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

Dental Caries in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04967794
• Other study ID #: CAAE 39685920.7.0000.5419
• Status: Recruiting
• Phase: Early Phase 1
• Start date: June 1, 2021
• Est. completion date: July 9, 2021

Study information

• Verified date: July 2021
• Source: University of Sao Paulo
• Contact: Marília Goulardins
• Phone: 11993155133
• Email: m_goulardins[@]usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 9, 2021
• Est. primary completion date: July 9, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 10 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries in Children

Intervention

Other:
• Teleorientation and Tooth Brushing Orientation
Guide children in toothbrushing with a preventive purpose during the COVID-19 pandemic

Locations

Country	Name	City	State
Brazil	Marilia G Gomes	Ribeirao Preto	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Individual assessment of groups	Assess the children's visible plaque index individually by photo	1 month