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临床试验/NCT06093360
NCT06093360已完成不适用

Flapless Surgical Approach in the Treatment of Peri-implantitis

Universidad Complutense de Madrid1 个研究点 分布在 1 个国家目标入组 117 人开始时间: 2018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
入组人数
117
试验地点
1
主要终点
Disease resolution percentage

研究概览

简要总结

Aim: To evaluate the effectiveness of a flapless surgical approach in the treatment of peri-implantitis and to explore the factors influencing disease resolution.

Material and Methods: This case series involved patients with at least one implant diagnosed with peri-implantitis treated with a flapless surgical approach. Treatment consisted on mechanical debridement and chemical decontamination of the implant surface plus mucosal curettage combined with/without systemic antimicrobials and/or prostheses modification. Follow-up visits for supportive peri-implant care (SPIC) were scheduled at 6 and 12 weeks, and then every 3 months during the first 12 months. Clinical and radiographic parameters were assessed at baseline, 3 months and 12 months. Disease resolution defined as residual probing depths < 5 mm, ≤ 1 point of BOP, absence of suppuration and absence of progressive bone loss compared to pre-treatment bone levels was the main outcome variable. Multilevel regression analyses was used to identify predictors affecting the probability of disease resolution.

详细描述

INTRODUCTION

Peri-implant diseases, especially peri-implantitis, represent a growing public health problem due to their high prevalence and the associated consequences (implant and implant-supported prosthesis loss). In addition, given the complex histopathology and the accelerated pattern of disease progression, peri-implantitis is considered one of the most challenging biological complications to treat.

A step-by-step approach has been proposed in the Clinical Practice Guidelines to maintain healthy peri-implant tissues and to manage peri-implant diseases, recommending that the treatment of peri-implantitis should start with a non-surgical step. However, systematic reviews have shown limited predictability and conflicting results for non-surgical treatment , suggesting that clinical and patient-reported benefits remain to be proven. Consequently, surgical interventions are frequently recommended due to the advantage of gaining access to remove the biofilm from the implant surface. However, treatment success based on clinical and radiographic outcomes,, for patients enrolled in regular post-treatment supportive care, are within 33-75% at the implant level following non-reconstructive surgical protocols and 51-58% with surgical reconstructive therapy.

To compensate the limited access to the implant surface, recent studies are including the curettage as part of the non-surgical treatment with promising results. With this procedure the granulation tissue is removed from the peri-implant mucosa and, if extended, it can also detach the periosteum and obtain direct access to the crestal bone and the entire contaminated implant surface. Given the inability of the peri-implant connective tissue to separate the inflammatory cell infiltrate from the crestal bone, gaining access to this critical area with a low morbidity procedure may represent an interesting alternative treatment strategy. With this modification, the treatment may be considered a minimally invasive surgery, with clear advantages for the patient in comparison to conventional open flap surgical techniques. This treatment strategy, however, needs to be further studied.

The objective of this case series was to evaluate the effectiveness of a flapless surgical approach in patients with peri-implantitis in terms of disease resolution and to explore the involved factors after a follow-up of 12 months.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

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

  • > 18 years old
  • presence before treatment of at least one implant diagnosed with peri-implantitis following the case definition of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions, defined as probing pocket depth > 6 mm combined with bleeding on probing and/or suppuration and progressive bone loss in relation to the radiographic bone level assessment at 1 year following the delivery of the implant-supported prosthetics reconstruction. In the absence of initial radiographs, radiographic evidence of bone level ≥3 mm was considered; - follow-up period after treatment of at least 12 months

排除标准

  • pregnant or breast-feeding
  • had systemic contraindications to receive treatment
  • had presence of implant-supported removable overdentures
  • present implant mobility before treatment
  • present inability or unwillingness to give informed consent.

结局指标

主要结局

Disease resolution percentage

时间窗: 12 months, 60 months

Percentage of implants that achieve disease resolution, defined as:probing depths \< 5 mm + \< 1 point of bleeding on probing (BOP) + absence of suppuration and absence of progressive bone loss compared to pre-treatment bone levels

次要结局

  • bleeding on probing(baseline, 3 months, 12 months, 60 months)
  • recession(baseline, 3 months, 12 months, 60 months)
  • intra-bony defect width(Baseline, 12 months)
  • smoking habit(Baseline)
  • time since implant placement(Baseline)
  • prosthesis modification as part of the treatment(Baseline)
  • presence of keratinized mucosa(Baseline)
  • Abutment height(Baseline)
  • Age(Baseline)
  • potentially related systemic diseases(Baseline)
  • periodontally stable patient(Baseline)
  • Type of toothbrush(Baseline)
  • prosthesis material(Baseline)
  • suppuration(baseline, 3 months, 12 months, 60 months)
  • diagnosis of periodontitis(Baseline)
  • Probing deph(baseline, 3 months, 12 months, 60 months)
  • Bull mouth of plaque score(Baseline)
  • Implant site(Baseline)
  • Implant arch(Baseline)
  • Implant diameter(Baseline)
  • marginal bone levels(Baseline, 12 months)
  • vertical intra-bony defect depth(Baseline, 12 months)
  • Gender(Baseline)
  • stage of periodontitis(Baseline)
  • Type of prosthesis(Baseline)
  • Prosthesis retention(Baseline)
  • prosthesis removal during the treatment(Baseline)
  • presence of intermediate abutment(Baseline)
  • access to oral hygiene before treatment(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ana Carrillo de Albornoz

Flapless surgical approach in the treatment of peri-implantitis.

Universidad Complutense de Madrid

研究点 (1)

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