Dental Caries in ChildrenNCT04798599
Information and Communication Technologies (ICTS) in Dentistry for SUS
A study testing Telemonitoring and teleorientation in people with Dental Caries in Children and Dental Diseases, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
At the time of the COVID-19 pandemic, thousands of children had their dental care interrupted or postponed, generating a pent-up demand for primary care. In order to minimize the impact of this outage of face-to-face care, information and communication technologies could be an alternative and even likely to be… Read more about this study
- Who is it for?
- Ages 3 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Children, Dental Diseases
- What is being tested?
- Telemonitoring and teleorientation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 368 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Dec 2020to 30 Jun 2022
- Phase
- Interventional
- 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 3 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children from 3 to 13 years old who are involved in clinical studies and who already undergo follow-up from 6 to 60 months in the mobile dental unit.
Who cannot join
- Guardian´s participants) who do not accept to participate in the research and if participants accept.
- Children who do not assent with participation in the research (when already literate). - For children aged 3 to 6 years, included in the research, the waiver of the need to fill out the term of free and informed assent was requested, considering that these children are not literate and would not be able to write, to assent with the participation. t
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
University of São Paulo
São Paulo, 05508000
Mariana Minatel Braga, Phd, 992014818, mmbraga@usp.br
Maria Eduarda Franco Viganó, Graduation, (11)99518-1964, maria.vigano@usp.br
About this study
Official title: Using Information and Communication Technologies (ICTs) to Solve the Repressed Demand for Primary Dental Care in the SUS Due to the COVID-19 Pandemic
At the time of the COVID-19 pandemic, thousands of children had their dental care interrupted or postponed, generating a pent-up demand for primary care. In order to minimize the impact of this outage of face-to-face care, information and communication technologies could be an alternative and even likely to be envisioned within the Brazilian Unified Health System (SUS). In this sense, this study sought to show the impact of the use of information and communication technologies (ICT) in the resolution of the pent-up demand for primary dental care to children in the SUS, due to the COVID-19 pandemic, proposing the use of telemonitoring, teleorientation and telescreening to resolve and address demands arising from this outage in primary elective care. The impact of the use of these strategies will be measured in terms of problem-solving, reduction of waiting time to resolve complaints and caregivers' perception about received care. For this, two clinical studies were designed and a primarily trial-based economic evaluation was planned. Mathematical models will be used to transpose these results into the reality of the SUS, in view of the State Health Secretariat of São Paulo and different Brazilian scenarios. Finally, the investigators also aim to study the possibility of implementing these technologies mentioned in the daily life of the SUS, even after a pandemic, and to check the possibility of incorporating and costing them, as well as exploring possible social impact and relationship with possible inequities in health.
Read the detailed description
Project Objectives:
This proposal has as a general objective to show the impact of the use of information and communication technologies (ICT) on the resolution of the pent-up demand for primary dental care to children in the SUS, due to the COVID-19 pandemic.
To this do so, the following specific objectives are defined:
- To identify the pent-up demand for the outage of dental care and the benefits and difficulties, as well as the perception of users, in the implementation of new strategies of non-face-to-face care based on technology (teleservice), using a primary care cell unit for children and prospecting, through models, this situation for the scenario of the Unified Health System (SUS).
- Perform different forms of economic evaluation to measure whether the gains achieved with the implementation of teleservice (telescreening, teleorientation and telemonitoring) compensate for the additional costs possibly associated with it, or whether teleservice modalities are associated with long-term resource savings, taking into account the implementation sized for the Brazilian public health system.
- Explore how the introduction of these technologies could benefit the SUS in the trans and post-pandemic period, contribute to the correction of possible inequities in health care and other social aspects, as well as result in possible differences when different Brazilian scenarios are explored.
