跳至主要内容
临床试验/NCT04847648
NCT04847648Enrolling By Invitation不适用

Air-polishing in the Treatment of Peri-implantitis - a Randomized Controlled Trial

Göteborg University3 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年10月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
80
试验地点
3
主要终点
Proportion of participants/implants displaying pocket closure

研究概览

简要总结

The aim of the present study is to evaluate the potential benefit of the adjunctive use of an air-polishing device in the non-surgical treatment of peri-implantitis as compared to mechanical infection control alone. Following establishment of adequate patient-performed infection control, 80 patients diagnosed with moderate/severe peri-implantitis at ≥1 implant will be randomized to one of two groups. Non-surgical will be carried out by experienced operators in three clinical centers and the mechanical instrumentation (control group) will be supplemented by the use of air-polishing with erythritol powder (AirFlow Master, EMS, Nyon, Switzerland) in the test group. The primary outcome assessed is "pocket closure" (ie probing pocket depth ≤5 mm & absence of profuse bleeding on probing) after 6 months. Secondary outcomes include changes of clinical signs of soft tissue inflammation, adverse events and patient-reported outcome measures. Outcomes of non-surgical therapy will be evaluated at 3 and 6 months. Sites with remaining pathology at 6 months will be subjected to surgical therapy. Patients are then provided with personalized maintenance care and followed up to a 5-year evaluation.

详细描述

The project will be conducted as a two-armed randomized controlled clinical trial of 5-year duration in three clinical centers. 80 systemically healthy patients diagnosed with moderate/severe peri-implantitis at ≥1 implant will be enrolled.

Upon enrolment, all patients will receive instructions in oral hygiene measures until adequate plaque control has been established (Plaque Index ≤20%). If required, supraconstructions will be adjusted to facilitate adequate oral hygiene measures. Thereafter, study participants will be randomized into two groups, stratified for smoking (yes/no) and number of implants in need of treatment (single/multiple).

The control group will be subjected to professionally administered non-surgical, mechanical infection control including the use of hand instruments and polishing cups aiming at the removal of all supra-mucosal soft and hard deposits from the target sites. In the test group the aforementioned treatment will be supplemented by the use of an air-polishing device (AirFlow Master, EMS, Nyon, Switzerland) with a specially designed nozzle for sub-mucosal application (PerioFlow Handpiece, EMS, Nyon, Switzerland). Following local anesthesia, the instrument will be used sub-mucosally at all aspects (ie mesial, distal, buccal, lingual) of the affected implant(s) at a power setting reduced to 60% and with a erythritol powder (14 mikrometer, AirFlow Plus Powder, EMS, Nyon, Switzerland). The handpiece will be guided in a circular motion in a corono-apical direction not in contact with the implant surface. Instrumentation time will be limited to 5 seconds at each aspect. Implant-supported supraconstructions will not be removed for the non-surgical treatment. Patients are recalled two weeks later for assessment of patient-experienced outcomes, professional supramucosal cleaning and reinforcement of oral hygiene.

Peri-implant soft tissues will be evaluated at three months. Implant sites with remaining signs of pathology (PPD ≥6 mm and presence of BOP at ≥3 aspects per implant will be subjected to re-treatment according to the initial allocation. The clinical evaluation will be repeated at 6 months. In case of residual signs of pathology, affected sites will be subjected to surgical therapy of peri-implantitis within the subsequent 4 weeks. Full thickness flaps will be elevated and inflamed tissues will be removed. Mineralized deposits on the implant surfaces will be removed with titanium-coated curettes. Surface decontamination will be performed using a rotating titanium brush under irrigation with saline. No bone recontouring of bony walls is intended. Flaps will be sutured to the level of the bone and sutures will be removed after 2 weeks. Implant-supported supraconstructions will be removed for the surgical intervention, if possible.

Maintenance therapy will be provided at 9 and 12 months and based on individual needs during the subsequent follow-up. A renewed evaluation will be performed at 12 and 18 months. Long-term assessments will be carried out annually from years 3 to 5. Should any implant site present with signs of disease progression (increase of PPD >2 mm and additional bone loss >1 mm compared to baseline) at any of the follow-up examinations, the implant will be exited from the study and appropriate additional therapy will be provided.

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

Clinical assessments will be performed by assessors unaware of group allocation. Bone level changes over time will be assessed on radiographs and expressed in mm by examiners blinded to group 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

  • Probing pocket depth of ≥6 mm
  • Bleeding and/or suppuration on probing at ≥3 aspects per implant
  • Documented radiographic bone loss of ≥2 mm.

排除标准

  • Implants with bone loss ≥80% of implant length will not be considered.
  • No medical conditions prohibiting non-surgical/surgical treatment of peri-implantitis
  • Implant(s) in function ≥1 year

研究组 & 干预措施

Test - Mechanical instrumentation and air-polishing of implant surface

Experimental

In the test group the mechanical instrumentation will be supplemented by the use of an air-polishing device during non-surgical therapy.

干预措施: Mechanical decontamination (Procedure)

Control - Mechanical instrumentation of implant surface

Active Comparator

The control group will be subjected to non-surgical decontamination including the use of hand instruments and polishing cups aiming at the removal of all supra-mucosal soft and hard deposits from the implant surfaces.

干预措施: Mechanical decontamination (Procedure)

Test - Mechanical instrumentation and air-polishing of implant surface

Experimental

In the test group the mechanical instrumentation will be supplemented by the use of an air-polishing device during non-surgical therapy.

干预措施: Air-polishing (Procedure)

结局指标

主要结局

Proportion of participants/implants displaying pocket closure

时间窗: 18 months

Pocket closure: Probing pocket depth of ≤5 mm and absence of bleeding on probing at ≥3 aspects per implant and absence of suppuration on probing

Patient satisfaction assessed by visual analogue scale

时间窗: 18 months

Patient satisfaction as assessed on a 100 mm VAS

次要结局

  • Rate of adverse events(18 months)
  • Changes in probing pocket depth(5 years)
  • Changes in bleeding on probing(5 years)
  • Changes in marginal soft soft tissue levels(5 years)
  • Changes in radiographic bone levels(5 years)
  • Patient discomfort as expressed on a visual analogue scale(6.5 months)
  • Esthetic appreciation as expressed on a visual analogue scale(18 months)

研究者

发起方
Göteborg University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jan Derks

Associate Professor

Göteborg University

研究点 (3)

Loading locations...

相似试验