title: Atraumatic Restorative Treatment compared to the Hall Technique for occluso-proximal cavities in primary molars: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  In many parts of the world, school-age children have high dental treatment needs; however, there is often low, or no, dental care provision. Although Atraumatic Restorative Treatment (ART) was developed to address this, its survival rate in occluso-proximal lesions is low. An alternative, the Hall Technique (HT) has shown better relative outcomes for occluso-proximal lesions, but has not been directly compared to ART or tested in field settings. This trial will compare ART and the HT for the most clinically- and cost-effective strategy for managing occluso-proximal lesions in primary molars, in a school setting, using low-technology and child-friendly dental techniques.
  
  
  METHODS
  This two-arm, parallel group, patient-randomized controlled, superiority trial will have treatment provided in schools. Schoolchildren (n = 124, age 6-8) with at least one occluso-proximal carious primary molar lesion will have random allocation to treatment with ART or HT. Baseline measures and outcome data will be assessed through participant report, clinical examination and parent report/questionnaires. The primary outcome is survival rate, a composite measure of absence of Minor Failures (a defect in the restoration/crown, but not interfering with tooth health) and Major Failures (signs or symptoms of irreversible pulp damage, such as dental fistula/abscess, tooth fracture or failures that cannot be repaired). Secondary outcomes are: (1) child-reported discomfort, (2) childrens' and (3) parents' concerns around dental appearance and (4) acceptability of treatments, (5) occlusal-vertical dimensions (OVD) changes, (6) plaque index, (7) gingival health, (8) decayed, missing, filled teeth in permanent teeth (DMFT)/decayed, missing, filled teeth in primary teeth (dmft), (9) oral health-related-quality of life, reported by children and parents/caregivers, (10) the incremental cost-effectiveness, and (11) operator effect. A trained and calibrated examiner will evaluate the treated teeth after 1 week, then 1, 6, 12, 24 and 36 months post treatment. Kaplan-Meier and Cox regression tests will be used to investigate the primary outcome. The Mann-Whitney or t test, Friedman test, paired t test or Wilcoxon test and Ordinal Logistic Regression Analysis will be used to analyze the secondary outcomes.
  
  
  CONCLUSIONS
  The results of this trial will support decision-making by clinicians and policy-makers for managing occluso-proximal lesions in settings with constrained resources and limited dental access.
  
  
  BACKGROUND
  www.clinicaltrials.gov, NCT02569047 , registered 5 October 2015.
authors.affiliation: Department of Cariology, Endodontics and Pedodontology, Academic Centre for Dentistry Amsterdam (ACTA), Gustav Mahlerlaan 3004, 1081, LA, Amsterdam, The Netherlands. d.hesse@acta.nl.
authors.forename: Daniela
authors.initials: D
authors.lastname: Hesse
authors.affiliation: Orthodontics and Pediatric Dentistry Department, Dental School, University of São Paulo (USP), Av. Prof. Lineu Prestes, 2227, 05508-000, São Paulo, Brazil.
authors.forename: Mariana Pinheiro
authors.initials: MP
authors.lastname: de Araujo
authors.affiliation: Orthodontics and Pediatric Dentistry Department, Dental School, University of São Paulo (USP), Av. Prof. Lineu Prestes, 2227, 05508-000, São Paulo, Brazil.
authors.forename: Isabel Cristina
authors.initials: IC
authors.lastname: Olegário
authors.affiliation: School of Dentistry, University of Dundee, Nethergate, Dundee, DD1 4HN, Scotland, UK.
authors.forename: Nicola
authors.initials: N
authors.lastname: Innes
authors.affiliation: Orthodontics and Pediatric Dentistry Department, Dental School, University of São Paulo (USP), Av. Prof. Lineu Prestes, 2227, 05508-000, São Paulo, Brazil.
authors.forename: Daniela Prócida
authors.initials: DP
authors.lastname: Raggio
authors.affiliation: Department of Cariology, Endodontics and Pedodontology, Academic Centre for Dentistry Amsterdam (ACTA), Gustav Mahlerlaan 3004, 1081, LA, Amsterdam, The Netherlands.
authors.forename: Clarissa Calil
authors.initials: CC
authors.lastname: Bonifácio
mesh_terms: D002648:Child; D002985:Clinical Protocols; D003442:Crowns; D057087:Dental Atraumatic Restorative Treatment / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D019140:Dental Care for Children; D003731:Dental Caries / Q000175:diagnosis / Q000628:therapy*; D019232:Dental Restoration Failure; D003793:Dental Restoration, Permanent / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D005260:Female; D005899:Glass Ionomer Cements; D006297:Health Services Accessibility; D006801:Humans; D053208:Kaplan-Meier Estimate; D016015:Logistic Models; D008297:Male; D008963:Molar; D009426:Netherlands; D017060:Patient Satisfaction; D016016:Proportional Hazards Models; D012107:Research Design; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D005899:Glass Ionomer Cements
keywords: Atraumatic restorative treatment (ART); Caries treatment; Clinical studies/trials; Glass ionomer cements; Pediatric dentistry; Primary teeth; The Hall Technique