- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04798599
Information and Communication Technologies (ICTS) in Dentistry for SUS
Using Information and Communication Technologies (ICTs) to Solve the Repressed Demand for Primary Dental Care in the SUS Due to the COVID-19 Pandemic
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mariana M Braga, PhD
- Phone Number: 55 11 30917835
- Email: mmbraga@usp.br
Study Contact Backup
- Name: Karina Haibara
- Phone Number: 55 11 30917835
- Email: karina.natal@usp.br
Study Locations
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São Paulo, Brazil, 05508000
- Recruiting
- University of Sao Paulo
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Contact:
- Mariana Minatel Braga, Phd
- Phone Number: 992014818
- Email: mmbraga@usp.br
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Contact:
- Maria Eduarda Franco Viganó, Graduation
- Phone Number: (11)99518-1964
- Email: maria.vigano@usp.br
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
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.
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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.
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Active Comparator: Waiting list
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).
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No intervention (at least, until the time frame for outcome assessment)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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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)." |
2 weeks after intervention (or one week of waiting - in the case of the control group)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Increment in caries experience since the interruption of dental care
Time Frame: 1 year after intervention
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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.
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1 year after intervention
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Increment or changes in the needs for dental treatment
Time Frame: 1 year after intervention
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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.
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1 year after intervention
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Demand resolution after intervention
Time Frame: 2 weeks after intervention
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Interview for checking about the resolution of demands pointed out during the baseline consultation.
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2 weeks after intervention
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Need for reorientation about oral hygiene
Time Frame: 2 weeks, 3 months, 6 months, 1 year after intervention
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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.
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2 weeks, 3 months, 6 months, 1 year after intervention
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Perception of caregivers regarding primary care and dental care.
Time Frame: 2 weeks after intervention
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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.
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2 weeks after intervention
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mariana M Braga, PhD, USP
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TeleDent-COVID19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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