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Clinical Trials/NCT07383259
NCT07383259Not yet recruitingNot Applicable

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

Universidad Complutense de Madrid0 sites36 target enrollmentStarted: February 1, 2026Last updated:
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
36
Primary Endpoint
Change in sagittal skeletal relationship

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
— to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Tooth-Borne Expander with Facemask (FM)

Active Comparator

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.

Intervention: Tooth-Borne Expander with Facemask (FM) (Device)

Hybrid Skeletal Anchorage Expander with Chin-Plate (SA)

Experimental

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.

Intervention: Hybrid Skeletal Anchorage Expander with Chin-Plate (SA) (Device)

Outcomes

Primary Outcomes

Change in sagittal skeletal relationship

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

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

Secondary Outcomes

  • Cephalometric vertical skeletal changes(From baseline (T0) through study completion, an average of 1 year (T1))
  • Cephalometric dentoalveolar changes(From baseline (T0) through study completion, an average of 1 year (T1))
  • Treatment duration(From baseline (T0) through study completion, an average of 1 year (T1))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Concepción Martín Alvaro

Full Professor

Universidad Complutense de Madrid

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