RESUMO
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.
RESUMO
OBJECTIVE: To evaluate whether delaying treatment with a twin block appliance affects treatment outcomes, in terms of skeletal and dental change and psychological disadvantage. DESIGN: Multicentre, two-arm parallel randomised controlled trial. SETTING: Three UK hospital orthodontic units. METHODS: A total of 75 participants were randomly allocated into an Immediate Treatment Group (ITG) (n= 41) and an 18-month delayed Later Treatment Group (LTG) (n=34). OUTCOMES: Dentofacial changes were recorded from lateral cephalograms and study models, psychological impact was measured using a child perception questionnaire (CPQ11-14) and an Oral Aesthetic Subjective Impact Score (OASIS) at registration (DC1), 18 months (DC2) and 3 years (DC3). RESULTS: The ITG initial effect was a mean ANB reduction was 1.6° (P<0.001) (95% confidence interval [CI] = 0.89-2.29), and an overjet reduction of 5.06 mm (P<0.001) (95% CI = 3.96-6.16) (boys: aged 12 years 8 months; girls: aged 11 years 8 months). There were no statistically significant differences between the ITG and LTG for twin block treatment outcomes, but the ITG active treatment time was longer (P=0.004) (ITG: 13.1 months; LTG: 9.8 months). There was insufficient evidence to state that patients were psychologically disadvantaged by waiting 18 months for active twin block treatment (P>0.05). CONCLUSION: Participants achieved similar clinical and psychological outcomes irrespective of whether they started their twin block at the age of referral (ITG) or 18 months later (LTG). This suggests that boys aged 12 years 8 months and girls aged 11 years 8 months, on average, are not disadvantaged by waiting 18 months for active twin block treatment.