title: Effectiveness of a clinical guideline to improve dental health among orthodontically treated patients: study protocol for a cluster randomized controlled trial.
abstract: BACKGROUND
  White spot lesions (WSLs) occur as a side effect in over 25 % of patients who undergo orthodontic treatment, causing aesthetic problems and a risk of deeper enamel and dentine lesions. Dutch orthodontists show substantial variation in their application of WSL preventive measures, which include little incorporation of evidence from the literature. We recently developed an evidence-based clinical practice guideline (CPG) on this topic, which was further converted into a computerized clinical decision support system (CDSS) to facilitate its incorporation into clinical practice. The present study aimed to assess the effectiveness of this CPG-based CDSS, with regard to actually preventing WSL development during orthodontic treatment with fixed appliances compared to usual preventive measures. Our study also aimed to evaluate the effects of implementing the CPG-based CDSS into routine clinical practice using a multifaceted strategy.
  
  
  METHODS
  We designed a hybrid effectiveness-implementation study assessing both clinical effectiveness of the CPG and its implementation into routine practice. A total of 840 patients nested in 14 orthodontic practices will be randomly assigned as clusters to the intervention or the control arm. Patients recruited by the orthodontist in the intervention group will be treated following the CPG, while the usual preventative measures will be followed in the control arm. The primary outcome measure is the proportion of patients with newly formed or enlarged WSLs after 6-9 months of treatment with fixed appliances, and at the end of treatment, using the CPG for WSL prevention compared with usual preventive measures. An additional aim is to obtain some preliminary outcomes regarding the implementation process.
  
  
  CONCLUSIONS
  This study investigates the effectiveness of a newly developed guideline to improve oral health during orthodontic treatment, while simultaneously illuminating potential difficulties in adopting a guideline in general orthodontic practice. The innovative features of this study include the risk-based CDSS that discriminates between patients' oral health statuses with regard to preventive measure utilization in general orthodontic practices. Most studies focusing on WSL prevention apply the preventive intervention to each patient in an experimental setting, resulting in overtreatment and a disconnect from the real-world conditions in which the intervention is to be applied. Additionally, one of the overreaching goals of this initiative is to create a gold standard for WSL prevention during orthodontic treatment, against which future studies can compare new promising preventive measures and the readiness of clinicians to change and adopt new treatments. By doing so, we want to help bridge the gap between science and orthodontic clinical practice and improve the quality of oral health care.
  
  
  BACKGROUND
  This trial is registered with the Dutch Trial Registry of the Dutch Cochrane Center under number NTR5012 , registration date 2 March 2015.
authors.affiliation: Department of Orthodontics and Craniofacial Biology, Radboud University Medical Center, PO Box 9101, 6500 HB, Nijmegen, The Netherlands. Barbara.Oosterkamp@radboudumc.nl.
authors.forename: Barbara C M
authors.initials: BC
authors.lastname: Oosterkamp
authors.affiliation: Department of Orthodontics and Craniofacial Biology, Radboud University Medical Center, PO Box 9101, 6500 HB, Nijmegen, The Netherlands.
authors.forename: Afzal
authors.initials: A
authors.lastname: Wafae
authors.affiliation: Department of Orthodontics and Craniofacial Biology, Radboud University Medical Center, PO Box 9101, 6500 HB, Nijmegen, The Netherlands.
authors.forename: Jan G J H
authors.initials: JG
authors.lastname: Schols
authors.affiliation: College of Oral Science, Quality and Safety of Oral Health Care, Radboud University Medical Center, Nijmegen, The Netherlands.
authors.forename: Wil J M
authors.initials: WJ
authors.lastname: van der Sanden
authors.affiliation: Scientific Institute for Quality of Health Care, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands.
authors.forename: Michel
authors.initials: M
authors.lastname: Wensing
mesh_terms: D000293:Adolescent; D002648:Child; D002985:Clinical Protocols; D020000:Decision Support Systems, Clinical; D003661:Decision Support Techniques; D003731:Dental Caries / Q000209:etiology / Q000517:prevention & control*; D005260:Female; D019983:Guideline Adherence / Q000592:standards; D006801:Humans; D008297:Male; D009426:Netherlands; D009909:Oral Health / Q000592:standards*; D016382:Orthodontic Appliance Design; D009967:Orthodontic Appliances / Q000009:adverse effects*; D009970:Orthodontics / Q000592:standards*; D017410:Practice Guidelines as Topic / Q000592:standards*; D019239:Practice Patterns, Dentists' / Q000592:standards*; D012107:Research Design; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
keywords: Guideline; Oral health; Orthodontic treatment; Study protocol