Background With the COVID-19 pandemic, thousands of children had their dental care interrupted or postponed, generating a pent-up demand for primary care. To minimize the impact of this outage, information and communication technologies (ICT) could be an alternative. The aim of this study is to elucidate the impact of implementing the ICTs in primary dental care for children on resolving the pent-up demand for primary dental care to children in the national health system service (SUS) due to the COVID-19 pandemic. Methods Different research strategies are being proposed to demonstrate such effect and extrapolating findings to a real-world context to guide further research, practice and policies: two clinical trials (one randomized controlled by the waiting list trial (RCT) and a before-and-after study), one simulation study to prospect trial results to a broader population and three economic evaluations using different effects. Children enrolled in a reference dental unit will be invited to participate in the before-and-after study for trials. The first 368 families will be randomized for the RCT to the intervention vs waiting list. All participants will receive the intervention, but the waiting list group will be assessed before the intervention is available for them. The intervention comprises standardized non-face-to-face primary dental care using the V4H platform. The problem-solving and the family's perception will be the primary outcomes set for the before-and-after study and RCT, respectively. They will be measured 2 weeks after randomization. Based on trial findings, we will develop theoretical models to estimate how the intervention could benefit the population included in the national health system. Three economic evaluations will be carried out considering different trial effects (cost-effectiveness analyses). A societal perspective and the pandemic time horizon will be considered. Possible social impact (inequalities) will also be explored. Discussion This ongoing trial may be an essential contribution to clarify positive and negative aspects related to the use of technologies for non-face-to-face dental care for children. Trial products may bring relevant contributions to the pandemic context and the post-pandemic period. Potential benefits may be feasible to implement and preserve in the health system even in the post-pandemic period. Trial registration Clinicaltrials.gov registration NCT04798599 (registered March 2021).
Background Studies have questioned the necessity of restoring cavitated carious lesion on primary teeth, once the control of biofilm is the most important factor to arrest these lesions. This randomized clinical trial aimed to compare the survival of teeth treated with a non-restorative cavity control (NRCC) compared to resin composite restorations (RCR) on proximal carious lesion in anterior primary teeth, as well as the impact of these treatments on patient-centered outcomes. Methods A randomized clinical trial with two parallels arms (1:1) will be conducted. Children between 3 and 6 years old will be selected from the Center of Clinic Research of Pediatric Dentistry of Ibirapuera University (UNIB), a dental trailer (FOUSP) located on Educational Complex Professor Carlos Osmarinho de Lima, the Pediatric Dentistry Clinic of Santa Cecília University and from the Pediatric Dentistry Clinic of University Center UNINOVAFAPI. One hundred and forty-eight teeth will be randomly distributed in two experimental groups: (1) Selective removal of carious tissue and RCR; or (2) NRCC through cavity enlargement using a metallic sandpaper. The primary outcome will be tooth survival after 6, 12, 18 and 24 months. The duration and the cost of dental treatments will be considered for the estimation of the cost-effectiveness of the evaluated treatments. The discomfort reported by the participants will be measured after each treatment using the FIS scale. The participants’ satisfaction and perception of the parents/legal guardians will be evaluated through questionnaires. For the primary outcome, Kaplan–Meier’s survival and Long-Rank test will be used for comparison between the two groups. All the variables will be modeled by Cox regression with shared fragility. Significance will be considered at 5%. Discussion The NRCC could be an option to manage carious lesions on proximal surfaces of primary teeth, and the approach could be well accepted by the children and parents/legal guardians. Trial registration Clinicaltrials.gov registration: NCT03785730, Registered on December 18th 2018, first participant recruited 30/04/2019, https://clinicaltrials.gov/ct2/show/NCT03785730. Ethics Reference No: 91569118.8.0000.5597. Trial Sponsor: Universidade Ibirapuera. The Trial was prospectively registered.
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