title: Child oral health-related quality of life and early childhood caries: a non-inferiority randomized control trial.
abstract: The aim of this study was to compare changes in child oral health-related quality of life (COHRQoL) after treatment for early childhood caries (ECC) using two alternative treatment approaches.
  
  
  
  A randomized control trial with random allocation of parent/child dyads with ECC to test (minimum intervention) or control (standard care). Participating parents completed the Early Childhood Oral Health Impact Scale (ECOHIS) at baseline and follow-up. Changes in ECOHIS scores and extent of COHRQoL impacts between and within groups were tested using the chi-squared statistic for groups, Wilcoxon's rank-sum test, and matched-pairs signed-rank test.
  
  
  
  Two hundred and fifty-four children were randomized (test = 127; control = 127). At baseline, mean ECOHIS score 11.1, sd 8.2; mean age = 3.8 years, sd 0.90; mean dmft = 4.9, sd 4.0; and 59% male. After a mean interval of 11.4 months, 210 children were followed-up and returned a completed questionnaire (test = 111; control = 99). There was no significant difference in COHRQoL changes between test and control. For all the children combined, there were significantly fewer impacts at follow-up in the child and family domains and the total ECOHIS, Wilcoxon signed-rank test, p < 0.05.
  
  
  
  COHRQoL improved with primary dental care for ECC, and there was no statistically significant difference between test and control in the extent of the improvement.
authors.affiliation: Western Australian Department of Health and Dental Health Service, Western Australia, Australia.|Australian Research Centre for Population Oral Health, The University of Adelaide, South Australia, Australia.
authors.forename: P
authors.initials: P
authors.lastname: Arrow
authors.affiliation: Western Australian Department of Health and Dental Health Service, Western Australia, Australia.
authors.forename: E
authors.initials: E
authors.lastname: Klobas
mesh_terms: D001315:Australia; D002648:Child; D002675:Child, Preschool; D003731:Dental Caries / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D009909:Oral Health / Q000706:statistics & numerical data*; D010290:Parents; D011788:Quality of Life; D011795:Surveys and Questionnaires
keywords: Atraumatic treatment; early childhood caries; general anaesthesia; oral health-related quality of life; primary dental care