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临床试验/NCT03114956
NCT03114956撤回不适用

Effects of Implant Surface Decontamination on Control of Peri-Implant Inflammation

University of Southern California0 个研究点开始时间: 2019年6月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
主要终点
Bleeding on Probing (BOP)

研究概览

简要总结

Peri-implantitis represents a major biological complication of implant dentistry with reported prevalence of up to 47% of implants. The disease is characterized by inflammatory response to the biofilm inhabiting the implant surface. To treat this inflammatory disease, surgical and non-surgical therapies have been proposed, all of which entail biofilm removal through implant surface decontamination. Systematic review of various surface decontamination protocols has failed to demonstrate superiority of any of the protocols. One possible explanation is that most studies have examined decontamination of implant surfaces following experimentally-induced peri-implantitis, where implant surfaces lack the tenacious mineralized biofilm often found in clinical peri-implantitis and are therefore easily decontaminated.

The investigators have hypothesized that control of inflammation and repair of pathologically damaged peri-implant tissues requires a comprehensive mechanical plus chemical surface decontamination therapy. The aims of this study are to 1) determine the most effective surface decontamination protocol that can lead to control of peri-implant inflammation and 2) delineate the microbial and immunological mediators that are associated with the changes in peri-implant inflammation. The investigators propose to compare conventional implant surface contamination techniques to a comprehensive mechanical plus chemical protocol. This randomized controlled clinical trial seeks to enroll 68 participants with at least one implant diagnosed with moderate to severe peri-implantitis. Pre-op parameters to be assessed include: probing pocket depth, bleeding on probing, suppuration, plaque index, marginal inflammation, recession, clinical attachment level, inflammatory biomarkers and microbial sampling, and digital intra-oral peri-apical radiograph. Subjects will be randomly assigned to one of the four surgical debridement intervention groups: (A) gauzes soaked in sterile saline and chlorhexidine; (B) Titanium brush; (C) Air power abrasion; (D) comprehensive surface decontamination, including titanium brush, air powder abrasion and surface etching with 9.6% hydrofluoric acid gel. At 3-months post-operative, the initial clinical assessment will be repeated. The clinical examination will be used to analyze the efficacy of each treatment in controlling peri-implant mucosal inflammation. The ultimate objective of this research is not only to identify an effective method for control of peri-implant inflammation, but also to lay the foundation to detect biomarkers of peri-implantitis that can potentially be helpful in future studies as risk factors of this disease.

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)

盲法说明

The investigator who is analyzing the data will be blinded to the assigned groups to prevent bias.

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • PPD >6 mm
  • Positive BOP
  • Peri-implant marginal bone loss (MBL) >3 mm
  • Age: 18 to 75 years
  • Exclusion Criteria
  • Implant mobility
  • Current cancer
  • Steroids use (last 2 years)
  • Bisphosphonates use (last 4 years)
  • Uncontrolled diabetes (HBA1c >7)
  • Other systemic conditions that affect wound healing

排除标准

  • 未提供

研究组 & 干预措施

Group A

Experimental

Implant surface will be wiped with sterile gauze soaked alternatively in sterile saline and CHX (5 times)

干预措施: Gauze (Procedure)

Group B

Experimental

Titanium brush: Titanium brush (TiBrush, Straumann, Switzerland) mounted on an oscillating hand piece will be used for 1 minute.

干预措施: Titanium brush (Procedure)

Group C

Experimental

Air powder abrasion: One minute of air powder abrasion using Glycine prophy powder (Prophy Jet, Dentsply, USA) with overlapping passes form apical to coronal direction for 1 minute.

干预措施: Air powder abrasion (Procedure)

Group D

Experimental

A comprehensive treatment including the use of titanium brush and air powder abrasion (as described above) and 30 seconds etching with 9.6% HF acid gel (Premier, USA) applied with a micro-applicator tip (Unipack Medical, USA), followed by copious irrigation with sterile saline.

干预措施: Comprehensive (Procedure)

结局指标

主要结局

Bleeding on Probing (BOP)

时间窗: 3 months

A periodontal probe will be used at 6 locations around each implant (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, and distolingual). Presence of gingival bleeding upon probing will be recorded. This will be a binary outcome (Yes or No)

Suppuration upon probing

时间窗: 3 months

A periodontal probe will be used at 6 locations around each implant (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, and distolingual). Presence of suppuration upon probing will be recorded. This will be a binary outcome (Yes or No)

Probing Pocket Depth (PPD)

时间窗: 3 months

Distance from the gingival margin to the depth of the pocket

次要结局

  • Marginal bone loss(3 month)
  • Inflammatory biomarkers(3 months)
  • Microbial profile(3 months)

研究者

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

Neema Bakhshalian

Assistant Professor

University of Southern California

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