Evidence map›Paper›PMID 27485432›Full record

Trial reportBMC oral health2016

Effectiveness of conventional treatment using bulk-fill composite resin versus Atraumatic Restorative Treatments in primary and permanent dentition: a pragmatic randomized clinical trial.

Isabel Cristina Olegário, Daniela Hesse, Marcelo Bönecker, José Carlos Pettorossi Imparato, Mariana Minatel Braga, Fausto Medeiros Mendes, Daniela Prócida Raggio

Registry-linked trialAbstract readPragmatic Clinical TrialRandomized Controlled Trial
In one paragraph

Trial report in BMC oral health, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02568917 (Effectiveness of Atraumatic Restorative Treatment and Conventional Restorations in Primary and Permanent Dentition), which is not on this map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02568917 nasuspendednot on this mapstarted 2020, after this paper: background citation

Effectiveness of Atraumatic Restorative Treatment and Conventional Restorations in Primary and Permanent Dentition: A Practice-based Clinical Trial

TypeinterventionalSponsorUniversity of Sao PauloRan2020 to 2022Enrolled800ConditionsDental CariesArmsAtraumatic Restorative Treatment - Ketac Molar Easy Mix, Conventional Restoration - Composite Resin (Bulk Fill)
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Isabel Cristina OlegárioDepartment of Paediatric Dentistry, School of Dentistry, Faculdade de Odontologia da Universidade de São Paulo, Av. Lineu Prestes, 2227, São Paulo, SP, 05508-000, Brazil.
Daniela HesseDepartment of Paediatric Dentistry, School of Dentistry, Faculdade de Odontologia da Universidade de São Paulo, Av. Lineu Prestes, 2227, São Paulo, SP, 05508-000, Brazil.
Marcelo BöneckerDepartment of Paediatric Dentistry, School of Dentistry, Faculdade de Odontologia da Universidade de São Paulo, Av. Lineu Prestes, 2227, São Paulo, SP, 05508-000, Brazil.
José Carlos Pettorossi ImparatoDepartment of Paediatric Dentistry, School of Dentistry, Faculdade de Odontologia da Universidade de São Paulo, Av. Lineu Prestes, 2227, São Paulo, SP, 05508-000, Brazil.
Mariana Minatel BragaDepartment of Paediatric Dentistry, School of Dentistry, Faculdade de Odontologia da Universidade de São Paulo, Av. Lineu Prestes, 2227, São Paulo, SP, 05508-000, Brazil.
Fausto Medeiros MendesDepartment of Paediatric Dentistry, School of Dentistry, Faculdade de Odontologia da Universidade de São Paulo, Av. Lineu Prestes, 2227, São Paulo, SP, 05508-000, Brazil.
Daniela Prócida RaggioDepartment of Paediatric Dentistry, School of Dentistry, Faculdade de Odontologia da Universidade de São Paulo, Av. Lineu Prestes, 2227, São Paulo, SP, 05508-000, Brazil. danielar@usp.br.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundClinical studies are being conducted in less strict conditions in order to establish an adequate scientific basis for decision making. The aim of this pragmatic randomized clinical trial is to evaluate the effectiveness of single and multiple-surfaces restorations performed following the Atraumatic Restorative Treatment (ART) premises compared with Conventional Treatment (CT) using bulk fill composite restorations in primary and permanent teeth. METHODS/

designA total of 1,214 5-to-13 year-old children with at least one single or multiple-surface dentin caries lesion in primary or permanent molars will be selected in public schools of Barueri-SP, Brazil. The participants will be randomly assigned into 2 groups: CT (caries removal with bur and restoration performed with Scotchbond™ Universal Adhesive system associated with Filtek Bulk Fill - 3 M/ESPE) and ART (Caries removal with hand instruments and restoration with high viscosity glass ionomer cement Ketac Molar Easy Mix - 3 M/ESPE). Ten untrained dentists will perform the treatment in in dental offices located at public schools. The restorations will be evaluated after 6, 12 and 24 months by an independent trained and calibrated examiner. The restoration and tooth survival, the cost-effectiveness analysis between the two groups and the operators' preferences regarding the techniques will be also evaluated. Kaplan-Meier survival analysis and log-rank test will be applied for the restoration and tooth survival. All the average event rates in the two groups will be modelled and compared with a Cox proportional hazard shared frailty model since there is an operator-cluster effect. The significance level for all analyses will be 5 %. DISCUSSION: Our hypothesis is that despite similar expected effectiveness between ART using high viscosity GIC and conventional treatment using bulk fill composite resin when treating single or multiple-surface in posterior primary and permanent teeth, ART will present superior cost-effectiveness. The results of this trial will support decision-making by clinicians and policy makers.

trial registrationNCT02568917 . Registered on May 10th 2015.

Indexed as

Dental Atraumatic Restorative TreatmentDental Restoration, PermanentDentition, PermanentAdolescentBrazilChildChild, PreschoolComposite ResinsDental CariesFemaleGlass Ionomer CementsHumansMaleComposite ResinsGlass Ionomer CementsAtraumatic Restorative TreatmentComposite resinCost effectiveness analysisGlass ionomer cementRandomized clinical trial

Identifiers

PMID27485432
PMCPMC4970260

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.