Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02711111
Other study ID # MKA Genk
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT02179593 - Effectiveness of SARPE With 3 and 2-Segment Technique: A Randomized Clinical Trial N/A
Not yet recruiting NCT04041388 - Maxillary Segment Tipping During Transpalatal Distraction N/A
Recruiting NCT03757468 - Pain and Discomfort During Maxillary Expansion N/A
Completed NCT05831722 - Changes in the Upper Airway Volume After Rapid Maxillary Expansion in Adults Using Pure Skeletal Anchorage
Recruiting NCT05773573 - Skeletal and Dental Changes With Hyrax-type Rapid Maxillary Expander Anchored to Permanent Versus Deciduous Molars N/A
Completed NCT03570528 - CT Analysis of the Anatomy of the Nasotracheal Intubation Pathway of Patients With Indication of Maxillary Advancement
Completed NCT04225637 - Comparison Between Two Rates of Activation of Miniscrew-Supported Upper Jaw Expander in Adolescents N/A
Completed NCT00930124 - Cleft Orthognathic Surgery Versus Distraction Osteogenesis - Which is Better? Phase 2
Not yet recruiting NCT05899530 - Dentoskeletal Changes Expansion Using Invisalign Versus Conventional Expander N/A
Completed NCT02350803 - Does Use of Rigid Fixation After Removing Distraction Osteogenesis Device Reduce the Relapse? Phase 2
Completed NCT03976609 - Three Dimensional Changes on Nasal Septum and Alveolar Cleft After Maxillary Expansion
Recruiting NCT04190953 - Upper Airway's Pressure Drop Analyses After Mandibular Advancement and Maxillary Expansion N/A
Completed NCT01770782 - Orthodontic Retention on the Maxillary Stability After SARME Using Laser Scanner N/A
Recruiting NCT05543460 - Miniscrew-assisted Rapid Palatal Expansion With and Without Corticopuncture N/A