Article Text
Abstract
Introduction Despite the widespread acceptance of conventional treatment using composite resin in primary teeth, there is limited evidence that this approach is the best option in paediatric clinics. Atraumatic restorative treatment (ART) using high-viscosity glass ionomer cement has gradually become more popular because it performs well in clinical studies, is easy to handle and is patient friendly. Therefore, the aim of this randomised clinical trial study is to compare the restoration longevity of conventional treatment using composite resin with that of ART in posterior primary teeth. As secondary outcomes, cost-efficacy and patient self-reported discomfort will also be tested.
Methods and analysis Children aged 3–6 years presenting with at least one occlusal and/or occlusal-proximal cavity will be randomly assigned to one of two groups according to the dental treatment: ART (experimental group) or composite resin restoration (control group). The dental treatment will be performed at a dental care trailer located in an educational complex in Barueri/SP, Brazil. The unit of randomisation will be the child. A sample size of 240 teeth with occlusal cavities and 188 teeth with occlusal-proximal cavities has been calculated. The primary outcome will be restoration longevity, which will be clinically assessed after 6, 12, 18 and 24 months by two examiners. The duration of the dental treatment and the cost of all materials used will be considered when estimating the cost-efficacy of each treatment. Individual discomfort will be measured after each dental procedure using the Facial Scale of Wong-Baker.
Ethics and dissemination This clinical trial was approved by the local ethics committee from the Faculty of Dentistry of the University of São Paulo (registration no. 1.556.018). Participants will be included after their legal guardians have signed an informed consent form containing detailed information about the research.
Trial registration number www.clinicaltrials.gov, NCT02562456; Pre-results.
- health economics
- oral medicine
- paediatrics
This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
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Footnotes
Contributors DPR, MMB, FMM and IF contributed to the conception of this trial. DPR was responsible for its design. DPR is the trial coordinator, and NML is the principal investigator. DPR, NML and IO drafted the protocol. IF is in charge of the recruitment of participants. NML is responsible for the patients’ treatment. CSS and LY are responsible for timekeeping, recording materials and organising treatment. TKT is responsible for patient evaluations over time. All authors critically reviewed and approved the final manuscript as submitted.
Competing interests None declared.
Ethics approval Local Ethics Committee of the Faculty of Dentistry, University of São Paulo, São Paulo, Brazil.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Not applicable yet. Any data have been collected.