Dental Caries in ChildrenEarly Phase 1NCT04967794
Effectiveness of Teleorientation in Oral Hygiene During the COVID-19 Pandemic
A Early Phase 1 study testing Teleorientation and Tooth Brushing Orientation in people with Dental Caries in Children, run by University of Sao Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Children
- What is being tested?
- Teleorientation and Tooth Brushing Orientation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2021to 9 Jul 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- :Children who present pain and/or spontaneous sensitivity,
- motor difficulties and
- health disorders .
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Marilia G Gomes
Ribeirão Preto, São Paulo, 14021-370
Marília Gr Gomes, Master, 11993155133, m_goulardins@usp.br
Marília Goulardins, 55 11993155133, m_goulardins@usp.br
About this study
Official title: 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.
Read the 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.
- Conditions
- Dental Caries in Children
- Being tested
- Teleorientation and Tooth Brushing Orientation
- Keywords
- eHealth, mobile health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teleorientation and Tooth Brushing OrientationOther
Guide children in toothbrushing with a preventive purpose during the COVID-19 pandemic
| Study group | Role | What they receive |
|---|---|---|
| Group Whatsapp | Active comparator | Will receive standardized brushing Teleorientation consultation through the Whatsapp communication platform Receives: Other: Teleorientation and Tooth Brushing Orientation |
| Group Vídeo for Health | Active comparator | You will receive a standardized brushing Teleorientation consultation through the V4H Platform, created specifically for Teleconsultations Receives: Other: Teleorientation and Tooth Brushing Orientation |
| Group de Orientação presencial | Active comparator | You will receive a standardized face-to-face brushing orientation consultation. Receives: Other: Teleorientation and Tooth Brushing Orientation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Individual assessment of groups
Assess the children's visible plaque index individually by photo
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start1 Jun 2021
- Primary completion9 Jul 2021
- Study completion9 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental Caries in ChildrenStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marília Goulardins, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04967794
- Sponsor's protocol ID
- CAAE 39685920.7.0000.5419
- Status last verified
- Jul 2021
- First submitted
- 9 Jul 2021
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Make the study visible to other researchers through the sharing link
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.
PubMed 32827598
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Teleorientation in Oral Hygiene During the COVID-19 Pandemic, a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04967794
- Acronym / sponsor ID
- CAAE 39685920.7.0000.5419
- Conditions
- Dental Caries in Children
- Keywords
- eHealth, mobile health
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 9 Jul 2021 (actual)
- Study completion
- 9 Jul 2021 (estimated)
- First posted
- 20 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Group Whatsapp | Active comparator | Other: Teleorientation and Tooth Brushing OrientationWill receive standardized brushing Teleorientation consultation through the Whatsapp communication platform |
| Group Vídeo for Health | Active comparator | Other: Teleorientation and Tooth Brushing OrientationYou will receive a standardized brushing Teleorientation consultation through the V4H Platform, created specifically for Teleconsultations |
| Group de Orientação presencial | Active comparator | Other: Teleorientation and Tooth Brushing OrientationYou will receive a standardized face-to-face brushing orientation consultation. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- :Children who present pain and/or spontaneous sensitivity,
- motor difficulties and
- health disorders .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Teleorientation and Tooth Brushing OrientationGuide children in toothbrushing with a preventive purpose during the COVID-19 pandemic | Other | Group Vídeo for Health, Group Whatsapp, Group de Orientação presencial |
Primary outcome
Individual assessment of groups
Time frame: 1 month
Assess the children's visible plaque index individually by photo
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
- Background: PubMed 32827598Lotto 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.
- Individual participant dataSharing planned: No. Make the study visible to other researchers through the sharing link
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Teleorientation and Tooth Brushing Orientation in people with Dental Caries in Children, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marília Goulardins (11993155133, m_goulardins@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Individual assessment of groups (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04967794, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2021.