跳至主要内容
临床试验/NCT03298165
NCT03298165Unknown不适用

Diode Laser Cavity Disinfection (A Six Month Randomized Clinical Trial).

Cairo University0 个研究点目标入组 15 人开始时间: 2018年2月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
15
主要终点
bacteriological count

研究概览

简要总结

This study will be conducted to assess antibacterial effect of the diode laser in deep carious cavity after step wise excavation using the bacteriological assessment method.

详细描述

each patient should have at least two deep carious lesions The first clinical step in all teeth will be the opening of the cavity and the removal of undermined enamel . Caries at the lateral walls of the cavity and at the enamel-dentin junction was completely removed with excavators and/or round carbide burs at low speed. Subsequently, the central cariogenic biomasses and superficial part of the necrotic and demineralized dentin were removed. then excavation continued until the pulp exposure would occur with further excavation; thus, a layer of soft carious dentin was left on the cavity floor adjacent to the pulp wall.

A dentine samples will be then collected from the base of the cavity using sterile spoon excavator from the both groups for baseline bacteriological assessment and another sample will be taken after disinfection with diode laser in the intervention group .

In the two groups The remaining innermost layer of carious dentin are covered with calcium hydroxide The cavity was then sealed with restorative material (resin modified glass ionomer) after a 6 month period. This time was considered adequate for calcium hydroxide to exert its effect and for the pulp to respond with possible formation of tertiary dentin. The teeth were followed up every month and the integrity of the temporary restoration checked. After this interval of 6 months. After the rubber dam application, the temporary filling is removed samples are collected and the teeth are finally restored

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

outcome assessor the assessor will not be blind about the type of intervention/control assessment methods. however it will not be allowed amongst the examiners to exchange any information throughout the entire study period

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with at least two deep occlusal carious lesion .
  • 18 - 25years.
  • Males or Females.
  • Good oral hygiene.
  • Co-operative patients approving the trial and willing to sign a written consent.

排除标准

  • Systemic disease or severe medical complications.
  • Heavy smoking.
  • Xerostomia.
  • Lack of compliance.
  • Evidence of temporomandibular joint disorders.

研究组 & 干预措施

disinfection the cavity with diode laser

Experimental

diode laser has antibacterial effect so can disinfect deep cavity and decrease the count of bacteria present after stepwise excavation

干预措施: diode laser (Device)

no cavity disinfection

Placebo Comparator

placebo is used as no cavity disinfection will be done as after excavation the restoration will be placed .

干预措施: diode laser (Device)

结局指标

主要结局

bacteriological count

时间窗: 30 minute

dentine samples will be taken before and after application of diode laser then bacteriological assessment will be done in the micro-lab

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

shahenda gamal tawfik hamdy

internal resident

Cairo University

相似试验