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Treatment of Skeletal Class III Malocclusion Using Orthodontic Removable Traction Appliance

D

Damascus University

Status

Completed

Conditions

Class III Malocclusion

Treatments

Device: Class III elastics
Device: Vacuum plate
Device: Rapid maxillary expander

Study type

Interventional

Funder types

Other

Identifiers

NCT03172442
UDDS-Ortho-03-2017

Details and patient eligibility

About

This experimental study aims to evaluate the efficiency of the orthodontic removable traction appliance in the treatment of skeletal class III malocclusion. The study sample will consist of 44 patients with skeletal class III malocclusion. The sample will be allocated randomly into two groups: experimental group and control group. The dentoskeletal changes will be assessed by using lateral cephalometric radiographs before treatment and after obtaining 3mm positive overjet.

Full description

Treatment of class III malocclusion is a major challenge in orthodontic contemporary practice, Several appliance have suggested for the treatment of class III malocclusion, such as the facial mask and chin cup.

Despite of the efficiency of this extraoral appliance, its external appearance and its big size reduce patients' cooperation which decrease its clinical effects.

Another Class III treatment modality is the Orthodontic Removable Traction Appliance (ORTA). It is a removable appliance that can be used in conjunction with rapid palatal expansion or fixed appliances, It was developed in the 1980's by Dr. David Musich who developed this appliance in order to overcome issues of compliance that Dr. Musich experienced with use of the protraction facemask.

There is only one study that evaluated this appliance which is a retrospective study compared the treatment effects of the ORTA and protraction facemask in treatment of Class III malocclusions. However, this study has a lot of limitations which made it difficult to accurately evaluate the efficiency of this device.

The aim of this study is studying the dentoskeletal changes that result from treatment by this device, by comparing them to the changes in matched untreated group,by studying the cephalometric x-rays.

Enrollment

22 patients

Sex

All

Ages

8 to 10 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients in early mixed dentation (8-10 years old).
  • Skeletal class III caused by maxillary deficiency with or without mandibular prognathism judged clinically and confirmed radiographically(ANB≤1).
  • Anterior crossbite on two teeth or more or an edge-to-edge bite.
  • Normal inclination of the lower incisors with the mandibular plane.

Exclusion criteria

  • Poor oral hygiene.
  • Previous orthodontic treatment.
  • Patients with syndromes, clefts, or craniofacial abnormalities.
  • Severe skeletal class III primarily resulting from mandibular prognathism (ANB less than - 4)
  • Patients with facial asymmetry.
  • Patients with vertical growth pattern.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

22 participants in 2 patient groups

orthodontic removable traction appliance
Experimental group
Description:
Patients in this group will be treated using the orthodontic removable traction appliance (vacuum plate with two hooks between lateral incisor and canine in each side). An rapid maxillary expander will be applied to disarticulate maxillary sutures to allow more efficient forward protraction of the maxilla. Class III elastic traction from upper first molar to the hook in both side. This appliance will be used full-time with Class III elastics (6- to 8-ounce) traction.
Treatment:
Device: Rapid maxillary expander
Device: Vacuum plate
Device: Class III elastics
Control group
No Intervention group
Description:
without intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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