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临床试验/NCT06758440
NCT06758440已完成不适用

Effectiveness of Hydroxyapatite Reinforced Chitosan Hydrogel in Modulation of Osseintegration Round Immediate Dental Implant Randomized Single Blind Control Study

Minia University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年3月28日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
Clinical assessment of osseintegration

研究概览

简要总结

Dental implant treatments have now become indispensable in clinical dental practice. The survival rate exceeds 90%; Modern oral implantology uses different devices, in terms of size, shape, length, thickness and composition, from pure titanium to titanium-aluminum-vanadium alloys, due to their biocompatibility and high corrosion resistance

详细描述

Immediate implants placed in freshly extracted sockets are an alternative treatment for traditional dental implants reduces physiological resorption of alveolar ridge, provides fast and simple procedures , decreasing the number of dental appointments, shortening length of treatment time, lesser surgical intervention, and ideal axial orientation of the implant.

However, the biological response of tissues can be improved by different surface treatments that provide both bioactivity and osseointegration capacity. Many materials have been advocated for boosting up the bone regeneration.

Current trends are directed not only towards achieving optimal osseointegrative surfaces, but also towards antibacterial activity for prolonged periods of time, either by blocking microbial adhesion and preventing late infections.

Given their biocompatibility and biodegradability, natural polymers are widely used materials for bone grafting. Among them, chitosan, collagen, silk fibroin, gelatin, cellulose, alginate. Chitosan is an excellent candidate for bone reconstruction as it has antimicrobial properties, can generate porous structures suitable for cell growth and osteoconduction, and promotes osteoblast cell proliferation. Furthermore, its structure is similar to glycosaminoglycans, a component of the bone extracellular matrix.

Chitosan has been formulated in different systems for bone tissue engineering, including scaffolds, sponges, hydrogels, micro-nanospheres, and membranes, among others ; capable of accelerating the formation of new bone integrated into the host bone without causing adverse 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
Double (Participant, Investigator)

入排标准

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

入选标准

  • Healthy patients (class I category according to American society of anesthesiologists )
  • Over 20 years and under 50 years of age
  • Either gender
  • Patients seeking extraction and placement of immediate dental implant for mandibular teeth.

排除标准

  • Any acute infection in surgical sites
  • Long term non-steroidal anti-inflammatory drug therapy
  • Periodontal disease with bone loss
  • Known allergy to any of the materials used in the study
  • Patients with severely atrophic ridges requiring a staged grafting procedure
  • Patients with significant medical condition
  • Alcoholic individuals
  • Patients on drugs that affect the central nervous systems
  • Patients who reported the use of drugs that might interfere with pain sensitivity
  • Pregnant and lactating

研究组 & 干预措施

Group A

Active Comparator

About 10 patients injected by chitosan/ hydroxyapatite hydrogel in the extracted socket in a back fill injection manner prior to immediate implant placement and then covered with HemCon dental dressing Pro

干预措施: chitosan (Drug)

Group B

Active Comparator

About 10 patients received dental immediate implant placement Spectra system

干预措施: chitosan (Drug)

结局指标

主要结局

Clinical assessment of osseintegration

时间窗: 6 months

Early follow up was performed daily for appearing any complications pre-operative or post-operative.

次要结局

  • Radiographic assessment(6 months)

研究者

发起方
Minia University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tarek Abdelbarry

Lecturer of Oral and Maxillofacial Surgery

Minia University

研究点 (1)

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