBMP2), insulin growth factor-I (IFG-I), and epithelial growth factor (EGF), and interleukins.

During the last decade, various (PRF) preparations and centrifuge protocols have been developed, forming various platelet products with different biological constitutions and potential applications. The (PRF) evolution began with the development of the leukocyte- and platelet-rich fibrin (L-PRF) by an increased centrifuge time and speed, followed by advanced platelet-rich fibrin (A-PRF), injectable platelet-rich fibrin (I-PRF), horizontal platelet-rich fibrin (H-PRF), Concentrated PRF (C-PRF) and most recently the albumin-PRF (Albumin gel).

The (L-PRF) employs the extract of the platelet-rich plasma (PRP) in the form of a fibrin clot, meanwhile discarding the platelet-poor plasma (PPP). On the other hand, the albumin gel preparation employs the aspiration and heating of the platelet-poor plasma (PPP), the upper layer, then remixing it with the (PRP) layer and the buffy coat; the lower layers, after being allowed to cool. Although the heating and cooling process would threaten the vitality of cells and the growth factor of the (PPP) layer, this will polymerize its plasmatic proteins and denature the high albumin content as a result of the replacement of the weak hydrogen bond linkages within the protein molecule, with densely organized ones, in addition to the formation of thermal aggregate cross-linkage fibrin networks with an overall endured mechanical strength, prolonged degradation time up to 4-6months, and extended release of growth factors up to ten days.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
9 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients of both sexes with unilateral secondary maxillary alveolar cleft, during the mixed dentition stage with an age range of (eight to twelve years old)
  • Good general good health and proper state of oral hygiene.

排除标准

  • The detection of maxillary pathosis or palatal fistulae during the radiographic or clinical examination.
  • Patients with systemic disorders that would compromise the bone harvest or graft outcomes, those with cleft-associated syndromes or a history of previous failed (SABG)

结局指标

主要结局

The bone bridge formation rate

时间窗: 6 months

The patients will be followed up immediately after surgery and then monthly during the six-month graft consolidation period. Immediate postoperative and six-month postoperative Cone beam xray will be undertaken for the patients, which will be superimposed to compare the exact extent of vertical and horizontal bone loss between the cases of the study and control groups.

The graft fill rate

时间窗: 6 months

The patients will be followed up immediately after surgery and then monthly during the six-month graft consolidation period. Immediate postoperative and six-month postoperative Cone beam xray will be undertaken for the patients, which will be superimposed to compare the exact extent of vertical and horizontal bone loss between the cases of the study and control groups.

The graft resorption rate

时间窗: 6 months

The patients will be followed up immediately after surgery and then monthly during the six-month graft consolidation period. Immediate postoperative and six-month postoperative Cone beam xray will be undertaken for the patients, which will be superimposed to compare the exact extent of vertical and horizontal bone loss between the cases of the study and control groups.

Bone bridge density values:

时间窗: 6 months

The patients will be followed up immediately after surgery and then monthly during the six-month graft consolidation period. Immediate postoperative and six-month postoperative Cone beam xray will be undertaken for the patients, which will be superimposed to compare the exact extent of vertical and horizontal bone loss between the cases of the study and control groups.

次要结局

未报告次要终点

研究者

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

Ahmed Nagi Alghandour

Lecturer

Beni-Suef University

研究点 (2)

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