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临床试验/NCT04495335
NCT04495335Unknown不适用

The Effect of Photobiomodulation Application on Implant Stabilization and Peri-implant Microbiology

T.C. Dumlupınar Üniversitesi2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
90
试验地点
2
主要终点
primary and secondary implant stability

研究概览

简要总结

Objective: The aim of the present study was to address the following questions: does photobiomodulation therapy (PBMT) improve implant stability and affect microbiota around dental implants in the early stage of osseointegration.

Material and Methods: Implants will randomly be divided into two groups and implants will be placed in the test group treating with Gallium-aluminum-arsenate (GaA1As) diode laser with photobiomodulation therapy immediately after surgery and for 15 days. In the control group, implants are not irradiated. The primary stability of the implants will measure by the Resonance frequency analysis (RFA) after insertion and the secondary stability values will record at 30th, 60th, and 90th days after surgery as implant stability quotient (ISQ). Plaque samples will collect for microbiological analyzes at the first 24 hours after implant surgery and six days after 90 days at six sterile endodontic paper points.

详细描述

The same surgical procedure will be operated in the test and control groups by the same surgeon. Full-thickness flaps were raised and dental implant osteotomy preparation will be completed according to the manufacturers' instructions. Laser treatment will be completed using Gallium-Aluminum-Arsenide diode laser. The photobiomodulation application will v-be completed by laser energy immediately and three times a week for just 15 days after surgery. The control group will consist of laser application without energy delivery to the tissue. Immediately after implant placement, the third generation stability resonance frequency (RF) analyzer will be applied for direct measurement of implant stability and the value will be recorded. The microbiological plaque samples will be collected at specific times, according to the following schedule; at the first 24-hour and 90 days after implant surgery. All bacterial DNA specimen will be analyzed with qPCR technique to evaluate Aggregatibacter actinomycetemcomitans (Aa), Porphyromonas gingivalis (Pg), Prevotella intermedia (Pi) , Tannerella forsythia (Tf ) and total amount of bacteria.

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 (Participant, Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • at least one tooth loss in left and right posterior sides of upper and lower jaws
  • adequate alveolar bone volume as horizontal and vertical

排除标准

  • uncontrolled systemic diseases
  • parafunctional (bruxism and/or clenching)
  • smoking habits
  • any allergies or metabolic bone diseases,
  • pregnancy
  • surgical periodontal treatment in 6 months
  • using antibiotics in the last 6 months

结局指标

主要结局

primary and secondary implant stability

时间窗: The stability was measured at 90 days postoperatively.

Immediately after implant placement, the third generation stability resonance frequency (RF) analyzer (Osstell ISQ, Integration Diagnostics AB, Gamlestadsvägen, Goteborg, Sweden) was applied for direct measurement of implant stability and the value was recorded.

次要结局

  • Evaluation of the number of peri-implant total microorganisms by PCR(Microbiological samples will obtained at the 90 days after implant surgery)

研究者

发起方
T.C. Dumlupınar Üniversitesi
申办方类型
Other
责任方
Principal Investigator
主要研究者

Berceste Guler

DDS PhD, Assist Prof

T.C. Dumlupınar Üniversitesi

研究点 (2)

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