Trials / Not Yet Recruiting
Not Yet RecruitingNCT07383259
Comparison of Maxillary Protraction Using Tooth-borne Facemask Versus Skeletal Anchorage Chin-plate in Class III Growing Patients
Skeletal and Dentoalveolar Effects of Tooth-borne Facemask Versus Skeletal Anchorage Chin-plate Maxillary Protraction in Growing Class III Patients.
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- Sponsor
- Universidad Complutense de Madrid · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2026-02-01
- Primary completion
- 2026-12-01
- Completion
- 2027-03-01
- First posted
- 2026-02-03
- Last updated
- 2026-02-03
Source: ClinicalTrials.gov record NCT07383259. Inclusion in this directory is not an endorsement.