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临床试验/NCT04967794
NCT04967794Unknown早期 1 期

Effectiveness of Teleorientation in Oral Hygiene During the COVID-19 Pandemic, a Randomized Clinical Trial

University of Sao Paulo2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
早期 1 期
入组人数
30
试验地点
2
主要终点
Individual assessment of groups

研究概览

简要总结

The present study aims to evaluate the effectiveness of Teleorientation in oral hygiene during Pandemic by COVID-19 in children aged 6 to 10 years, attended at the Pediatric Clinic of Forp. For this, a randomized clinical study will be carried out with the factor to be analyzed the comparison between synchronous and asynchronous teleorientation, the effectiveness of the transfer of knowledge in oral hygiene through video modeling and remote guidance. The response variables will be the assimilation of oral hygiene guidance through video modeling and synchronous guidance, the hypothesis is that educational content will have beneficial effects on children's oral health.

详细描述

This is a randomized clinical trial, whose sample is composed of thirty children aged 6 to 10 years, attended between the year 2019 and the beginning of 2020. The sample will be randomly randomized into 3 groups who received guidance on toothbrushing. group 1 will be done Teleorientation of tooth brushing through video call by the Whatsapp application, in group 2 will be done Teleorientation of toothbrushing through a platform designed exclusively for teleconsultations and group 3 will receive the same in-person brushing orientation.

The main purpose of the clinical trial is to develop and analyze a program of Teleorientation of Toothbrushing in children of the Pediatric Dentistry clinic of FORP.

The Specific Objectives are assess whether oral hygiene is taking place properly during the COVID-19 Pandemic, assess, through a questionnaire, the level of understanding of parents and caregivers regarding the information received. This project will be designed as a randomized study with a two-month follow-up. The study factor will be to compare synchronous with asynchronous teleorientation, the effectiveness of knowledge transfer in oral hygiene through video modeling and remote orientation. The response variables will be the assimilation of guidance in oral hygiene by video modeling and by synchronous guidance, the hypothesis is that educational content will have beneficial effects on the oral health of children. The procedures will be performed at the Pediatric Dentistry Clinic of the Faculty of Dentistry of Ribeirão Preto - University of São Paulo - FORP/USP. The CONSORT guide (Schulz et al., 2010) for randomized controlled trials will be followed for the design of the present study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Participant)

盲法说明

The clinical trial is a simple blind study in which the sample will be randomized into three groups, whose participants will be "blinded" to the types of intervention

入排标准

年龄范围
6 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • children aged 6 to 8 years old,
  • attended at Forp's Pediatric Dentistry Clinic,
  • with complete record in the medical record,
  • parents or caregivers who have Smartphone and Internet access
  • and who are willing to download the V4H and
  • WhatsApp application and
  • accept to participate in all stages of the research upon acceptance of the consent form.
  • Exclusion Criteria
  • :Children who present pain and/or spontaneous sensitivity,
  • motor difficulties and
  • health disorders .

排除标准

  • 未提供

结局指标

主要结局

Individual assessment of groups

时间窗: 1 month

Assess the children's visible plaque index individually by photo

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

Marília Goulardins

Master's student in Pediatric Dentistry

University of Sao Paulo

研究点 (2)

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