跳至主要内容
临床试验/NCT05733234
NCT05733234已完成不适用

Lasers in Peri-implantitis Treatment YAG and Er: YAG Laser Approach, Investigation of Clinical and Bone Loss Biomarkers

Aristotle University Of Thessaloniki1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年5月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Probing Pocket Depth

研究概览

简要总结

The current study aimed to investigate the effect of the combined Nd-Er: YAG laser on the surgical treatment of peri-implantitis by evaluating clinical markers and biomarkers of bone loss (RANKL/OPG). Twenty (20) patients having at least 1 implant diagnosed with peri-implantitis were randomly assigned to two groups for surgical treatment. In the test group (n=10), Er: YAG laser was used for granulation tissue removal and implant surface decontamination, while Nd: YAG laser was employed for deep tissue decontamination and biomodulation. In the control group (n=10), an access flap was applied, and mechanical instrumentation of the implant surface was performed by using titanium curettes. The following clinical parameters were evaluated at baseline and six months after treatment: Full-mouth Plaque Score (FMPS), Probing Pocket Depth (PPD), Probing Attachment Levels (PAL), recession (REC), and Bleeding on probing (BoP). Peri-implant crevicular fluid (PICF) was collected at baseline and six months for the evaluation of soluble RANKL and OPG utilizing enzyme-linked immunosorbent assay (ELISA).

详细描述

The study was designed as a prospective, randomized, controlled trial of a 6-month duration. Participants were recruited from the Department of Periodontology and Implant Biology of the Dental Faculty, School of Health Sciences, Aristotle University of Thessaloniki. Patients participating in this study should have at least one implant diagnosed with peri-implantitis according to the 2017 world Workshop on Periodontology definition.

The two groups were the control group (C group), where surgical peri-implantitis therapy was performed with the use of an access flap and mechanical instrumentation of the contaminated implant surface. In the test group (Laser group), surgical treatment was carried out with the conjunctional use of laser irradiation of the contaminated implant surface.

In order to assess peri-implant osseous defect depth, a radiographic examination was performed at baseline.

The assignment of patients into the two groups of the study was succeeded by a randomization process with the use of computer software (www.randomizer.org). In patients with more than one implant having peri-implantitis, a second randomization procedure with the same procedure determined which implant would be included. The randomization results were placed in opaque envelopes accessible only by the supervisor (I.V.) and given to the treating investigator for each patient, just prior to therapeutic intervention. The present research study was approved by the Ethics Committee of the School of Dentistry. Protocol No. 83/15-06-2020. All participants received written information regarding the aim and the procedures of the study, and afterwards, they were asked to sign their consent.

Sample size calculation was performed on a patient-based analysis in order to detect a clinically significant difference in probing pocket depth (PPD) of 1mm±0.75 mm SD between the two groups (control and laser). Type I error was set at 0.05 level and power at 0.80. The minimum required sample size was calculated to be ten patients per group. In addition, in order to detect a clinically significant difference in PPD of 1mm±1mm SD between the two time periods, within the group, with 0.05 type I error and 0.80 power, the minimum required sample size was estimated to be ten patients per group too.

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

性别
Male
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Test

Experimental

Laser-assisted surgical treatment of peri-implantitis

干预措施: Laser ,Fotona, Light Walker AT, Ljubljana, Slovenia (Device)

Control

Active Comparator

Surgical treatment of peri-implantitis - No laser

干预措施: Mechanical Treatment (Drug)

结局指标

主要结局

Probing Pocket Depth

时间窗: 6 months

Clinical Periodontal Marker PPD: the distance from the mucosa margin to the bottom of the peri-implant pocket in mm, measured with a periodontal probe

次要结局

  • Bleeding On Probing(6 months)
  • Probing Attachment Levels(6 months)
  • Bone loss Biomarkers RANKL/OPG(6 months)

研究者

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

Ioannis Fragkioudakis

Principal Investigator

Aristotle University Of Thessaloniki

研究点 (1)

Loading locations...

相似试验