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临床试验/NCT07044245
NCT07044245已完成不适用

Evaluation of the Effect of Low Level Diode Laser Biostimulation on Implant Stability in Immediate Implant in The Maxillary Premolars. A Randomized Clinical Trial.

Alexandria University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年11月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Implant Stability Assessment using Radio frequency analysis

研究概览

简要总结

Tooth loss is accompanied by bone loss in all dimensions, so preservation of the bone is mandatory for placement of dental implant, as bone quantity and quality are predictive factors in achieving proper primary stability. Low level bio stimulation has stimulatory effect on bone cells so it can be used in immediate implants to increase bone formation around the implant.

the Aim of this study is to evaluate the effect of low-level diode laser Biostimulation on immediate implants in maxillary premolars.

详细描述

20 patients with unrestorable maxillary premolars were included in the study treated with immediate implants. Patients were divided into two groups (n=10). Group 1 Received immediate implant with low level diode laser application (study), and group 2 received immediate implant without laser application (control). Preoperative clinical and radiographic evaluation, immediate post operative and after 4 months radiographic evaluation to assess stability and bone density around the implant.

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, Outcomes Assessor)

盲法说明

Sequentially numbered, opaque, sealed envelopes (SNOSE) allocation concealment method will be utilized. Each participant included in the study will be given a serial number that will be used in the allocation. These numbers will be written in identical sheets of paper with the group to which each participant is allocated and placed inside opaque envelopes carrying the respective names of participants. A trial independent personnel will be assigned the role of keeping the envelopes and unfolding them only at the time of the operation, so that the participant is allocated to a group which is concealed from the operator Furthermore, outcome assessor was blinded from the group enrollment

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

  • Patients with unrestorable maxillary premolars with sufficient bone quantity to receive the dental implant.
  • Age ranging from 25-
  • Patients with no local or systemic pathology that can interfere with normal wound healing.
  • Non- smokers.
  • Patients that are properly motivated to complete follow up visits.
  • Patients with adequate oral hygiene or willing to improve their oral hygiene to ensure uncompromised wound healing.

排除标准

  • Patients with uncontrolled medical condition that can affect surgical outcome or bone and wound healing. (ex: diabetes mellitus)
  • Patients with periapical pathology that may contraindicate immediate implant placement.
  • History of receiving irradiation in head and neck region

结局指标

主要结局

Implant Stability Assessment using Radio frequency analysis

时间窗: 4 month

Secondary implant stability analysis was performed 4-months after implant placement. Radio frequency analysis (RFA) was performed using Osstell device (Integration diagnostic Ltd. Company, Sävedalen, Sweden). Primary and secondary implant stability were analyzed and compared. The use of the Osstell and ISQ values were obtained by a blinded operator

次要结局

  • Radiographic assessment of the management of the crestal bone width and changes in labial bone thickness.(4 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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