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

ConditionSkeletal Class III Malocclusion
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorUniversidad Complutense de Madrid

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Severe craniofacial asymmetry

Evidence of active condylar growth

Previous orthodontic treatment

Craniofacial malformations or syndromes

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tooth-Borne Expander with Facemask (FM)

    Device

    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.

  • Hybrid Skeletal Anchorage Expander with Chin-Plate (SA)

    Device

    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.

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: Tooth-Borne Expander with Facemask (FM)Active comparator 1 intervention
Group B: Hybrid Skeletal Anchorage Expander with Chin-Plate (SA)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in sagittal skeletal relationship

Changes in the cephalometric angles SNA, ANB, and Wits appraisal measured on lateral cephalograms between T0 and T1

Time frame
From baseline (T0) through study completion, an average of 1 year (T1)

Secondary outcomes

1

Cephalometric vertical skeletal changes

o Cephalometric vertical measurements from T0 to T1, using a customized cephalometric analysis based on Steiner, Tweed, and McNamara references: Mandibular plane to SN (Sella-Nasion) angle, ANS (Anterior Nasal Spine)-PNS (Posterior Nasal Spine) to Mandibular plane angle, and ANS-PNS to SN angle

Time frame
From baseline (T0) through study completion, an average of 1 year (T1)
2

Cephalometric dentoalveolar changes

o Upper and lower incisor inclination changes from T0 to T1 using a customized cephalometric analysis based on Steiner, Tweed, and McNamara references: U\_SN (Upper incisor to Sella-Nasion)and IMPA (Lower Incisor Mandibular Plane Angle)

Time frame
From baseline (T0) through study completion, an average of 1 year (T1)
3

Treatment duration

o Time elapsed between T0 and T1

Time frame
From baseline (T0) through study completion, an average of 1 year (T1)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidad Complutense de Madrid

Lead sponsor

Ortoestetic (https://ortoestetic.com)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: