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

Primary Purpose

Dental Caries in Children

Status

Unknown status

Phase

Early Phase 1

Locations

Brazil

Study Type

Interventional

Intervention

Teleorientation and Tooth Brushing Orientation

About this trial

This is an interventional prevention trial for Dental Caries in Children focused on measuring eHealth, mobile health

Eligibility Criteria

6 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

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 .

Sites / Locations

Marilia G GomesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Group Whatsapp

Group Vídeo for Health

Group de Orientação presencial

Arm Description

Will receive standardized brushing Teleorientation consultation through the Whatsapp communication platform

You will receive a standardized brushing Teleorientation consultation through the V4H Platform, created specifically for Teleconsultations

You will receive a standardized face-to-face brushing orientation consultation.

Outcomes

Primary Outcome Measures

Individual assessment of groups

Assess the children's visible plaque index individually by photo

Secondary Outcome Measures

Full Information

NCT ID

NCT04967794

First Posted

July 9, 2021

Last Updated

July 16, 2021

Sponsor

University of Sao Paulo

1. Study Identification

Unique Protocol Identification Number

NCT04967794

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Unknown status

Study Start Date

June 1, 2021 (Actual)

Primary Completion Date

July 9, 2021 (Actual)

Study Completion Date

July 9, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Caries in Children

Keywords

eHealth, mobile health

7. Study Design

Primary Purpose

Prevention

Study Phase

Early Phase 1

Interventional Study Model

Crossover Assignment

Model Description

The study population will be divided into three groups that will receive the intervention by communication platform, teleconsultation platform in health and in person.all individuals participating in the group will receive toothbrushing guidelines as a preventive measure for the development of dental caries

Masking

Participant

Masking Description

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

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group Whatsapp

Arm Type

Active Comparator

Arm Description

Will receive standardized brushing Teleorientation consultation through the Whatsapp communication platform

Arm Title

Group Vídeo for Health

Arm Type

Active Comparator

Arm Description

You will receive a standardized brushing Teleorientation consultation through the V4H Platform, created specifically for Teleconsultations

Arm Title

Group de Orientação presencial

Arm Type

Active Comparator

Arm Description

You will receive a standardized face-to-face brushing orientation consultation.

Intervention Type

Other

Intervention Name(s)

Teleorientation and Tooth Brushing Orientation

Intervention Description

Guide children in toothbrushing with a preventive purpose during the COVID-19 pandemic

Primary Outcome Measure Information:

Title

Individual assessment of groups

Description

Assess the children's visible plaque index individually by photo

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

10 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 .

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marília Goulardins

Phone

11993155133

m_goulardins@usp.br

Facility Information:

Facility Name

Marilia G Gomes

City

Ribeirao Preto

State/Province

Sao Paulo

ZIP/Postal Code

14021-370

Country

Brazil

Individual Site Status

Recruiting

Facility Contact: