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Not yet recruiting NCT07383259

Comparison of Maxillary Protraction Using Tooth-borne Facemask Versus Skeletal Anchorage Chin-plate in Class III Growing Patients

No phase Interventional Skeletal Class III Malocclusion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tooth-Borne Expander with Facemask (FM), Hybrid Skeletal Anchorage Expander with Chin-Plate (SA).
Who it may be relevant to
Registry conditions: Skeletal Class III Malocclusion. Basic parameters: up to 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Skeletal and Dentoalveolar Effects of Tooth-borne Facemask Versus Skeletal Anchorage Chin-plate Maxillary Protraction in Growing Class III Patients.

Overview

This retrospective non-randomized controlled clinical trial aimed to compare the skeletal and dentoalveolar effects of two orthopedic treatment protocols for skeletal Class III malocclusion in growing patients: a conventional tooth-borne rapid maxillary expansion combined with facemask therapy, and a hybrid skeletal anchorage expander combined with chin-plate traction. Lateral cephalometric changes before and after maxillary protraction were analyzed to assess sagittal skeletal correction and dentoalveolar effects.

Detailed description

Skeletal Class III malocclusion is frequently associated with maxillary growth deficiency and presents significant functional and esthetic challenges. Conventional treatment using rapid maxillary expansion combined with facemask therapy is effective but limited by patient compliance and undesirable dentoalveolar effects. The introduction of skeletal anchorage devices allows the application of orthopedic forces with reduced dental compensation and extended effectiveness beyond early growth stages.

This study retrospectively evaluated growing patients (CVS1-CVS3) treated with either a tooth-borne expander and facemask or a hybrid skeletal anchorage expander combined with chin-plate traction. Cephalometric variables were measured before treatment (T0) and after completion of maxillary protraction (T1) to compare skeletal and dentoalveolar changes between protocols.

Interventions

  • Device Tooth-Borne Expander with Facemask (FM)
    Bonded acrylic splint-type Hyrax expander with hooks in the maxillary canine region. Expansion activated once daily (0.25 mm). Facemask therapy initiated two weeks after expansion onset with 400 g per side of elastic traction, directed approximately 30° downward relative to the occlusal plane, worn 14-16 hours per day.
  • Device Hybrid Skeletal Anchorage Expander with Chin-Plate (SA)
    Modified Hybrid Hyrax expander supported by first molars and anchored with miniscrews placed bilaterally in a paramedian position. Expansion activated once daily (0.25 mm). Mandibular chin-plates (bollard-type or single chin-plate depending on eruption stage) were surgically inserted, and Class III elastics delivering 400 g per side were applied following a progressive loading protocol.

Primary outcome measures

  • Change in sagittal skeletal relationship [Time frame: From baseline (T0) through study completion, an average of 1 year (T1)]
Secondary outcome measures (3)
  • Cephalometric vertical skeletal changes [Time frame: From baseline (T0) through study completion, an average of 1 year (T1)]
  • Cephalometric dentoalveolar changes [Time frame: From baseline (T0) through study completion, an average of 1 year (T1)]
  • Treatment duration [Time frame: From baseline (T0) through study completion, an average of 1 year (T1)]

Eligibility criteria

Inclusion criteria

  • Growing patients (CVS1-CVS3)
  • Patent midpalatal suture (stages A-C)
  • Skeletal Class III malocclusion (ANB < 0°, Wits < -2 mm)
  • Presence of anterior crossbite or edge-to-edge incisal relationship Exclusion Criteria
  • Severe craniofacial asymmetry
  • Evidence of active condylar growth
  • Previous orthodontic treatment
  • Craniofacial malformations or syndromes
  • Systemic diseases or medications affecting growth or bone metabolism

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07383259 · Mentoplac_FaceMask

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