Maxillary HypoplasiaNCT02711111
Effect of Bone-anchored Protraction on Maxillary Growth in the Young Child
A study testing Face mask and orthodontic bone anchor in people with Maxillary Hypoplasia and Malocclusion, Angle Class III, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
Trial summary
Class III malocclusions may originate in a retrognathic maxilla, a prognathic mandible or both. Young patients with class III malocclusion and maxillary hypoplasia are conventionally treated with a protraction facemask in order to stimulate forward growth of the upper jaw. Read more about this study
- Who is it for?
- Ages 7 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Maxillary Hypoplasia, Malocclusion, Angle Class III
- What is being tested?
- Face mask and orthodontic bone anchor
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2016to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 7 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy subjects 7 - 14 years old Class III occlusion maxillary hypoplasia good oral hygiene no craniofacial syndrome
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Ziekenhuis Oost Limburg
Genk, 3600
Joeri Meyns, M.D., D.M.D., +32495471307
About this study
Class III malocclusions may originate in a retrognathic maxilla, a prognathic mandible or both. Young patients with class III malocclusion and maxillary hypoplasia are conventionally treated with a protraction facemask in order to stimulate forward growth of the upper jaw. This treatment option is often inducing unwanted side effects including mesial migration of the teeth in the upper jaw and clockwise rotation of the mandible. Because skeletal effects are often difficult to achieve with this approach, more pronounced class III malocclusions cannot be addressed by face mask therapy. These children cannot be treated during childhood and end up in major orthognathic surgery at full-grown age. To be able to treat also the more pronounced class III malocclusion and to minimize dentoalveolar compensations new treatment methods were developed which uses skeletal anchorage.
Read the detailed description
Rationale:
Class III malocclusions may originate in a retrognathic maxilla, a prognathic mandible or both. Young patients with class III malocclusion and maxillary hypoplasia are conventionally treated with a protraction facemask or reverse twin block appliance in order to stimulate forward growth of the upper jaw. This treatment option is often inducing unwanted side effects including mesial migration of the teeth in the upper jaw and clockwise rotation of the mandible. Because skeletal effects are often difficult to achieve with this approach, more pronounced class III malocclusions cannot be addressed by face mask therapy. These children cannot be treated during childhood and end up in major orthognathic surgery at full-grown age.
To be able to treat also the more pronounced class III malocclusion and to minimize dentoalveolar compensations new treatment methods were developed which uses skeletal anchorage. In maxillary deficiency cases it's common to have the deficiency anteroposteriorly as well as transversely. Opening of the midpalatal suture by rapid expansion can correct the transverse hypoplasia and may produce more anterior movement of the maxilla. The proposed technique enables to start skeletal anchorage treatment at an earlier age, which also has the potential of more growth modification during treatment.
Objective:
To compare a new technique of skeletal traction with incorporation of maxillary expansion to conventional treatment protocols.
Study design:
This is a RCT
Study population:
Healthy human volunteers (7- 14 yrs old) with class III malocclusion due to maxillary deficiency.
Intervention:
The intervention consists of the application of a mentoplate (anchored with screws to the bone) in the lower jaw and two screws in the upper jaw (palate). Expansion in the upper jaw is achieved by a classic Hyrax appliance, connected to these screws. Anterior movement of the maxilla is subsequently accomplished by intermaxillary elastic traction to the mentoplate.
Control group (conventional treatment):
Anterior movement of the maxilla accomplished by elastic traction to a face mask
Main study parameters/endpoints:
The main study parameter is the difference in the amount of forward growth of the upper jaw and mid-face (measured with a cone beam CT) compared to the growth that is observed with conventional treatment.
A cone beam CT will be made before the start of traction therapy (baseline) and after 1 year of therapy to evaluate the amount of expansion and forward growth of the maxilla.
One last cone beam CT will be produced at the end of growth, 5 years after start of the orthodontic traction, to evaluate the long-term stability of the obtained advancement.
