Effectiveness of Teleorientation in Oral Hygiene During the COVID-19 Pandemic

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dental Caries in Children
• Intervention / Treatment: Other: Teleorientation and Tooth Brushing Orientation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Marília Goulardins; Phone Number: 11993155133; Email: m_goulardins@usp.br

Study Locations

• Brazil
  • Sao Paulo
    • Ribeirao Preto, Sao Paulo, Brazil, 14021-370
      • Recruiting
      • Marilia G Gomes
      • Contact: Marília Gr Gomes, Master; Phone Number: 11993155133; Email: m_goulardins@usp.br
      • Contact: Marília Goulardins; Phone Number: 55 11993155133; Email: m_goulardins@usp.br
      • Sub-Investigator: Andiara De Rossi, Doctor
      • Sub-Investigator: Fernanda S Liévana, Master
      • Sub-Investigator: Ana Paula D Moreno, Master
      • Sub-Investigator: Fernanda A Carrer, Doctor
      • Sub-Investigator: Mary Caroline S Macedo, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 10 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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 .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group Whatsapp; Will receive standardized brushing Teleorientation consultation through the Whatsapp communication platform	Other: Teleorientation and Tooth Brushing Orientation; Guide children in toothbrushing with a preventive purpose during the COVID-19 pandemic
Active Comparator: Group Vídeo for Health; You will receive a standardized brushing Teleorientation consultation through the V4H Platform, created specifically for Teleconsultations	Other: Teleorientation and Tooth Brushing Orientation; Guide children in toothbrushing with a preventive purpose during the COVID-19 pandemic
Active Comparator: Group de Orientação presencial; You will receive a standardized face-to-face brushing orientation consultation.	Other: Teleorientation and Tooth Brushing Orientation; Guide children in toothbrushing with a preventive purpose during the COVID-19 pandemic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Individual assessment of groups	Assess the children's visible plaque index individually by photo	1 month

Collaborators and Investigators

• Sponsor: University of Sao Paulo

Publications and helpful links

General Publications

• Lotto M, Strieder AP, Ayala Aguirre PE, Oliveira TM, Andrade Moreira Machado MA, Rios D, Cruvinel T. Parental-oriented educational mobile messages to aid in the control of early childhood caries in low socioeconomic children: A randomized controlled trial. J Dent. 2020 Oct;101:103456. doi: 10.1016/j.jdent.2020.103456. Epub 2020 Aug 20.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): July 9, 2021
• Study Completion (Anticipated): July 9, 2021

Study Registration Dates

• First Submitted: July 9, 2021
• First Submitted That Met QC Criteria: July 16, 2021
• First Posted (Actual): July 20, 2021

Study Record Updates

• Last Update Posted (Actual): July 20, 2021
• Last Update Submitted That Met QC Criteria: July 16, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: eHealth, mobile health
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; COVID-19; Dental Caries
• Other Study ID Numbers: CAAE 39685920.7.0000.5419

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Make the study visible to other researchers through the sharing link

Study Data/Documents

1. Informed Consent Form
   Information identifier: CAAE 39685920.7.0000.5419
   Information comments: Through this address it is possible to identify the information about acceptance by the ethics committee of Univerdade São Paulo and also the consent form

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No