Trial reportProgress in orthodontics2025
Long-term three-dimensional skeletal effects of hybrid hyrax with facemask versus mentoplate in growing Class III patients: a randomized controlled trial.
Trial report in Progress in orthodontics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 3 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
3 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Comparison Between Skeletally-Anchored and Conventional Maxillary Protraction in Growing Class ΙΙΙ Patients: A Systematic Review and Meta-Analysis.Clinical and experimental dental research · 2026Pooled it
- Evaluating the Predictive Potential of Patient-Specific Biomechanical Models in Class III Protraction Therapy.Bioengineering (Basel, Switzerland) · 2025Article
- Correction to: Long-term three-dimensional skeletal effects of hybrid hyrax with facemask versus mentoplate in growing Class III patients: a randomized controlled trial.Progress in orthodontics · 2025Article
Corrections and comments
- Erratum issued
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundEarly intervention in Class III malocclusion aims to prevent the need for surgery in adulthood by enhancing upper jaw growth while limiting lower jaw development. Although traditional facemask treatment remain common, bone-anchored devices are increasingly used, claiming better skeletal control and patient compliance. However, strong evidence supporting these advantages is limited.
methodsSingle-center, parallel-group, randomized controlled trial with 1:1 allocation ratio.
participants28 growing Class III patients (mean age 9.7 ± 1.3 years) in mixed dentition with skeletal class III malocclusion.
interventionsPatients were randomly assigned to either hybrid hyrax with facemask (HH + FM, n = 14) or hybrid hyrax with mentoplate (HH + MP, n = 14). All received Alt-RAMEC protocol expansion. FM group used 360-400 g/side elastic traction 12-14 h daily; MP group used 185 g/side continuous traction.
objectiveTo compare 5-year three-dimensional (3D) skeletal effects between HH + FM and HH + MP protocols. OUTCOME: Primary outcome was 3D volumetric changes of upper and lower jaw at 1 year (T1) and 5 years (T2) post-treatment, measured using low-dose CT scans. RANDOMIZATION: 28 patients were allocated to either treatment-protocols using sequentially numbered opaque, sealed envelopes. The randomization sequence was generated with a 1:1 allocation ratio. BLINDING: Due to the nature of the trial, the operator and children could not be blinded to the treatment allocation. However, blinding was used when assessing the outcomes.
resultsFollow-up: one patient was lost at the one-year follow-up and an additional three patients were lost at the 5-year-follow-up. OUTCOMES: At T2 (5 years), maxillary advancement was identical between both groups (0.85 mm ± 0.5). Mandibular growth control showed minimal difference (FM: - 0.01 mm ± 0.24; MP: 0.10 mm ± 0.33). No significant differences were found between groups for any skeletal measurements (p > 0.05). Male patients showed lager mandibular changes both signed (p < 0.03) and unsigned (p < 0.01). HARMS: minor harms were encountered with the anchor hooks (fracture or mucosal irritation), however none led to treatment cessation.
conclusionsBoth protocols demonstrated comparable long-term skeletal effects in Class III correction. Treatment choice should be based on individual patient factors rather than assumed mechanical advantages.
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