title: Is early Class III protraction facemask treatment effective? A multicentre, randomized, controlled trial: 15-month follow-up.
abstract: OBJECTIVE
  To investigate the effectiveness of early class III protraction facemask treatment in children under 10 years of age.
  
  
  METHODS
  Multicentre, randomized controlled trial.
  
  
  METHODS
  Eight UK hospital orthodontic units.
  
  
  METHODS
  Seventy-three patients were randomly allocated, stratified for gender, into an early class III protraction facemask group (PFG) (n = 35) and a control/no treatment group (CG) (n = 38).
  
  
  RESULTS
  Dentofacial changes from lateral cephalograms and occlusal changes using the peer assessment rating (PAR). Self-esteem was assessed using the Piers-Harris children's self-concept scale, and the psychosocial impact of malocclusion with an oral aesthetic subjective impact scores (OASIS) questionnaire. Temporomandibular joint (TMJ) signs and symptoms were also recorded. The time points for data collection were at registration (DC1) and 15 months later (DC2).
  
  
  RESULTS
  The following mean skeletal and occlusal changes occurred from the class III starting point: SNA, PFG moved forwards 1.4 degrees (CG forward 0.3 degrees; P = 0.018); SNB, PFG moved backwards -0.7 degrees (CG forward 0.8 degrees; P<0.001); ANB, PFG class III base improved +2.1 degrees (CG worsened by -0.5 degrees; P<0.001). This contributed to an overall difference in ANB between PFG and CG of 2.6 degrees in favour of early protraction facemask treatment. The overjet improved +4.4 mm in the PFG and marginally changed +0.3 mm in the CG (P<0.001). A 32.2% improvement in PAR was shown in the PFG and the CG worsened by 8.6%. There was no increased self-esteem (Piers-Harris score) for treated children compared with controls (P = 0.22). However, there was a reduced impact of malocclusion (OASIS score) for the PFG compared with the CG (P = 0.003), suggesting treatment resulted in slightly less concern about the tooth appearance. TMJ signs and symptoms were very low at DC1 and DC2 and none were reported during active facemask treatment.
  
  
  CONCLUSIONS
  Early class III orthopaedic treatment, with protraction facemask, in patients under 10 years of age, is skeletally and dentally effective in the short term and does not result in TMJ dysfunction. Seventy per cent of patients had successful treatment, defined as achieving a positive overjet. However, early treatment does not seem to confer a clinically significant psychosocial benefit.
authors.affiliation: Dr Nicky Anne Mandall, Tameside General Hospital, Ashton-u-Lyne, Lancashire, UK. Nicky.Mandall@tgh.nhs.uk
authors.forename: Nicky
authors.initials: N
authors.lastname: Mandall
authors.forename: Andrew
authors.initials: A
authors.lastname: DiBiase
authors.forename: Simon
authors.initials: S
authors.lastname: Littlewood
authors.forename: Spencer
authors.initials: S
authors.lastname: Nute
authors.forename: Nadia
authors.initials: N
authors.lastname: Stivaros
authors.forename: Ross
authors.initials: R
authors.lastname: McDowall
authors.forename: Inderjit
authors.initials: I
authors.lastname: Shargill
authors.forename: Helen
authors.initials: H
authors.lastname: Worthington
authors.forename: Richard
authors.initials: R
authors.lastname: Cousley
authors.forename: Fiona
authors.initials: F
authors.lastname: Dyer
authors.forename: Rye
authors.initials: R
authors.lastname: Mattick
authors.forename: Barbara
authors.initials: B
authors.lastname: Doherty
mesh_terms: D002508:Cephalometry; D016009:Chi-Square Distribution; D002648:Child; D004955:Esthetics, Dental; D005115:Extraoral Traction Appliances; D005260:Female; D006801:Humans; D016014:Linear Models; D008297:Male; D008313:Malocclusion, Angle Class III / Q000628:therapy*; D009971:Orthodontics, Corrective / Q000295:instrumentation*; D010155:Palatal Expansion Technique; D018024:Peer Review, Health Care; D011446:Prospective Studies; D012649:Self Concept; D016037:Single-Blind Method; D012928:Social Desirability; D016896:Treatment Outcome