title: "Everybody brush!": protocol for a parallel-group randomized controlled trial of a family-focused primary prevention program with distribution of oral hygiene products and education to increase frequency of toothbrushing.
abstract: BACKGROUND
  Twice daily toothbrushing with fluoridated toothpaste is the most widely advocated preventive strategy for dental caries (tooth decay) and is recommended by professional dental associations. Not all parents, children, or adolescents follow this recommendation. This protocol describes the methods for the implementation and evaluation of a quality improvement health promotion program.
  
  
  OBJECTIVE
  The objective of the study is to show a theory-informed, evidence-based program to improve twice daily toothbrushing and oral health-related quality of life that may reduce dental caries, dental treatment need, and costs.
  
  
  METHODS
  The design is a parallel-group, pragmatic randomized controlled trial. Families of Medicaid-insured children and adolescents within a large dental care organization in central Oregon will participate in the trial (n=21,743). Families will be assigned to one of three groups: a test intervention, an active control, or a passive control condition. The intervention aims to address barriers and support for twice-daily toothbrushing. Families in the test condition will receive toothpaste and toothbrushes by mail for all family members every three months. In addition, they will receive education and social support to encourage toothbrushing via postcards, recorded telephone messages, and an optional participant-initiated telephone helpline. Families in the active control condition will receive the kit of supplies by mail, but no additional instructional information or telephone support. Families assigned to the passive control will be on a waiting list. The primary outcomes are restorative dental care received and, only for children younger than 36 months old at baseline, the frequency of twice-daily toothbrushing. Data will be collected through dental claims records and, for children younger than 36 months old at baseline, parent interviews and clinical exams.
  
  
  RESULTS
  Enrollment of participants and baseline interviews have been completed. Final results are expected in early summer, 2017.
  
  
  CONCLUSIONS
  If proven effective, this simple intervention can be sustained by the dental care organization and replicated by other organizations and government.
  
  
  BACKGROUND
  
  
  
  BACKGROUND
  ClinicalTrials.gov NCT02327507; http://clinicaltrials.gov/ct2/show/NCT02327507 (Archived by WebCite at http://www.webcitation.org/6YCIxJSor).
authors.affiliation: Northwest Center to Reduce Oral Health Disparities, Department of Oral Health Sciences, University of Washington, Seattle, WA, United States.
authors.forename: Joana
authors.identifier: http://orcid.org/0000-0002-8276-9838
authors.initials: J
authors.lastname: Cunha-Cruz
authors.forename: Peter
authors.identifier: http://orcid.org/0000-0003-0784-9181
authors.initials: P
authors.lastname: Milgrom
authors.forename: R Michael
authors.identifier: http://orcid.org/0000-0003-0975-1559
authors.initials: RM
authors.lastname: Shirtcliff
authors.forename: Colleen E
authors.identifier: http://orcid.org/0000-0003-2140-8243
authors.initials: CE
authors.lastname: Huebner
authors.forename: Sharity
authors.identifier: http://orcid.org/0000-0003-3034-6419
authors.initials: S
authors.lastname: Ludwig
authors.forename: Gary
authors.identifier: http://orcid.org/0000-0002-7559-4283
authors.initials: G
authors.lastname: Allen
authors.forename: JoAnna
authors.identifier: http://orcid.org/0000-0002-5769-0212
authors.initials: J
authors.lastname: Scott
keywords: communication; dental care; dental devices, home care; oral hygiene; social support; toothbrushing