title: Selective or stepwise removal of deep caries in deciduous molars: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  For treating deep caries lesions, selective or stepwise (one- and two-step) incomplete excavation seems advantageous compared with complete caries removal. However, current evidence regarding the success, as defined by not requiring any retreatments, or survival of teeth after different excavations is insufficient for definitive recommendation, especially when treating deciduous teeth. Moreover, restoration integrity has not been comparatively analyzed longitudinally, and neither patients', dentists' or parents' preferences nor the clinical long-term costs emanating from both initial and retreatments have been reported yet.
  
  
  METHODS
  The planned study is a prospective multicenter, two-arm parallel group, randomized controlled clinical trial comparing selective and stepwise excavation in deciduous molars with deep, active caries lesions without pulpal symptoms. We will recruit 300 children aged between three and nine-years-old with a minimum of one such molar. Patients participating in another study, or those with systemic diseases, disabilities or known allergies to used materials as well patients with teeth expected to exfoliate within the next 18 months will be excluded. After inclusion, sequence generation will be performed. Initial treatment will follow dental routine. During excavation, leathery, moist and reasonably soft dentin will be left in proximity to the pulp followed by adhesive restoration of the cavity. Afterwards, patients', dentists' and parents' subjective assessment of the treatment will be recorded using visual analogue or Likert scales. Re-examination will be performed after six months, and only then teeth will be allocated to one of the two interventions. Selectively excavated teeth will not be treated further, whilst for stepwise caries removal, a second excavation will be performed until only hard dentin remains. Clinical re-evaluations will be performed after 12, 24 and 36 months. Restorations will be reassessed using modified Ryge criteria. Objectively or subjectively required retreatments will determine success and survival. Retreatments will be evaluated both subjectively and regarding generated costs.
  
  
  CONCLUSIONS
  Based on the results of the trial, decision-making for treating deep caries lesions in deciduous molars based on multiple criteria should be feasible.
  
  
  BACKGROUND
  Clinicaltrials.gov identifier: NCT02232828 (registered on 29 November 2014).
authors.affiliation: Department of Operative and Preventive Dentistry, Charité - Universitätsmedizin, Aßmannshauser Str 4-6, Berlin, 14197, Germany. falk.schwendicke@charite.de.
authors.forename: Falk
authors.initials: F
authors.lastname: Schwendicke
authors.affiliation: DMG Dental Material Gesellschaft, Department of Clinical Research, Elbgaustr 248, Hamburg, 22547, Germany. hschweigel@dgm-dental.com.
authors.forename: Hardy
authors.initials: H
authors.lastname: Schweigel
authors.affiliation: Department of Operative Dentistry, Periodontology and Preventive Dentistry, RWTH University of Aachen, Pauwelsstr 30, Aachen, 52074, Germany. mpetrou@ukaachen.de.
authors.forename: Marina Agathi
authors.initials: MA
authors.lastname: Petrou
authors.affiliation: Department of Preventive and Paediatric Dentistry, Ernst-Moritz-Arndt University of Greifswald, Rotgerberstr 8, Greifswald, 17487, Germany. ruth.santamaria@uni-greifswald.de.
authors.forename: Ruth
authors.initials: R
authors.lastname: Santamaria
authors.affiliation: Institute of Medical Biometrics and Clinical Epidemiology, Charité - Universitätsmedizin, Hindenburgdamm 30, Berlin, 12203, Germany. werner.hopfenmueller@charite.de.
authors.forename: Werner
authors.initials: W
authors.lastname: Hopfenmüller
authors.affiliation: Department of Orthodontics, Dentofacial Orthopedics and Pedodontics, Charité - Universitätsmedizin, Aßmannshauser Str 4-6, Berlin, 14197, Germany. christian.finke@charite.de.
authors.forename: Christian
authors.initials: C
authors.lastname: Finke
authors.affiliation: Department of Operative and Preventive Dentistry, Charité - Universitätsmedizin, Aßmannshauser Str 4-6, Berlin, 14197, Germany. sebastian.paris@charite.de.
authors.forename: Sebastian
authors.initials: S
authors.lastname: Paris
mesh_terms: D002985:Clinical Protocols; D003625:Data Collection; D003627:Data Interpretation, Statistical; D003731:Dental Caries / Q000628:therapy*; D006801:Humans; D008963:Molar; D011446:Prospective Studies; D014094:Tooth, Deciduous