Effect of Bone-anchored Protraction on Maxillary Growth in the Young Child

NCT ID: NCT02711111

Last Updated: 2016-03-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2021-12-31

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.

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.

Conditions

Maxillary Hypoplasia; Malocclusion, Angle Class III

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

orthodontic bone anchor

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

Group Type: EXPERIMENTAL

orthodontic bone anchor

Intervention Type: DEVICE

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

face mask protraction

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

Group Type: ACTIVE_COMPARATOR

Face mask

Intervention Type: DEVICE

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

Interventions

Face mask

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

Intervention Type: DEVICE

orthodontic bone anchor

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

Intervention Type: DEVICE

Other Intervention Names

face mask of dealer; mentoplate, PSM medical solutions, Tuttlingen, Germany

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ziekenhuis Oost-Limburg

OTHER

Sponsor Role: lead

Responsible Party

Joeri Meyns

J. Meyns, M.D., D.M.D., oral and maxillofacial Surgery, principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ziekenhuis Oost Limburg

Genk, , Belgium

Countries

Belgium

Central Contacts

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

Role: CONTACT

joerimeyns@outlook.com

+32495471307

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

Role: CONTACT

luc@vrielinck.be

+3289326161

Facility Contacts

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

Role: primary

+32495471307

References

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.

Reference Type: DERIVED

PMID: 40105065 (View on PubMed)

Other Identifiers

MKA Genk

Identifier Type: -

Identifier Source: org_study_id