Effect of Plasma of Argon Cleaning on Implant Abutments in Patients With a History of Periodontal Disease and Thin Biotype: Five Years Post-loading Results of a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Success Rate of the Implants and Prostheses (Participants).
研究概览
简要总结
Contamination of implant abutments could potentially influence the peri-implant tissue inflammatory response. The aim of the present study was to assess the radiographic bone changes around customized, platform switched, abutments placed according to the "one-abutment-one-time" protocol, with and without plasma of argon cleaning treatment.
详细描述
After technical procedures, presence of contaminants (mostly Titanium wear micro-particles, Carbon and Aluminum traces due to lubricant used during customization) on the whole abutment surface, the internal connection and the screw can be found, even after the usually cleaning steps (steaming).
Such debris, present at titanium/connective-bone tissues interface (gingival portion of the abutment), could directly or indirectly deleteriously influence the inflammatory response on the peri-implant tissues.
Plasma of Argon cleaning treatment was demonstrated to have a double effect on titanium abutments: removal of pollutions following customization and increase of cell adhesion. Additionally, Plasma of Argon demonstrated very potent anti-biofilm activity. This prospective, match paired, triple-blinded randomized controlled trial was aimed to test if plasma treatment of customized abutments can affect radiographic peri-implant marginal bone level changes after 5 years of prosthetic loading.
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
- 否
入选标准
- •Patients aged 18 years or older, previously treated for periodontal disease according to a comprehensive treatment strategy,25 requiring a single implant-supported restoration in the anterior maxilla or premolar region with the presence of mesial and distal tooth.
- •Bone crest allowing the insertion of a 4 mm platform implant without further bone augmentation procedures and with thin (≤ 1 mm) gingival biotype, measured by previously reported protocol.
排除标准
- •no relevant medical conditions;
- •non-smoker or smoking ≤ 10 cigarettes/day;
- •plaque Index and bleeding on probing ≤ 25 %;
- •impossibility of follow-up for 5 years after prosthetic loading;
- •pregnant and lactating patients;
- •patients with a history of bisphosphonate therapy;
- •presence of sites with acute infections.
结局指标
主要结局
Success Rate of the Implants and Prostheses (Participants).
时间窗: During all the follow-up (5 years)
An implant was considered a failure if it presented any mobility, assessed by tapping or rocking the implant head with the metallic handles of two instruments, and/or any signs of radiolucency, progressive marginal bone loss or infection, and any mechanical complications (e.g. implant fracture) rendering the implant unusable, though still mechanically stable in the bone. This was evaluated on an intraoral radiograph taken with a paralleling technique strictly perpendicular to the implant-bone interface. The implant stability was assessed at initial loading and following 3 years of application, with the prostheses removed. A prosthesis was considered a failure if it needed to be replaced by an alternative prosthesis.
次要结局
- Any Biological or Technical Complications.(During all the follow-up (5 years))
- Peri-implant Marginal Bone Level Changes (Express in mm).(At 5 years.)
- Esthetic Parameters Measured as the Changes in Mesial and Distal Papilla Height (PH) and Buccal Peri-implant Mucosa Changes at the Zenith (REC), Expressed in mm.(At 5 years.)
- Percentage of Patients With Plaque Index(At 5 years.)
- Percentage of Patients With Bleeding on Probing(At 5 years.)
研究者
Luigi Canullo
Clinical researcher, study adviser
University of Valencia