- Conditions
- Dental Caries in Children, Dental Diseases
- Being tested
- Telemonitoring and teleorientation, Control Group - Waiting list
- Keywords
- Child, COVID-19, Information Technology
- Medical subject headings
- Stomatognathic Diseases, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemonitoring and teleorientationOther
Teleservice will be performed through a digital platform (Video for Health" - V4H). The service will consist of: a) recognition of the condition identified in the pandemic period, including updates on medical history, current oral health condition, search for dental care in other units, need for referral, change of hygiene habits, b) realization of diet guidance, hygiene and other necessary habits, made from a situational recognition of such habits, c) targeting the needs presented, in which individualized counselling will be given seeking to meet the demand presented by that family nucleus. A dental form developed on the digital platform Google Forms will serve as a guide for the performance of the service and where the collected data will be formally recorded. The guidelines, although individualized for the needs of each child, will follow a pre-defined and standardized structure and based on the best evidence available in the subject.
Control Group - Waiting listOther
No intervention (at least, until the time frame for outcome assessment)
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | In the intervention group there will be the application of the intervention - use of telemonitoring and teleorientation applied to children in primary care in Dentistry. Receives: Other: Telemonitoring and teleorientation |
| Waiting list | Active comparator | In the control group, children waiting to be booked to the intervention (in implementation in the unit because of the pandemic) will be evaluated for the outcomes. Only after the evaluation, the control group's children will be invited to perform the teleconsultation (proposed intervention). Receives: Other: Control Group - Waiting list |
What is being measured
The primary outcome is the main question the study is designed to answer.
Family/patient´s perception about the dental care
Evaluation of the quality of dental care to be measured by the SERVQUAL questionnaire (a multi-dimensional research instrument) - total of 22 items and 5 dimensions, comprising 4 items to capture tangibles, 5 items to capture reliability, 4 items for responsiveness, 4 items for assurance and 5 items to capture empathy.
A total of 100 points is allocated among the five dimensions. The participants evaluate the degree to which they perceived the proposed service. To identify participants' perceptions, one item asked, "How do you feel about these service attributes that are already provided?", which was scored on a 5-point Likert-type scale of "very bad (1)" to "very good (5)."
Measured: 2 weeks after intervention (or one week of waiting - in the case of the control group)
Secondary outcomes (5)
Increment in caries experience since the interruption of dental care
Clinical examination focused using dmft and DMFT indices and comparison to those. An previously recorded in participant´s records, resulting in the difference between the indices between these moments (DMFT+dmft final - DMFT+dmft when treatment was interrupted). An examiner unaware of baseline conditions will assess these indices.
Measured: 1 year after intervention
Increment or changes in the needs for dental treatment
Clinical examination focused in detecting if there is need for dental treatment or not (including untreated caries, need for restoration repair, need of gingival or periodontal treatment, need for extractions for any reason). An examiner unware of baseline conditions will assess such needs.
Measured: 1 year after intervention
Demand resolution after intervention
Interview for checking about the resolution of demands pointed out during the baseline consultation.
Measured: 2 weeks after intervention
Need for reorientation about oral hygiene
Interview for checking doubts about oral hygiene and checklist of items to be accomplished during oral hygiene demonstrated by child. An external examiner will evaluate all listed items. In case of any one is not checked, the need of reorientation is considered.
Measured: 2 weeks, 3 months, 6 months, 1 year after intervention
Perception of caregivers regarding primary care and dental care.
Semi-structured interviews, applied with guided questions to try to assess participants' and parents' perception, as well as potential barriers and facilitators associated with dental care during the pandemic period with the caregivers of the children who followed the teleservice. For this, individual interviews will be recorded and transcribed.
Measured: 2 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start1 Dec 2020
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jun 2022 (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
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This protocol refers to a randomized, patient-controlled study on a waiting list, nested to a before-after type study to be conducted in a cell unit, simulating a basic dental health unit. Next, a modelling study was idealized, prospecting the situation found for the reality and integral demand of the Unified Health System. The "before-after" study was designed to measure the positive and negative effects resulting from telecare implementation in primary care for children. The randomised controlled study evaluates the impact of teleservice implementation from the patient´s and parents perception and allows comparison with a reference. For that, children potentially eligible for the study will initially be randomized to one group (intervention vs waiting list). On the waiting list, participants will receive the intervention (standardized telecare) and will be evaluated for outcomes of interest two weeks later.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 368 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Paraíba, Federal University of São Paulo
- Responsible party
- Principal investigator, Mariana Minatel Braga, University of Sao Paulo
- Investigators
- Mariana M Braga, PhD, Principal investigator, USP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04798599
- Sponsor's protocol ID
- TeleDent-COVID19
- Status last verified
- Mar 2021
- First submitted
- 8 Mar 2021
- Last updated
- 15 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Natal KH, Machado TG, Bracco F, Lemos LI, Vigano ME, Machado GM, Yampa-Vargas JD, Raggio DP, Mendes FM, Imparato JCP, Lucena EHG, Cavalcanti YW, Silva CI, Souza Filho GL, Macedo MCS, Carrer FCA, Braga MM. Using information and communication technologies (ICTs) to solve the repressed demand for primary dental care in the Brazilian Unified Health System due to the COVID-19 pandemic: a randomized controlled study protocol nested with a before-and-after study including economic analysis. BMC Oral Health. 2022 Apr 7;22(1):112. doi: 10.1186/s12903-022-02101-9.
