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

East Limburg Hospital

Status: Unknown

Conditions: Malocclusion, Angle Class III; Maxillary Hypoplasia

Treatments: Device: Face mask; Device: orthodontic bone anchor

Study type: Interventional

Funder types: Other

Identifiers

NCT02711111

MKA Genk

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 7 to 14 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

orthodontic bone anchor

Experimental group

Description:

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

Treatment:

Device: orthodontic bone anchor

face mask protraction

Active Comparator group

Description:

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

Treatment:

Device: Face mask