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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02711111
Enrollment
20
Registered
2016-03-17
Start date
2016-04-30
Completion date
2021-12-31
Last updated
2016-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maxillary Hypoplasia, Malocclusion, Angle Class III

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.

Interventions

DEVICEFace mask

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

DEVICEorthodontic bone anchor

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

Sponsors

Ziekenhuis Oost-Limburg
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
7 Years to 14 Years
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
effect of bone-anchored protraction on maxillary growth in the young child, 1 year with 3D analysis1 yearassessment of anterior growth of the upper jaw, 1 year after start of treatment
effect of bone-anchored protraction on maxillary growth in the young child, 5 years, with 3D analysis5 yearsassessment of anterior growth of the upper jaw, 5 years after start of treatment

Secondary

MeasureTime frameDescription
complications registration1 yearregistration of complications due to the use of the new orthodontic bone anchor (mentoplate)
patient satisfaction1 yearregistration of the patient satisfaction, easy to use

Countries

Belgium

Contacts

Primary ContactJoeri Meyns, M.D., D.M.D.
joerimeyns@outlook.com+32495471307
Backup ContactLuc Vrielinck, M.D., D.M.D.
luc@vrielinck.be+3289326161

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026