跳至主要内容
临床试验/NCT03362307
NCT03362307已完成不适用

Use Low-Level Laser and Light-Emitting Diodes in Dental Implants

Shiraz University of Medical Sciences0 个研究点目标入组 28 人开始时间: 2014年1月1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
28
主要终点
Resonance frequency analysis

研究概览

简要总结

Subjects were assigned in two groups: In group 1, subjects received LLL and LED 20 min/day for 10 days after implant insertion, subjects in group 2did not undergo LLL and LED. implant stability quotients(ISQs) were measured in 0,10,21,42 and 63 days after implant placement.

详细描述

Subjects eligible for study inclusion had an edentulous area at the first molar of the mandible and needed a dental implant. Subjects were excluded from study enrollment if they had any diseases that affect bone, smoking, insufficient bone in the edentulous area which needs bone augmentation, failed to return for follow-up, or refused study enrollment.

All implants were placed at least 3 months after tooth removal. The size of implants was 4.8X 10 mm (Zimmer, USA) Subjects were aligned based on computer randomization in two groups: In group 1(intervention), subjects received LLL and LED after implant placement and in group 2 (control) the same device was used while device was off.

A portable device was applied for irradiation of the intervention group with combination of 810nm laser and 632nm LED.

Subjects in group 1 underwent LLL 15 mw/cm2 and LED 10 mw/cm2 20 min every day for 10 days.

The mesiodistal and buccolingual directions were measured and the mean implant stability quotients (ISQs) were determined. The RFA measurements were performed in immediate after insertion (time0) 10 days (time1), 3 weeks (time2), 6 weeks(time3) and 9(time 4) weeks after implant placement.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

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

  • subjects eligible for study inclusion had an edentulous area at the first molar of the mandible and needed a dental implant

排除标准

  • . Subjects were excluded from study enrollment if they had any diseases that affect bone, smoking, insufficient bone in the edentulous area which needs bone augmentation, failed to return for follow-up, or refused study enrollment.

研究组 & 干预措施

Laser Emitting group

Active Comparator

subjects received Low-Level Laser and Light-Emitting Diodes after implant placement

干预措施: Low-Level Laser and Light-Emitting Diodes (Device)

Laser Emitting group

Active Comparator

subjects received Low-Level Laser and Light-Emitting Diodes after implant placement

干预措施: Dental implant placement (Device)

Non Emitting group

Placebo Comparator

In laser emitiiing group, subjects received Low-Level Laser and Light-Emitting Diodes after implant placement and in Non-emitting group,the same device was used while device was off.

干预措施: Low-Level Laser and Light-Emitting Diodes (Device)

Non Emitting group

Placebo Comparator

In laser emitiiing group, subjects received Low-Level Laser and Light-Emitting Diodes after implant placement and in Non-emitting group,the same device was used while device was off.

干预措施: Dental implant placement (Device)

结局指标

主要结局

Resonance frequency analysis

时间窗: Nine weeks after implant placement(time 4)

The stability of the implants was evaluated with resonance frequency analysis by the Osstell device

次要结局

未报告次要终点

研究者

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

Reza Tabrizi

associate Professor

Shiraz University of Medical Sciences

相似试验