跳至主要内容
临床试验/NCT03051594
NCT03051594Unknown不适用

Reliability of Fluorescent Camera and Caries Detection Dye Versus the Visual Tactile Method in Determining Caries Excavation Endpoint Using Microbiological Assessment (Randomized Clinical Trial)

Cairo University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年2月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
20
试验地点
1
主要终点
bacterial count

研究概览

简要总结

  1. Three dentinal carious lesions will be chosen in this study and will be in the same patient.
  2. Using local anaesthesia and rubber dam, the operative field will disinfected with 1% hypochlorite, and the dentine lesions should be exposed with a high-speed diamond bur by removing covering enamel.
  3. Before the excavation dentine samples are collected for baseline bacteriological assessment .
  4. Excavation will be carried out using new slow speed round burs and hand excavators.
  5. The excavation end point of one cavity will be determined using visual tactile method. The two other cavities will be inspected with fluorescent camera or caries detector dye (CDD) methods to determine excavation endpoint respectively.
  6. After excavation, dentine samples from the three cavities will be collected using a sterile excavator for the bacteriological assessment.
  • Number of visits & follow up period: all procedures will be done at the same visit and there is no follow up period.

Direct benefit of the research to the human volunteer: to determine the excavation endpoint to ensure complete caries removal and prevent it's recurrence in the future.

Scientific value and social benefits: to reach the best method to determine the excavation endpoint.

Expected risk to the human subjects: the ordinary side effects associated with any restorative treatment and no of the study variable has side effect on the patient and in case of any side effect due to the restorative treatment, the participant will directly contact the operator.

详细描述

II.1. Study setting

This clinical study will be held in the Clinic of Conservative Dentistry Department, Faculty of Oral and Dental Medicine, Cairo University, Egypt. The researcher will bear ultimate responsibility for all activities associated with the conduct of a research project including recruitment of patients , explaining and performing the procedures to them.

II.2. Variables of the study:

A total of 20 patients will participate in the study. Each patient will have 3 carious teeth. Resulting in a total of 60 carious lesions.

II.3. Trial Description:

研究设计

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

盲法说明

The side to which interventions or control is assigned to will be recorded and all records of all patients will be kept with the main supervisor . The operator will not be blinded as the difference in application protocol of the restorative materials prohibited blinding of the operator; however, the patient, Statisticians and Outcome assessors will be blinded to the material assignment

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •Patients with at least three carious lesions .
  • •Males or Females.
  • •Good oral hygiene.
  • •Co-operative patients approving the trial.

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

visual tactile assessment

Active Comparator

dentine sample collection and then bacterial count by Digital colony counter, Agar diffusion test after visual tactile assessment.

干预措施: visual tactile assessment (Diagnostic Test)

caries detector dye

Active Comparator

dentine sample collection and then bacterial count by Digital colony counter, Agar diffusion test after after using caries detector dye to determine the excavation endpoint.

干预措施: caries detector dye (Other)

fluorescent camera

Experimental

dentine sample collection and then bacterial count by Digital colony counter, Agar diffusion test after after using fluorescent camera to determine the excavation endpoint.

干预措施: fluorescent camera (Device)

结局指标

主要结局

bacterial count

时间窗: an average of 1 year

will be done by Digital colony counter, Agar diffusion test

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

mohamed mohamed sabry mohamed

Resident at conservative department

Cairo University

研究点 (1)

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