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临床试验/NCT06398288
NCT06398288已完成不适用

Adjunctive Use of Dermal Matrix to Compensate Dimensional Changes in the Reconstructive Therapy of Peri-implantitis: Multi-Center Randomized Controlled Trial

Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2024年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
48
试验地点
2
主要终点
Rate of disease resolution of peri-implantitis (%)

研究概览

简要总结

One critical element regarded to successfully resolve peri-implantitis is to efficiently decontaminate the contaminated implant surface. Mechanical, pharmacological and chemical strategies have been proposed to eliminate bacterial plaque and remnants from the implant surface. However, evidence has not demonstrated superiority of a given detoxification agent/strategy. Recently, the electrolytic approach has been indicated for the surgical detoxification in the management of peri-implantitis. For the electrolytic approach (EA) the implant has to be loaded negatively with a voltage and a maximum current of 600 mA. This is achieved by a device (GS1000, GalvoSurge Dental AG, Widnau, Switzerland) providing the voltage and pumping a sodium formiate solution through a spray-head, which has to be pressed into the implant by finger pressure to achieve an electrical contact.

Another critical aspect in the management of peri-implantitis is related to the esthetic sequelae associated with disease resolution. Sanz-Martin et al. in a systematic review demonstrated that reconstructive therapy is less prone to exhibit mucosal recession when compared to resective therapy. Nonetheless, it seems to be unavoidable no matter the surgical intervention. Aiming at attenuating these changes, Schwarz et al. noted that the adjunctive use of connective tissue grafts may enhance the height of the mucosal level, which in turn may impact upon the esthetic outcome. Therefore, the research question is the following: What is the clinical, radiographic and 3D volumetric effectiveness of dermal matrix to improve the outcome of reconstructive therapy of peri-implantitis-related bone defects? The study is to be performed in two centers: Center of Implantology, Oral and Maxillofacial in Badajoz (Spain) and Clinical PerioCentrum Ortiz-Vigon in Bilbao (Spain)

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
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with peri-implantitis-related intrabony defects
  • All subjects had dental implants with screw-retained or cement-retained fixed or removable implant-supported prosthesis for a minimum of 36 months.
  • All patients in age of 18 to 80, non-smokers
  • With no presence of systemic disease or medication known to alter bone metabolism, and partial or complete edentulous patients that have no active periodontal disease.

排除标准

  • Peri-implantitis-related supra-crystal or combined defects
  • Pregnancy or lactation
  • History of or current smokers
  • Uncontrolled medical conditions,
  • Cement-retained restorations,
  • Lacking keratinized mucosa (≤2mm) on the lingual or buccal implant sites.

研究组 & 干预措施

Test group (Oracell group)

Experimental

Mechanical detoxification using curettes + NiTi brushes + EA (GalvoSurge) for 2 minutes + a mixture of anorganic bovine bone (Straumann Xenograft, Straumann) and cortical mineralized/demineralized allograft (Oragraft, Lifenet Health) + dermal matrix on the buccal aspect (Oracell, Lifenet Health)

干预措施: Dermal matrix (Oracell, LifeNet, USA) (Other)

Control group (no Oracell group)

Experimental

Control group: Mechanical detoxification using curettes + NiTi brushes + EA (GalvoSurge) for 2 minutes + a mixture of anorganic bovine bone (Straumann Xenograft, Straumann) and cortical mineralized/demineralized allograft (Oragraft, Lifenet Health)

干预措施: No dermal matrix (Other)

结局指标

主要结局

Rate of disease resolution of peri-implantitis (%)

时间窗: 12 months

No bleeding, no pocket depth ≥6mm, no progressive bone loss. Appraised in %

次要结局

  • Reduction in mm of mucosal recession(12 months)
  • Evolution of microbial profile (characteristics of the microbiota)(12 months)

研究者

发起方
Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
申办方类型
Other
责任方
Sponsor

研究点 (2)

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