SCIENTIFIC SECTION Is early class III protraction facemask treatment effective? A multicentre, randomized, controlled trial: 15-month follow-up Nicky Mandall Tameside General Hospital, Ashton-u-Lyne, Lancashire, UK. Richard Cousley Peterborough District Hospital, UK Andrew DiBiase Kent and Canterbury Hospital, UK Fiona Dyer Sheffield Dental Hospital, UK Simon Littlewood St Luke’s Hospital, Bradford, UK Rye Mattick Newcastle Dental Hospital, UK Spencer Nute Southend Hospital, UK Barbara Doherty Tameside General Hospital, UK Nadia Stivaros, Ross McDowall, Inderjit Shargill and Helen Worthington School of Dentistry, University of Manchester, UK Objective: To investigate the effectiveness of early class III protraction facemask treatment in children under 10 years of age. Design: Multicentre, randomized controlled trial. Setting: Eight UK hospital orthodontic units. Subjects and methods: Seventy-three patients were randomly allocated, stratified for gender, into an early class III protraction facemask group (PFG) (n535) and a control/no treatment group (CG) (n538). Outcomes: 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 1.4u (CG forward 0.3u; P50.018); SNB, PFG moved backwards 20.7u (CG forward 0.8u; P,0.001); ANB, PFG class III base improved z2.1u (CG worsened by 20.5u; P,0.001). This contributed to an overall difference in ANB between PFG and CG of 2.6u in favour of early protraction facemask treatment. The overjet improved z4.4 mm in the PFG and marginally changed z0.3 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 (P50.22). However, there was a reduced impact of malocclusion (OASIS score) for the PFG compared with the CG (P50.003), 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. Key words: Class III skeletal pattern, early orthopaedic treatment, protraction facemask, randomized controlled trial Received 28th September 2009; accepted 14th March 2010 Journal of Orthodontics, Vol. 37, 2010, 149–161 Address for correspondence: Dr Nicky Anne Mandall, Tameside General Hospital, Ashton-u-Lyne, Lancashire, UK. Email: Nicky.Mandall@tgh.nhs.uk # 2010 British Orthodontic Society DOI 10.1179/14653121043056