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

Maxillary Hypoplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02711111
• Other study ID #: MKA Genk
• Status: Not yet recruiting
• Phase: N/A
• First received: March 7, 2016
• Last updated: March 16, 2016
• Start date: April 2016
• Est. completion date: December 2021

Study information

• Verified date: March 2016
• Source: Ziekenhuis Oost-Limburg
• Contact: Joeri Meyns, M.D., D.M.D.
• Phone: +32495471307
• Email: joerimeyns[@]outlook.com
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 2021
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years to 14 Years

Eligibility

Inclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malocclusion
• Malocclusion, Angle Class III
• Maxillary Hypoplasia
• Prognathism

Intervention

Device:
• Face mask
to apply for on the upper jaw (12 - 14 hrs / day) via extra-oral elastics to the face mask
• orthodontic bone anchor
to apply force on the upper jaw (24 / 7) via intra-oral elastics on the bone-anchor

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost Limburg	Genk

Sponsors (1)

Lead Sponsor	Collaborator
Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	complications registration	registration of complications due to the use of the new orthodontic bone anchor (mentoplate)	1 year	No
Secondary	patient satisfaction	registration of the patient satisfaction, easy to use	1 year	No