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临床试验/NCT06390124
NCT06390124已完成4 期

Reconstructive Therapy of Advanced Peri-implantitis-related Bone Defect with PDGF-BB (Gem-21)

Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2022年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
11
试验地点
1
主要终点
Rate of disease resolution

研究概览

简要总结

Peri-implantitis is considered a bacteria-mediated inflammatory disease that leads to a progressive loss of support. During the last decade, research has been striving to understand this entity and strategies for primary and secondary prevention of the disease; However, all of them are about the effectiveness of different therapeutic modalities for their management. In general, it was stated that surgical therapy was ineffective in resolving inflammation. Therefore, surgical strategies are usually needed to eradicate the pathology.

Taking advantage of the knowledge acquired during approximately a period of time about the surgical treatment of periodontitis, if you propose several alternatives. These are mainly based on the morphology of the defect, although other factors, such as the lack of keratinized mucosa or the habit of smoking can alter the decision-making process. As such, peri-implantitis with angular defects (i.e., defects with infraosseous components) is indicated for reconstructive measurements with no barrier membranes. On the other hand, horizontal defects (i.e., defects with supra-crestal components) are more likely to resolve by resecting therapy with or without bone contouring measures.

It is interesting to note that, although early data indicated that the morphology of the peri-implantitis defect often shows a well-contained circumferential defect, it has recently been shown that it often presents a 2/3 wall defect configuration, where the buccal plate is commonly missing bone wall. The reason for this characteristic may recur in the dimension of the basal alveolar bones, insufficient critical buccal bone thickness or implant positioning13 in relation to the bone envelope. In addition, it should be noted that ~ 25% of peri-implantitis diagnosed on a daily basis exhibit a combined configuration of defects (i.e., a combination of infraosseous and supra-critical components).

For their reconstructive treatment, many biomaterials have been documented, among them several protocols proposed by our research group. However, the use of biological agents or growth factors has not been investigated for a long time. Platelet Derived Growth Factor (PDGF, Platelet Derived Growth Factor) is one of several Growth Factors or proteins that regulate cell growth and Cellular Division. PDGF plays a significant role, especially for Angiogenesis, which implies the growth of blood vessels from the existing vascular tissue. Uncontrolled angiogenesis is characteristic of cancer. Chemically the PDGF is a Glucoprotein chains A (-AA) or B (-BB) or composed of them (-AB). In the field of periodontics, periodontal regeneration has been shown to be successful in obtaining radiographic bone gain and tissue regeneration.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Experimental group

Experimental

Platelet derived growth factor (PDGF) is to be used to soak the implant surface and in combination with the bone grafting material

干预措施: Platelet Derived Growth Factor (PDGF) (Drug)

结局指标

主要结局

Rate of disease resolution

时间窗: 12 months after surgery

pockets \<6mm with no bleeding on probing

次要结局

未报告次要终点

研究者

发起方
Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alberto Monje

Head of department of Periodontology

Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain

研究点 (1)

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