title: Early class III protraction facemask treatment reduces the need for orthognathic surgery: a multi-centre, two-arm parallel randomized, controlled trial.
abstract: OBJECTIVE
  To evaluate whether patients who had received early class III protraction facemask treatment were less likely to need orthognathic surgery compared with untreated controls. This paper is a 6-year follow-up of a previous clinical trial.
  
  
  METHODS
  Multi-centre 2-arm parallel randomized controlled trial.
  
  
  METHODS
  Eight United Kingdom hospital orthodontic departments.
  
  
  METHODS
  Seventy three 7- to 9-year-old children.
  
  
  METHODS
  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). The primary outcome, need for orthognathic surgery was assessed by panel consensus. Secondary outcomes were changed in skeletal pattern, overjet, Peer Assessment Rating (PAR), self-esteem and the oral aesthetic impact of malocclusion. The data were compared between baseline (DC1) and 6-year follow-up (DC4). A per-protocol analysis was carried out with n = 32 in the CG and n = 33 in the PFG.
  
  
  RESULTS
  Thirty six percent of the PFG needed orthognathic surgery, compared with 66% of the CG (P = 0.027). The odds of needing surgery was 3.5 times more likely when protraction facemask treatment was not used (odds ratio = 3.34 95% CI 1.21-9.24). The PFG exhibited a clockwise rotation and the CG an anti-clockwise rotation in the maxilla (regression coefficient 8.24 (SE 0.75); 95% CI 6.73-9.75; P < 0.001) and the mandible (regression coefficient 6.72 (SE 0.73); 95% CI 5.27-8.18; P < 0.001). Sixty eight per cent of the PFG maintained a positive overjet at 6-year follow-up. There were no statistically significant differences between the PFG and CG for skeletal/occlusal improvement, self-esteem or oral aesthetic impact.
  
  
  CONCLUSIONS
  Early class III protraction facemask treatment reduces the need for orthognathic surgery. However, this effect cannot be explained by the maintenance of skeletal cephalometric change.
authors: a Tameside Hospital NHS Foundation Trust , Lancashire , UK.
authors: Nicky
authors: N
authors: Mandall
authors: b Peterborough City Hospital , Peterborough , Cambridgeshire , UK.
authors: Richard
authors: R
authors: Cousley
authors: c Kent and Canterbury Hospital , Canterbury , Kent , UK.
authors: Andrew
authors: A
authors: DiBiase
authors: d Sheffield Dental Hospital , Sheffield , UK.
authors: Fiona
authors: F
authors: Dyer
authors: e St Luke's Hospital , Bradford , UK.
authors: Simon
authors: S
authors: Littlewood
authors: f Newcastle Dental Hospital , Newcastle upon Tyne , UK.
authors: Rye
authors: R
authors: Mattick
authors: g Southend Hospital , Westcliff-on-Sea , Essex , UK.
authors: Spencer J
authors: SJ
authors: Nute
authors: a Tameside Hospital NHS Foundation Trust , Lancashire , UK.
authors: Barbara
authors: B
authors: Doherty
authors: h Oldham Orthodontic Practice , Oldham , UK.
authors: Nadia
authors: N
authors: Stivaros
authors: i Queen Alexandra Hospital , Portsmouth , UK.
authors: Ross
authors: R
authors: McDowall
authors: j School of Dentistry , University of Manchester , Manchester , UK.
authors: Inderjit
authors: I
authors: Shargill
authors: j School of Dentistry , University of Manchester , Manchester , UK.
authors: Helen V
authors: HV
authors: Worthington
mesh_terms: D002508:Cephalometry; D002648:Child; D005115:Extraoral Traction Appliances; D005260:Female; D006801:Humans; D008297:Male; D008313:Malocclusion, Angle Class III; D008437:Maxilla; D057909:Orthognathic Surgery; D010155:Palatal Expansion Technique; D016896:Treatment Outcome; D006113:United Kingdom
keywords: Class III; ISRCTN: 10014340; interceptive treatment; orthognathic surgery; protraction facemask