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临床试验/NCT06730568
NCT06730568已完成不适用

Effect of Different Non-surgical Treatment Approaches of Peri-implantitis: a Multi-arm Randomized Controlled Clinical Trial

Yeditepe University1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2017年11月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
1
主要终点
Probable Pocket Depth

研究概览

简要总结

Peri-implantitis is a biofilm-associated pathological condition characterized by inflammation within the peri-implant mucosa, which leads to the progressive loss of the surrounding supporting bone tissue. The primary goal of managing peri-implantitis is to control the peri-implant biofilm and resolve inflammation. Nonsurgical treatment of peri-implantitis by submarginal mechanical instrumentation alone typically provides clinical improvements, particularly in non-advanced cases. However, to ensure surface decontamination and enhance treatment outcomes, alternative or adjunctive methods, such as systemic/local antibiotics, antiseptics, lasers, and air-abrasion systems, have been proposed.

Therefore, the null hypothesis (H0) of the present study is that no statistically significant difference would be detected in clinical inflammation signs among patients diagnosed with early-stage peri-implantitis after undergoing one of the following treatments: nonsurgical mechanical instrumentation alone, mechanical instrumentation plus chlorhexidine (CHX), mechanical instrumentation plus gaseous ozone, mechanical instrumentation plus glycine air polishing, or glycine air polishing alone.

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
是

入选标准

  • •the presence of at least one titanium implant with clinical and radiographic signs of initial to moderate peri-implantitis
  • •single-unit or partial restorations without overhangings
  • •absence of occlusal overload
  • •the presence of at least 2 mm of keratinized attached peri-implant mucosa
  • •periodontally healthy participants with a good level of oral hygiene

排除标准

  • •the presence of implant mobility
  • •systemic diseases (i.e. diabetes (HbA1c <7), osteoporosis, bisphosphonate medication) which could affect the outcome of treatment
  • •placement, and prosthetic loading of implants within the past year

研究组 & 干预措施

Mechanical Instrumentation (M)

Active Comparator

The participants in the mechanical instrumentation (M) group were treated with conventional submarginal instrumentation using titanium curettes.

干预措施: Submarginal mechanical instrumentation (Procedure)

Mechanical Instrumentation with Chlorhexidine (MC)

Experimental

Participants in the mechanical instrumentation with chlorhexidine (MC) group were treated with conventional submarginal instrumentation using titanium curettes followed by adjunctive chlorhexidine irrigation.

干预措施: Submarginal mechanical instrumentation and chlorhexidine irrigation (Procedure)

Mechanical Instrumentation with Ozone (MO)

Experimental

Participants in the mechanical instrumentation with chlorhexidine (MC) group were treated with conventional submarginal instrumentation using titanium curettes followed by gaseous ozone

干预措施: Submarginal mechanical instrumentation and ozone application (Procedure)

Mechanical Instrumentation with Air Abrasion (MA)

Experimental

The participants in the mechanical instrumentation with glycine powder air abrasion (MA) group were treated with conventional submarginal instrumentation using titanium curettes and followed by adjunctive glycine air-abrasion.

干预措施: Submarginal mechanical instrumentation and air abrasion (Procedure)

Air Abrasion Monotherapy (A)

Experimental

The participants in the air abrasion monotherapy (A) group were treated exclusively with glycine powder-based air abrasion.

干预措施: Air abrasion monotherapy (Procedure)

结局指标

主要结局

Probable Pocket Depth

时间窗: Baseline, 3 months, and 6 months after treatment

次要结局

  • Bleeding on Probing(Baseline, 3 months, and 6 months after treatment)
  • Plaque Index(Baseline, 3 months, and 6 months after treatment)

研究者

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

Nihal ERAYDIN

Assistant Professor

Yeditepe University

研究点 (1)

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