Skeletal Class III MalocclusionNCT07383259
Comparison of Maxillary Protraction Using Tooth-borne Facemask Versus Skeletal Anchorage Chin-plate in Class III Growing Patients
A study testing Tooth-Borne Expander with Facemask (FM) and Hybrid Skeletal Anchorage Expander with Chin-Plate (SA) in people with Skeletal Class III Malocclusion, run by Universidad Complutense de Madrid.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Skeletal Class III Malocclusion
- What is being tested?
- Tooth-Borne Expander with Facemask (FM) and Hybrid Skeletal Anchorage Expander with Chin-Plate (SA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Feb 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 9Show fewer
- Previous orthodontic treatment
- Craniofacial malformations or syndromes
- Systemic diseases or medications affecting growth or bone metabolism
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Skeletal and Dentoalveolar Effects of Tooth-borne Facemask Versus Skeletal Anchorage Chin-plate Maxillary Protraction in Growing Class III Patients.
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.
Read the 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
- Skeletal Class III Malocclusion
- Being tested
- Tooth-Borne Expander with Facemask (FM), Hybrid Skeletal Anchorage Expander with Chin-Plate (SA)
- Keywords
- Class III malocclusion, skeletal anchorage, face-mask, Palatal expander, tooth-borne rapid maxillary expander, hybrid skeletal anchorage expander, chin-plate
- Medical subject headings
- Malocclusion, Angle Class III
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Tooth-Borne Expander with Facemask (FM) |
| 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. Receives: Device: Hybrid Skeletal Anchorage Expander with Chin-Plate (SA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sagittal skeletal relationship
Changes in the cephalometric angles SNA, ANB, and Wits appraisal measured on lateral cephalograms between T0 and T1
Measured: From baseline (T0) through study completion, an average of 1 year (T1)
Secondary outcomes (3)
Cephalometric vertical skeletal changes
- 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
Measured: From baseline (T0) through study completion, an average of 1 year (T1)
Cephalometric dentoalveolar changes
- 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)
Measured: From baseline (T0) through study completion, an average of 1 year (T1)
Treatment duration
- Time elapsed between T0 and T1
Measured: From baseline (T0) through study completion, an average of 1 year (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skeletal Class III MalocclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A retrospective non-randomized controlled clinical trial
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Ortoestetic (https://ortoestetic.com)
- Responsible party
- Principal investigator, Concepción Martín Alvaro, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07383259
- Sponsor's protocol ID
- Mentoplac_FaceMask
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Upon request
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skeletal and Dentoalveolar Effects of Tooth-borne Facemask Versus Skeletal Anchorage Chin-plate Maxillary Protraction in Growing Class III Patients.
- ClinicalTrials.gov ID
- NCT07383259
- Acronym / sponsor ID
- Mentoplac_FaceMask
- Conditions
- Skeletal Class III Malocclusion
- Keywords
- Class III malocclusion, skeletal anchorage, face-mask, Palatal expander, tooth-borne rapid maxillary expander, hybrid skeletal anchorage expander, chin-plate
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Collaborators
- Ortoestetic (https://ortoestetic.com)
- Study start
- Feb 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 3 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A retrospective non-randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Tooth-Borne Expander with Facemask (FM) | Active comparator | 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. |
| Hybrid Skeletal Anchorage Expander with Chin-Plate (SA) | Experimental | 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. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Tooth-Borne Expander with Facemask (FM) |
| 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. | Device | Hybrid Skeletal Anchorage Expander with Chin-Plate (SA) |
Primary outcome
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
3 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: Undecided. Upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Tooth-Borne Expander with Facemask (FM) and Hybrid Skeletal Anchorage Expander with Chin-Plate (SA) in people with Skeletal Class III Malocclusion, run by Universidad Complutense de Madrid.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Beatriz Celis, Postdoc (+34 913941923, beatrizcelisgonzalez@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sagittal skeletal relationship (time frame: From baseline (T0) through study completion, an average of 1 year (T1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.