Other end-points will be patients' satisfaction and complication-rate.
- Being tested
- Face mask, orthodontic bone anchor
- Medical subject headings
- Retrognathia, Malocclusion, Angle Class III
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face maskDevice
Also called face mask of dealer
to apply for on the upper jaw (12 - 14 hrs / day) via extra-oral elastics to the face mask
orthodontic bone anchorDevice
Also called mentoplate, PSM medical solutions, Tuttlingen, Germany
to apply force on the upper jaw (24 / 7) via intra-oral elastics on the bone-anchor
| Study group | Role | What they receive |
|---|---|---|
| orthodontic bone anchor | Experimental | new bone anchor device, which creates anterior traction on the upper jaw. Placed on the chin-region intra-orally. Receives: Device: orthodontic bone anchor |
| face mask protraction | Active comparator | control group, conventional treatment method. Face mask creates anterior traction on the upper jaw Receives: Device: Face mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of bone-anchored protraction on maxillary growth in the young child, 1 year with 3D analysis
assessment of anterior growth of the upper jaw, 1 year after start of treatment
Measured: 1 year
effect of bone-anchored protraction on maxillary growth in the young child, 5 years, with 3D analysis
assessment of anterior growth of the upper jaw, 5 years after start of treatment
Measured: 5 years
Secondary outcomes (2)
complications registration
registration of complications due to the use of the new orthodontic bone anchor (mentoplate)
Measured: 1 year
patient satisfaction
registration of the patient satisfaction, easy to use
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Maxillary HypoplasiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziekenhuis Oost-Limburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joeri Meyns, Ziekenhuis Oost-Limburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02711111
- Sponsor's protocol ID
- MKA Genk
- Status last verified
- Mar 2016
- First submitted
- 7 Mar 2016
- Last updated
- 18 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Meyns J, Meewis J, Dons F, Schreurs A, Aerts J, Shujaat S, Politis C, Jacobs R. Long-term comparison of maxillary protraction with hybrid hyrax-facemask vs. hybrid hyrax-mentoplate protocols using Alt-RAMEC: a 5-year randomized controlled trial. Eur J Orthod. 2025 Feb 7;47(2):cjaf011. doi: 10.1093/ejo/cjaf011.
PubMed 40105065
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bone-anchored Protraction on Maxillary Growth in the Young Child
- ClinicalTrials.gov ID
- NCT02711111
- Acronym / sponsor ID
- MKA Genk
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ziekenhuis Oost-LimburgUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 17 Mar 2016 (estimated)
- 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.
Class III malocclusions may originate in a retrognathic maxilla, a prognathic mandible or both. Young patients with class III malocclusion and maxillary hypoplasia are conventionally treated with a protraction facemask in order to stimulate forward growth of the upper jaw. This treatment option is often inducing unwanted side effects including mesial migration of the teeth in the upper jaw and clockwise rotation of the mandible. Because skeletal effects are often difficult to achieve with this approach, more pronounced class III malocclusions cannot be addressed by face mask therapy. These children cannot be treated during childhood and end up in major orthognathic surgery at full-grown age. To be able to treat also the more pronounced class III malocclusion and to minimize dentoalveolar compensations new treatment methods were developed which uses skeletal anchorage.
Detailed description
Rationale:
Class III malocclusions may originate in a retrognathic maxilla, a prognathic mandible or both. Young patients with class III malocclusion and maxillary hypoplasia are conventionally treated with a protraction facemask or reverse twin block appliance in order to stimulate forward growth of the upper jaw. This treatment option is often inducing unwanted side effects including mesial migration of the teeth in the upper jaw and clockwise rotation of the mandible. Because skeletal effects are often difficult to achieve with this approach, more pronounced class III malocclusions cannot be addressed by face mask therapy. These children cannot be treated during childhood and end up in major orthognathic surgery at full-grown age.
