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临床试验/NCT05225142
NCT05225142已完成不适用

Modified Minimally Invasive Surgical Technique in Human Intrabony Defects With or Without Regenerative Materials 10-year Follow-up of a Randomized Clinical Trial: Tooth Retention, Periodontitis Recurrence and Costs

The European Research Group on Periodontology (ERGOPerio)2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2007年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
45
试验地点
2
主要终点
Clinical attachment level changes

研究概览

简要总结

Evaluate the 10-year stability clinical, radiographic outcomes obtained with the application of the modified minimally invasive surgery to deep pockets associated with intrabony defects.

详细描述

This 10-year follow-up of a randomized controlled clinical trial (Cortellini & Tonetti 2011) compares three treatment modalities in deep intrabony defects: i) a control group was treated with modified minimally invasive surgical technique alone (M-MIST, N=15); ii) a second group was treated with M-MIST combined with enamel matrix derivative (M-MIST EMD, N=15, Straumann, Switzerland); iii) a third group was treated with M-MIST+EMD plus Bone Mineral Derived Xenograph (M-MIST+EMD+BMDX, N=15, Geistlich, Switzerland) . The design of the original trial has been reported along with the one-year results and the details of randomization and allocation concealment (Cortellini & Tonetti 2011). Clinical outcomes of the three groups were longitudinally followed for 10 years. The 10-year follow-up was approved by the local ethical committee for clinical research of the Health Service of Tuscany (University Hospital of Firenze protocol ATRO2019, registration n° 15106_oss). All patients gave informed consent to participate into the clinical trial.

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 (Investigator, Outcomes Assessor)

盲法说明

Allocation concealment of surgeon until completion of common part of surgical intervention. Examiner (clinical and radiographic ) and other carers blind to allocation

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

  • Subjects with periodontitis
  • Presence of one intrabony defect not extending into furcation
  • Good general health
  • Adequate plaque control

排除标准

  • Furcation involvement in the experimental tooth
  • Inadequate control of periodontitis

结局指标

主要结局

Clinical attachment level changes

时间窗: 10 years

Periodontal probing to the nearest millimetre

次要结局

  • Probing pocket depts(10 years)
  • Tooth survival(10 years)
  • Complication-free survival(10 years)
  • Cost of recurrence(10 years)
  • Radiographic bone level(10 years)

研究者

发起方
The European Research Group on Periodontology (ERGOPerio)
申办方类型
Network
责任方
Sponsor

研究点 (2)

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