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

NCT02711111 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2016-03-18

No results posted yet for this study

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.

Conditions

  • Maxillary Hypoplasia
  • Malocclusion, Angle Class III

Interventions

DEVICE

Face mask

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

DEVICE

orthodontic bone anchor

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

Sponsors & Collaborators

  • Ziekenhuis Oost-Limburg

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2017-12-31
Completion
2021-12-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02711111 on ClinicalTrials.gov