To be able to treat also the more pronounced class III malocclusion and to minimize dentoalveolar compensations new treatment methods were developed which uses skeletal anchorage. In maxillary deficiency cases it's common to have the deficiency anteroposteriorly as well as transversely. Opening of the midpalatal suture by rapid expansion can correct the transverse hypoplasia and may produce more anterior movement of the maxilla. The proposed technique enables to start skeletal anchorage treatment at an earlier age, which also has the potential of more growth modification during treatment.
Objective:
To compare a new technique of skeletal traction with incorporation of maxillary expansion to conventional treatment protocols.
Study design:
This is a RCT
Study population:
Healthy human volunteers (7- 14 yrs old) with class III malocclusion due to maxillary deficiency.
Intervention:
The intervention consists of the application of a mentoplate (anchored with screws to the bone) in the lower jaw and two screws in the upper jaw (palate). Expansion in the upper jaw is achieved by a classic Hyrax appliance, connected to these screws. Anterior movement of the maxilla is subsequently accomplished by intermaxillary elastic traction to the mentoplate.
Control group (conventional treatment):
Anterior movement of the maxilla accomplished by elastic traction to a face mask
Main study parameters/endpoints:
The main study parameter is the difference in the amount of forward growth of the upper jaw and mid-face (measured with a cone beam CT) compared to the growth that is observed with conventional treatment.
A cone beam CT will be made before the start of traction therapy (baseline) and after 1 year of therapy to evaluate the amount of expansion and forward growth of the maxilla.
One last cone beam CT will be produced at the end of growth, 5 years after start of the orthodontic traction, to evaluate the long-term stability of the obtained advancement.
Other end-points will be patients' satisfaction and complication-rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| orthodontic bone anchor | Experimental | Device: orthodontic bone anchornew bone anchor device, which creates anterior traction on the upper jaw. Placed on the chin-region intra-orally. |
| face mask protraction | Active comparator | Device: Face maskcontrol group, conventional treatment method. Face mask creates anterior traction on the upper jaw |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- healthy subjects 7 - 14 years old Class III occlusion maxillary hypoplasia good oral hygiene no craniofacial syndrome
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 |
|---|---|---|
| Face maskAlso: face mask of dealerto apply for on the upper jaw (12 - 14 hrs / day) via extra-oral elastics to the face mask | Device | face mask protraction |
| orthodontic bone anchorAlso: mentoplate, PSM medical solutions, Tuttlingen, Germanyto apply force on the upper jaw (24 / 7) via intra-oral elastics on the bone-anchor | Device | orthodontic bone anchor |
Primary outcome
effect of bone-anchored protraction on maxillary growth in the young child, 1 year with 3D analysis
Time frame: 1 year
assessment of anterior growth of the upper jaw, 1 year after start of treatment
effect of bone-anchored protraction on maxillary growth in the young child, 5 years, with 3D analysis
Time frame: 5 years
assessment of anterior growth of the upper jaw, 5 years after start of treatment
2 secondary outcomes
complications registration
Time frame: 1 year
patient satisfaction
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2016.
- Derived from this study: PubMed 40105065Meyns J, Meewis J, Dons F, Schreurs A, Aerts J, Shujaat S, Politis C, Jacobs R. Long-term comparison of maxillary protraction with hybrid hyrax-facemask vs. hybrid hyrax-mentoplate protocols using Alt-RAMEC: a 5-year randomized controlled trial. Eur J Orthod. 2025 Feb 7;47(2):cjaf011. doi: 10.1093/ejo/cjaf011.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face mask and orthodontic bone anchor in people with Maxillary Hypoplasia and Malocclusion, Angle Class III, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
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 1 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: status not confirmed, as of the sponsor's last update on 18 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joeri Meyns, M.D., D.M.D. (+32495471307, joerimeyns@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effect of bone-anchored protraction on maxillary growth in the young child, 1 year with 3D analysis (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02711111, which also lists 1 linked publication.
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 18 Mar 2016; AzTrials last refreshed its copy on 6 Nov 2026.