PubMed 35392886
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Information and Communication Technologies (ICTs) to Solve the Repressed Demand for Primary Dental Care in the SUS Due to the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04798599
- Acronym / sponsor ID
- TeleDent-COVID19
- Conditions
- Dental Caries in Children, Dental Diseases
- Keywords
- Child, COVID-19, Information Technology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 368 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Federal University of Paraíba, Federal University of São Paulo
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 15 Mar 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.
At the time of the COVID-19 pandemic, thousands of children had their dental care interrupted or postponed, generating a pent-up demand for primary care. In order to minimize the impact of this outage of face-to-face care, information and communication technologies could be an alternative and even likely to be envisioned within the Brazilian Unified Health System (SUS). In this sense, this study sought to show the impact of the use of information and communication technologies (ICT) in the resolution of the pent-up demand for primary dental care to children in the SUS, due to the COVID-19 pandemic, proposing the use of telemonitoring, teleorientation and telescreening to resolve and address demands arising from this outage in primary elective care. The impact of the use of these strategies will be measured in terms of problem-solving, reduction of waiting time to resolve complaints and caregivers' perception about received care. For this, two clinical studies were designed and a primarily trial-based economic evaluation was planned. Mathematical models will be used to transpose these results into the reality of the SUS, in view of the State Health Secretariat of São Paulo and different Brazilian scenarios. Finally, the investigators also aim to study the possibility of implementing these technologies mentioned in the daily life of the SUS, even after a pandemic, and to check the possibility of incorporating and costing them, as well as exploring possible social impact and relationship with possible inequities in health.
Detailed description
Project Objectives:
This proposal has as a general objective to show the impact of the use of information and communication technologies (ICT) on the resolution of the pent-up demand for primary dental care to children in the SUS, due to the COVID-19 pandemic.
To this do so, the following specific objectives are defined:
- To identify the pent-up demand for the outage of dental care and the benefits and difficulties, as well as the perception of users, in the implementation of new strategies of non-face-to-face care based on technology (teleservice), using a primary care cell unit for children and prospecting, through models, this situation for the scenario of the Unified Health System (SUS).
- Perform different forms of economic evaluation to measure whether the gains achieved with the implementation of teleservice (telescreening, teleorientation and telemonitoring) compensate for the additional costs possibly associated with it, or whether teleservice modalities are associated with long-term resource savings, taking into account the implementation sized for the Brazilian public health system.
- Explore how the introduction of these technologies could benefit the SUS in the trans and post-pandemic period, contribute to the correction of possible inequities in health care and other social aspects, as well as result in possible differences when different Brazilian scenarios are explored.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- This protocol refers to a randomized, patient-controlled study on a waiting list, nested to a before-after type study to be conducted in a cell unit, simulating a basic dental health unit. Next, a modelling study was idealized, prospecting the situation found for the reality and integral demand of the Unified Health System. The "before-after" study was designed to measure the positive and negative effects resulting from telecare implementation in primary care for children. The randomised controlled study evaluates the impact of teleservice implementation from the patient´s and parents perception and allows comparison with a reference. For that, children potentially eligible for the study will initially be randomized to one group (intervention vs waiting list). On the waiting list, participants will receive the intervention (standardized telecare) and will be evaluated for outcomes of interest two weeks later.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Telemonitoring and teleorientationIn the intervention group there will be the application of the intervention - use of telemonitoring and teleorientation applied to children in primary care in Dentistry. |
| Waiting list | Active comparator | Other: Control Group - Waiting listIn the control group, children waiting to be booked to the intervention (in implementation in the unit because of the pandemic) will be evaluated for the outcomes. Only after the evaluation, the control group's children will be invited to perform the teleconsultation (proposed intervention). |
Who may qualify
- Ages
- 3 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children from 3 to 13 years old who are involved in clinical studies and who already undergo follow-up from 6 to 60 months in the mobile dental unit.
