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

Primary Purpose

Maxillary Hypoplasia, Malocclusion, Angle Class III

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Face mask
orthodontic bone anchor
Sponsored by
Ziekenhuis Oost-Limburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Maxillary Hypoplasia

Eligibility Criteria

7 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Sites / Locations

  • Ziekenhuis Oost Limburg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

orthodontic bone anchor

face mask protraction

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

complications registration
registration of complications due to the use of the new orthodontic bone anchor (mentoplate)
patient satisfaction
registration of the patient satisfaction, easy to use

Full Information

First Posted
March 7, 2016
Last Updated
March 16, 2016
Sponsor
Ziekenhuis Oost-Limburg
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1. Study Identification

Unique Protocol Identification Number
NCT02711111
Brief Title
Effect of Bone-anchored Protraction on Maxillary Growth in the Young Child
Official Title
Effect of Bone-anchored Protraction on Maxillary Growth in the Young Child
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ziekenhuis Oost-Limburg

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maxillary Hypoplasia, Malocclusion, Angle Class III

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
orthodontic bone anchor
Arm Type
Experimental
Arm Description
new bone anchor device, which creates anterior traction on the upper jaw. Placed on the chin-region intra-orally.
Arm Title
face mask protraction
Arm Type
Active Comparator
Arm Description
control group, conventional treatment method. Face mask creates anterior traction on the upper jaw
Intervention Type
Device
Intervention Name(s)
Face mask
Other Intervention Name(s)
face mask of dealer
Intervention Description
to apply for on the upper jaw (12 - 14 hrs / day) via extra-oral elastics to the face mask
Intervention Type
Device
Intervention Name(s)
orthodontic bone anchor
Other Intervention Name(s)
mentoplate, PSM medical solutions, Tuttlingen, Germany
Intervention Description
to apply force on the upper jaw (24 / 7) via intra-oral elastics on the bone-anchor
Primary Outcome Measure Information:
Title
effect of bone-anchored protraction on maxillary growth in the young child, 1 year with 3D analysis
Description
assessment of anterior growth of the upper jaw, 1 year after start of treatment
Time Frame
1 year
Title
effect of bone-anchored protraction on maxillary growth in the young child, 5 years, with 3D analysis
Description
assessment of anterior growth of the upper jaw, 5 years after start of treatment
Time Frame
5 years
Secondary Outcome Measure Information:
Title
complications registration
Description
registration of complications due to the use of the new orthodontic bone anchor (mentoplate)
Time Frame
1 year
Title
patient satisfaction
Description
registration of the patient satisfaction, easy to use
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: healthy subjects 7 - 14 years old Class III occlusion maxillary hypoplasia good oral hygiene no craniofacial syndrome
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joeri Meyns, M.D., D.M.D.
Phone
+32495471307
Email
joerimeyns@outlook.com
First Name & Middle Initial & Last Name or Official Title & Degree
Luc Vrielinck, M.D., D.M.D.
Phone
+3289326161
Email
luc@vrielinck.be
Facility Information:
Facility Name
Ziekenhuis Oost Limburg
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joeri Meyns, M.D., D.M.D.
Phone
+32495471307

12. IPD Sharing Statement

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

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