The effectiveness of bone anchored maxillary protraction (BAMP) in the management of class III skeletal malocclusion in children aged 11-14 years compared with an untreated control group: A multicentre two-arm parallel randomised controlled trial.

OBJECTIVE: To evaluate the effectiveness of bone anchored maxillary protraction (BAMP) in the management of class III skeletal malocclusion in children aged 11-14 years compared with an untreated control group in terms of perceived need for orthognathic surgery, skeletal and dental change, and psychological impact. DESIGN: A multicentre two-armed parallel randomised controlled trial. SETTING: Six UK hospital orthodontic units. METHODS: A total of 57 patients were randomly allocated into either the BAMP group (BAMPG) (n = 28) or a no treatment control group (CG) (n = 29). OUTCOMES: Data collection occurred at registration (DC1),18 months (DC2) and 3 years (DC3), where skeletal and dental changes were measured from lateral cephalograms and study models. Oral Aesthetic Subjective Impact Score (OASIS) and Oral Quality of Life (OHQOL) questionnaires were used to assess the psychological impact of treatment. RESULTS: The mean age was 12.9 ± 0.7 years and 12.6 ± 0.9 years in the BAMPG and CG, respectively. At DC2, the BAMPG achieved a class III ANB improvement of +0.6° compared with -0.7° in the CG (P = 0.004). The overjet improvement was +1.4 mm for the BAMPG and -0.2 mm for the CG (P = 0.002). There was no evidence of any other group differences for the other skeletal or dental cephalometric outcomes (P > 0.05) or the questionnaire data (OASIS P = 0.10, OHQOL P = 0.75). At DC2, the 18-month follow-up, 22% of the BAMPG achieved a positive overjet. At the 3-year follow-up (DC3), fewer patients in the BAMPG were perceived to need orthognathic surgery (48%) compared with 75% of patients in the CG (P = 0.04), with an odds ratio of 0.31 (95% confidence interval = 0.10-0.95). CONCLUSION: The BAMP technique did not show any social or psychological benefits; however, the skeletal class III improvement in ANB and the overjet change were sufficient to reduce the perceived need for orthognathic surgery by 27% compared with the CG.

Early class III protraction facemask treatment reduces the need for orthognathic surgery: a multi-centre, two-arm parallel randomized, controlled trial.

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. DESIGN: Multi-centre 2-arm parallel randomized controlled trial. SETTING: Eight United Kingdom hospital orthodontic departments. PARTICIPANTS: Seventy three 7- to 9-year-old children. METHOD: 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.

Is early Class III protraction facemask treatment effective? A multicentre, randomized, controlled trial: 3-year follow-up.

OBJECTIVE: To investigate the effectiveness of early class III protraction facemask treatment in children under 10 years of age at 3-year follow-up. DESIGN: Multicentre randomized controlled trial. SUBJECTS AND METHODS: Seventy-three patients were randomly allocated, stratified for gender, into early class III protraction facemask group (PFG) (n = 35) and a control/no treatment group (CG) (n = 38). OUTCOMES: Dentofacial changes were assessed 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 oral aesthetic subjective impact score (OASIS) questionnaire. Temporomandibular joint (TMJ) signs and symptoms were also recorded. The time points for data collection were at registration (DC1), 15 months later (DC2) and 3 years post-registration (DC3). RESULTS: The following mean skeletal and occlusal changes occurred from the class III starting point to DC3 (3-year follow-up): SNA, PFG moved forwards +2·3° (CG forward +1·6°; P = 0·14); SNB, PFG moved forwards +0·8° (CG forward +1·5°, P = 0·26); ANB, PFG class III base improved +1·5° (CG stayed about the same at +0·1°; P = 0·001). This contributed to an overall difference in ANB between PFG and CG of +1·4° in favour of early protraction facemask treatment. The overjet was still improved by +3·6 mm in the PFG and changed a small amount +1·1 mm in the CG (P = 0·001). A 21% improvement in PAR was shown in the PFG and the CG worsened by 8·4% (P = 0·02). There was no increase in self-esteem (Piers-Harris score) for PFG compared with the CG (P = 0·56) and no statistically significant difference in the impact of malocclusion (OASIS) between groups in terms of the changes from DC1 to DC3 (P = 0·18). TMJ signs and symptoms were very low at DC1 and DC3. CONCLUSIONS: The favourable effect of early class III protraction facemask treatment undertaken in patients under 10 years of age, is maintained at 3-year follow-up in terms of ANB, overjet and % PAR improvement. The direct protraction treatment effect at SNA is still favourable although not statistically significantly better than the CG. Seventy per cent of patients in PFG had maintained a positive overjet which we have defined as ongoing treatment success. Early protraction facemask treatment does not seem to influence self-esteem or reduce the patient's personal impact of their malocclusion at 3-year follow-up.

Is early Class III protraction facemask treatment effective? A multicentre, randomized, controlled trial: 15-month follow-up.

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) (n = 35) and a control/no treatment group (CG) (n = 38). 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 1.4 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.