Key exclusion criteria (2 listed)
- Guardian´s participants) who do not accept to participate in the research and if participants accept.
- Children who do not assent with participation in the research (when already literate). - For children aged 3 to 6 years, included in the research, the waiver of the need to fill out the term of free and informed assent was requested, considering that these children are not literate and would not be able to write, to assent with the participation. t
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 |
|---|---|---|
| Telemonitoring and teleorientationTeleservice will be performed through a digital platform (Video for Health" - V4H). The service will consist of: a) recognition of the condition identified in the pandemic period, including updates on medical history, current oral health condition, search for dental care in other units, need for referral, change of hygiene habits, b) realization of diet guidance, hygiene and other necessary habits, made from a situational recognition of such habits, c) targeting the needs presented, in which individualized counselling will be given seeking to meet the demand presented by that family nucleus. A dental form developed on the digital platform Google Forms will serve as a guide for the performance of the service and where the collected data will be formally recorded. The guidelines, although individualized for the needs of each child, will follow a pre-defined and standardized structure and based on the best evidence available in the subject. | Other | Intervention |
| Control Group - Waiting listNo intervention (at least, until the time frame for outcome assessment) | Other | Waiting list |
Primary outcome
Family/patient´s perception about the dental care
Time frame: 2 weeks after intervention (or one week of waiting - in the case of the control group)
Evaluation of the quality of dental care to be measured by the SERVQUAL questionnaire (a multi-dimensional research instrument) - total of 22 items and 5 dimensions, comprising 4 items to capture tangibles, 5 items to capture reliability, 4 items for responsiveness, 4 items for assurance and 5 items to capture empathy. A total of 100 points is allocated among the five dimensions. The participants evaluate the degree to which they perceived the proposed service. To identify participants' perceptions, one item asked, "How do you feel about these service attributes that are already provided?", which was scored on a 5-point Likert-type scale of "very bad (1)" to "very good (5)."
5 secondary outcomes
Increment in caries experience since the interruption of dental care
Time frame: 1 year after intervention
Increment or changes in the needs for dental treatment
Time frame: 1 year after intervention
Demand resolution after intervention
Time frame: 2 weeks after intervention
Need for reorientation about oral hygiene
Time frame: 2 weeks, 3 months, 6 months, 1 year after intervention
Perception of caregivers regarding primary care and dental care.
Time frame: 2 weeks after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2021.
- Derived from this study: PubMed 35392886Natal KH, Machado TG, Bracco F, Lemos LI, Vigano ME, Machado GM, Yampa-Vargas JD, Raggio DP, Mendes FM, Imparato JCP, Lucena EHG, Cavalcanti YW, Silva CI, Souza Filho GL, Macedo MCS, Carrer FCA, Braga MM. Using information and communication technologies (ICTs) to solve the repressed demand for primary dental care in the Brazilian Unified Health System due to the COVID-19 pandemic: a randomized controlled study protocol nested with a before-and-after study including economic analysis. BMC Oral Health. 2022 Apr 7;22(1):112. doi: 10.1186/s12903-022-02101-9.
- Individual participant dataSharing planned: No
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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.
Mariana M Braga, PhD principal investigator
USP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemonitoring and teleorientation in people with Dental Caries in Children and Dental Diseases, 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 1 inclusion and 2 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 15 Mar 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.
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 Mariana M Braga, PhD (55 11 30917835, mmbraga@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Family/patient´s perception about the dental care (time frame: 2 weeks after intervention (or one week of waiting - in the case of the control group)). 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 NCT04798599, 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 15 Mar 2021.