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临床试验/NCT07187609
NCT07187609招募中不适用

Clinical and Radiographic Evaluation of Zinc Incorporated Bovine Derived- Hydroxyappatite Xenograft in Immediately Placed Implant: A Randomized Clinical Study

Suez Canal University1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2025年8月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
16
试验地点
1
主要终点
Marginal bone loss

研究概览

简要总结

The aim of this study is to evaluate Clinical and radiographic effect of zinc incorporated bovine derived hydroxyapatite xenograft and bovine hydroxyapatite xenograft alone for immediately placed implant

详细描述

Implant dentistry is a prosthetic effort via a surgical procedure. In order to achieve an ideal prosthetic construct, precise plan should be taken into consideration prior to the beginning of treatment. The position of implant requires protected prosthesis. It can be affected by the implant size, volume, and the quantity and quality of bone provided at various sites.

One pitfall of immediate implant use, however, is the inevitable residual space that remains between the implant body and the socket wall, due to a discrepancy in size between the implant and the socket wall. This space, which is located toward the coronal end of the implant, is called the jumping distance. Excessive jumping distance may lead to bone resorption and formation of a bony defect, decreasing the implant stability .

One of the most extensively used methods for restoration of the lost attachment is the use of bone grafts. bone grafting which is one of the methods used to address these issues has experienced an increased level of demand.

The problem of bone defects has also contributed to making bone autograft become the gold standard for treating bone abnormalities, although it has its limitations which are graft quantity and donor site morbidity. Contributory,allografts have become popular for replacing bone defects because the graft size can be easily adjusted but it also has several drawbacks, including disease transfer, rejection reactions, non-union, graft resorption, fracture, and donor restrictions A xenograft is one of the choices used to overcome these limitations since the raw material is plentiful, readily available, and inexpensive. Additionally, several previous studies showed that organic or inorganic matrix derived from bovine bone is biocompatible, but this biomaterial requires proper preparation to avoid risks such as the transmission of zoonoses .

Bovine hydroxyapatite is made up of materials which have biological properties that makes it biocompatible and osteoconductive. These important biological properties allow the apposition of newly formed bone by osteoprogenitor cells and the partial remodeling by osteoclast and osteoblast of the host . Hydroxyapatite is used as scaffolds to support the development of bone tissue from an osteoblast proliferation stage through to extracellular matrix (ECM) deposition and on to cell-mediated early-stage mineralization. The addition of small quantities of hydroxyapatite to the scaffolds considerably increases calcium deposition and has a mild osteogenic impact.

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
None

入排标准

年龄范围
21 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Adult(male or female) patients between the ages of 21 -50 years who requiring the replacement of one or more non-restorable teeth in the mandible which will be indicated for extraction.
  • •Adequate bone dimensions at the implant site with ridge width of at least 6 mm, the availability of at least 3mm of sound subapical bone, the presence of an intact labial bone plate, and no evidance of periapical infection on cone beam computed tomography or clinically
  • •The peri-implant gaps larger than 1.5 mm will be included.
  • •All patients will be physically healthy with no medical history of any systemic disease.

排除标准

  • •Patients with para functional habits such as bruxism and clenching
  • •Poorly controlled systemic diseases which preclude local anesthesia or surgical procedures
  • •Patients undergoing chemotherapy or radiotherapy and immuno-compromised patients.
  • •Pregnant /lactating women.
  • •Patients that are allergic to zinc
  • •Patients on antibiotic therapy in the pervious 6 months

研究组 & 干预措施

Group I (control)

Experimental

patients will undergo immediate implant with bovine drived hydroxyapatite xenograft

干预措施: Immediate implant with bovine drived hydroxyapatite xenograft. (Procedure)

Group II (Test group)

Experimental

patients will undergo immediate implant with zinc incorporated bovine drived hydroxyapatite xenograft

干预措施: immediate implant with zinc incorporated bovine drived hydroxyapatite xenograft (Procedure)

结局指标

主要结局

Marginal bone loss

时间窗: 9 months

Marginal bone loss was defined as the distance from the implant platform to the alveolar crest.

次要结局

  • densitometric gray scale value to measure bone density(9 months)

研究者

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

Ibrahim montasser

Resident

Suez Canal University

研究点 (1)

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