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临床试验/NCT05811390
NCT05811390已完成不适用

Non-surgical Treatment of Periimplantitis - Conventional Hand Instrumentation Versus Air-polishing and Systemic Metronidazole With a 12 Months Follow-up, a Parallel Randomized Controlled Clinical Trial

Universidade do Porto2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2022年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
2
主要终点
Change in probing pocket depth

研究概览

简要总结

The purpose of this study is to evaluate the clinical efficacy of ultrasonic instrumentation versus the use of an erythritol jet in the treatment of peri-implantitis.

详细描述

To carry out this study, the investigators considered a treatment protocol for periimplantitis consisting of 2 phases. The first phase corresponds to the non-surgical treatment of periimplantitis, which can be performed using various techniques. In the present study, it will be carried out using manual instrumentation (with ultrasound and curettes) or with an erythritol jet. In both cases, systemic antibiotic therapy with metronidazole will be performed. The results obtained during the follow-ups will allow the evaluation of the effectiveness of the treatment carried out. If this does not prove to be successful, through an evaluation of clinical and radiographic criteria, patients will be advised to undergo a second phase of treatment, in this case a surgical treatment of peri-implantitis, but which will no longer be part of the interventions carried out and documented in this study. Patients for whom the unsatisfactory treatment was considered effective will be allocated to a periimplant support treatment program, which means that they will be advised to carry out maintenance consultations at the FMDUP clinic with a specific and individualized periodicity in order to maintain the health of the periimplant tissues and the remaining oral cavity. The study will be carried out by the students of the Specialization in Periodontology and Oral Implantology 2021-2024 of the Faculty of Dental Medicine of the University of Porto (FMDUP).

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
Single (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

入选标准

  • At least 1 osseointegrated implant diagnosed with peri-implantitis (according to the new Classification of Periodontal and Peri-implant Diseases and Conditions) and rehabilitated with screw-retained crown
  • Patients of legal age (≥18 years old)

排除标准

  • Uncontrolled systemic pathologies, namely diabetes mellitus (HbA1c > 7% or >53 mmol/mol)
  • Pregnant or lactating patients
  • Severe smoking (>20 cigarettes/day)
  • Systemic pathologies, medication or treatments that cause alterations in bone metabolism (for example: osteoporosis, bisphosphonates, radiotherapy of the head and neck)
  • Patients who missed study control visits
  • Patients who have received systemic antibiotic therapy in the last 2 months
  • Patients with allergies to any of the components used in the study, namely to erythritol
  • Implants that have previously undergone surgical treatment for peri-implantitis
  • Implants with bone loss greater than 2/3 of their length and/or mobility

结局指标

主要结局

Change in probing pocket depth

时间窗: 0, 3, 6, 12 months

The distance measured from the base of the sulcus or pocket to the free gingival margin at six points per implant (measured in millimetres).

次要结局

  • Change in alveolar bone level(0,12 months)
  • Implant survival rate(0, 12 months)
  • PROMS(0 months)
  • Change in gingival recession(0, 3, 6, 12 months)
  • Bleeding on probing(0, 3, 6, 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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