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 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%…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 38 participants or records.
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