Skip to main content
OpenTrials
Completed

NCT Number: NCT03172442

Treatment of Skeletal Class III Malocclusion Using Orthodontic Removable Traction Appliance

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Class III Malocclusion Malocclusion Malocclusion, Angle Class III Stomatognathic Diseases Tooth Diseases

Age range

8 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Damascus University

Damascus, 00963, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vacuum plate

Device

Vacuum plate with two hooks between lateral incisor and canine in each side will be applied on the lower arch.

Rapid maxillary expander

Device

Rapid maxillary expander will be applied in the maxilla to disarticulate maxillary sutures to allow more efficient forward protraction of the maxilla.

Class III elastics

Device

Class III elastic traction from upper first molar to the hook in both side will be applied.

Primary outcomes

  1. The change of the ANB angle

    Time frame: Assessment will be done before treatment (T0) and after obtaining 3-mm positive overjet which will be approximately obtained after 6 months (T1).

    The change of the ANB angle before and after using the Orthodontic Removable Traction Appliance compared with this of the control group will be evaluated using lateral cephalometric radiographs.

Secondary outcomes

  1. The change of the SNA angle

    Time frame: Assessment will be done before treatment (T0) and after obtaining 3-mm positive overjet which will be approximately obtained after 6 months (T1).

    The change of the SNA angle before and after using the Orthodontic Removable Traction Appliance compared with this of the control group will be evaluated using lateral cephalometric radiographs.

  2. The change of the SNB angle

    Time frame: Assessment will be done before treatment (T0) and after obtaining 3-mm positive overjet which will be approximately obtained after 6 months (T1).

    The change of the SNB angle before and after using the Orthodontic Removable Traction Appliance compared with this of the control group will be evaluated using lateral cephalometric radiographs.

  3. Levels of pain

    Time frame: A questionnaire will be given to the patients four times during treatment; after 1day, after 1 week, after 1 month and after 3 months of the application of the appliance.

    The level of Pain caused by using the Orthodontic Removable Traction Appliance will be assessed using a questionnaire with a Visual Analog Scale (VAS).

  4. Levels of discomfort

    Time frame: A questionnaire will be given to the patients four times during treatment; after 1day, after 1 week, after 1 month and after 3 months of the application of the appliance.

    The level of discomfort caused by using the Orthodontic Removable Traction Appliance will be assessed using a questionnaire with a Visual Analog Scale (VAS).

  5. Levels of acceptance

    Time frame: A questionnaire will be given to the patients four times during treatment; after 1day, after 1 week, after 1 month and after 3 months of the application of the appliance.

    The level of acceptance of using the Orthodontic Removable Traction Appliance will be assessed using a questionnaire with a Visual Analog Scale (VAS).

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

Dentoskeletal Effects of The Orthodontic Removable Traction Appliance in The Treatment of Skeletal Class III Malocclusion: A Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2017
Study completion
2019
First posted
Jun 1, 2017
Registry last updated
Jul 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.