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临床试验/NCT05553548
NCT05553548尚未招募不适用

Alveolar Ridge Changes With Biologically Oriented Alveolar Ridge Preservation (BARP) After Tooth Extraction : A Randomized Clinical Trial

Cairo University2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2022年10月20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
36
试验地点
2
主要终点
Horizontal radiographic changes in bone dimensions

研究概览

简要总结

After tooth extraction, the alveolar process undergoes substantial horizontal and vertical resorption specifically in non-molar sites, where horizontal, vertical mid- facial, and mid-lingual ridge reduction could occur . These dimensional changes are clinically relevant, as they may affect dental implant placement and compromise soft tissue aesthetics.

Alveolar ridge preservation (ARP) is based on the application of a bone replacement graft into the extraction socket & collagen membrane/plug. Recent systematic reviews have shown that ARP may limit bone resorption to about 50% of what is normally observed in case of unassisted healing . This finding indicates that ARP is effective; but at the same time, it underlines the potential for improvement.

详细描述

In ARP procedures based on socket grafting, the use of a bone replacement graft would prevent up to a 30% of volume reduction in the coronal third. Whereas it has limited effect in the remaining middle-apical thirds . Since grafting of the alveolus often results in the persistence of residual graft particles embedded into the newly formed bone with a delay in the rate of bone deposition and mineralization the need to extend the grafting procedure apical to the coronal third of the socket seems questionable. Based on these considerations, a novel, simplified technique, namely, the Biologically-oriented Alveolar Ridge Preservation (BARP) for ARP that restricts socket grafting to the coronal portion of the socket was presented .

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)

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

  • Adults 18 years old or more.
  • Patients with good oral hygiene, defined as a full-mouth plaque score ≤25% (O'Leary et al., 1972).
  • Patients who need alveolar ridge preservation after tooth extraction at one or two sites in the aesthetic zone (incisor, cuspid, or premolar area in the maxilla or mandible) with >50% buccal bone present following tooth extraction (Eeckhout et al., 2022) .
  • One or two neighboring teeth.
  • Compliant patients who will sign an informed consent and agree to the follow up period.

排除标准

  • • Uncontrolled systemic disease
  • Past or current smoking
  • Untreated or unstable periodontitis
  • Untreated caries lesions.

结局指标

主要结局

Horizontal radiographic changes in bone dimensions

时间窗: 4 months

Horizontal measurements will be performed perpendicular and parallel to the tooth axis, respectively. The level of the palatal bone crest preoperatively will be used as a reference line (level 0). The horizontal dimension of the alveolar process will be registered at 1, 3, and 5 mm apical to this reference line (level 1, 3, and 5). After performing all measurements on the CBCT (T1), the software switched to the superimposed image (T4) so that the measurements could be performed while using the same reference levels. Finally, changes in bone dimensions will be calculated by subtracting bone dimensions at T4 from that at T1.

次要结局

  • Changes of soft tissue height at the buccal , lingual & central aspects of the site.(4 months)
  • Vertical radiographic changes in bone dimensions(4 months)

研究者

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

Nevein Mohammed Osama Al-Gammal

Assisstant lecturer In periodontology department Future university in Egypt

Cairo University

研究点 (2)

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