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Information and Communication Technologies (ICTS) in Dentistry for SUS

Primary Purpose

Dental Caries in Children, Dental Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Telemonitoring and teleorientation
Control Group - Waiting list
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dental Caries in Children focused on measuring Child, COVID-19, Information Technology

Eligibility Criteria

3 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of São PauloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Waiting list

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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)."

Secondary Outcome Measures

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.
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.
Demand resolution after intervention
Interview for checking about the resolution of demands pointed out during the baseline consultation.
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.
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.

Full Information

First Posted
March 8, 2021
Last Updated
March 12, 2021
Sponsor
University of Sao Paulo
Collaborators
Federal University of Paraíba, Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT04798599
Brief Title
Information and Communication Technologies (ICTS) in Dentistry for SUS
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Federal University of Paraíba, Federal University of São Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries in Children, Dental Diseases
Keywords
Child, COVID-19, Information Technology

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderOutcomes Assessor
Masking Description
One researcher, who will not participate in teleconsultations (intervention), will be responsible for the questionnaires before the intervention and will randomize the patients. This same researcher will distribute the patients randomly among the dentists responsible for teleconsultations. Dentists will also be blind as to the allocation of the patient to the groups. Also, to the patients/families, it will be not mentioned which group participants are part of. An external operator will be responsible for collecting information about the outcome (questionnaire after the interventions) will also not know which group the patient was allocated. As only the researcher responsible for randomization will know which group the patient belongs to and coordinate all operational parts of the teleconsultations, investigators can ensure the other operators and participants' blinding.
Allocation
Randomized
Enrollment
368 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Waiting list
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Telemonitoring and teleorientation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control Group - Waiting list
Intervention Description
No intervention (at least, until the time frame for outcome assessment)
Primary Outcome Measure Information:
Title
Family/patient´s perception about the dental care
Description
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)."
Time Frame
2 weeks after intervention (or one week of waiting - in the case of the control group)
Secondary Outcome Measure Information:
Title
Increment in caries experience since the interruption of dental care
Description
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.
Time Frame
1 year after intervention
Title
Increment or changes in the needs for dental treatment
Description
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.
Time Frame
1 year after intervention
Title
Demand resolution after intervention
Description
Interview for checking about the resolution of demands pointed out during the baseline consultation.
Time Frame
2 weeks after intervention
Title
Need for reorientation about oral hygiene
Description
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.
Time Frame
2 weeks, 3 months, 6 months, 1 year after intervention
Title
Perception of caregivers regarding primary care and dental care.
Description
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.
Time Frame
2 weeks after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mariana M Braga, PhD
Phone
55 11 30917835
Email
mmbraga@usp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Karina Haibara
Phone
55 11 30917835
Email
karina.natal@usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariana M Braga, PhD
Organizational Affiliation
USP
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of São Paulo
City
São Paulo
ZIP/Postal Code
05508000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariana Minatel Braga, Phd
Phone
992014818
Email
mmbraga@usp.br
First Name & Middle Initial & Last Name & Degree
Maria Eduarda Franco Viganó, Graduation
Phone
(11)99518-1964
Email
maria.vigano@usp.br

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35392886
Citation
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.
Results Reference
derived

Learn more about this trial

Information and Communication Technologies (ICTS) in Dentistry for SUS

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