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临床试验/NCT03819075
NCT03819075招募中不适用

An Evaluation Of Effectiveness Of A Combined Er:YAG And Nd:YAG Laser Protocol For Treatment Of Peri-Implantitis: A Randomized Controlled Trial

Luis Monteiro2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2018年3月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
62
试验地点
2
主要终点
Proportion of participants with treatment success

研究概览

简要总结

A laser treatment for periimplantitis using two different wavelengths (Er:YAG and Nd:YAG) will be compared to standard treatment in a randomized clinical trial.

详细描述

The general aim of this study is to evaluate the clinical outcome of the treatment of peri-implantitis using a combination of a Er:YAG and Nd:YAG laser protocol or using a conventional mechanical treatment in patients with a diagnosis of peri-implantitis.

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

Clinical measurements will be performed by an evaluator unaware of group assignment.

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

  • at least one implant with peri-implantitis
  • no serious mobility of the implants
  • written informed consent of the voluntary participant in the study
  • availability of participant for control visits for a follow-up of at least 12 months without interruptions

排除标准

  • serious systematic disease
  • pregnancy
  • current use of photosensitive drugs, bisphosphonate medication or antibiotics
  • patients who do not want to follow post treatment recommendation of oral hygiene and follow-up visits

结局指标

主要结局

Proportion of participants with treatment success

时间窗: 6 months

Treatment success defined as implant survival with the absence of peri-implant probing depths (PD) greater than 5 mm with concomitant bleeding/suppuration and absence of progression of peri-implant bone loss.

次要结局

  • Bleeding on probing(12 months)
  • Mucosal recession(12 months)
  • Plaque index(12 months)
  • Probing depth(12 months)
  • Clinical attachment level gain(12 months)
  • Quality of life questionnaire(12 months)

研究者

发起方
Luis Monteiro
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Luis Monteiro

DMD, Phd, Auxiliar Professor at the IUCS in Periodontal Surgical Clinic, Oral Pathology and Biopathology

Cooperativa de Ensino Superior, Politécnico e Universitário

研究点 (2)

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