NCT02711111

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 17, 2016

Completed
15 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

March 18, 2016

Status Verified

March 1, 2016

Enrollment Period

1.7 years

First QC Date

March 7, 2016

Last Update Submit

March 16, 2016

Conditions

Maxillary HypoplasiaMalocclusion, Angle Class III

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    5 years

Secondary Outcomes (2)

  • complications registration

    1 year

  • patient satisfaction

    1 year

Study Arms (2)

orthodontic bone anchor

EXPERIMENTAL

new bone anchor device, which creates anterior traction on the upper jaw. Placed on the chin-region intra-orally.

Device: orthodontic bone anchor

face mask protraction

ACTIVE COMPARATOR

control group, conventional treatment method. Face mask creates anterior traction on the upper jaw

Device: Face mask

Interventions

Face maskDEVICE

to apply for on the upper jaw (12 - 14 hrs / day) via extra-oral elastics to the face mask

Also known as: face mask of dealer
face mask protraction
orthodontic bone anchorDEVICE

to apply force on the upper jaw (24 / 7) via intra-oral elastics on the bone-anchor

Also known as: mentoplate, PSM medical solutions, Tuttlingen, Germany
orthodontic bone anchor

Eligibility Criteria

Age7 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • healthy subjects 7 - 14 years old Class III occlusion maxillary hypoplasia good oral hygiene no craniofacial syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ziekenhuis Oost Limburg

Genk, 3600, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 40105065DERIVED

MeSH Terms

Conditions

RetrognathiaMalocclusion, Angle Class III

Interventions

Masks

Condition Hierarchy (Ancestors)

Jaw AbnormalitiesJaw DiseasesMusculoskeletal DiseasesMaxillofacial AbnormalitiesCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesStomatognathic DiseasesMandibular DiseasesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMalocclusionTooth Diseases

Intervention Hierarchy (Ancestors)

Surgical AttireEquipment and Supplies, HospitalEquipment and SuppliesProtective DevicesPersonal Protective EquipmentSurgical EquipmentManufactured MaterialsTechnology, Industry, and Agriculture

Central Study Contacts

Joeri Meyns, M.D., D.M.D.

CONTACT

+32495471307joerimeyns@outlook.com

Luc Vrielinck, M.D., D.M.D.

CONTACT

+3289326161luc@vrielinck.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
J. Meyns, M.D., D.M.D., oral and maxillofacial Surgery, principal investigator

Study Record Dates

First Submitted

March 7, 2016

First Posted

March 17, 2016

Study Start

April 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2021

Last Updated

March 18, 2016

Record last verified: 2016-03

Locations

BE(1)