Treatment of Class III Malocclusion Using Modified Fixed Mandibular Retractor Appliance

July 16, 2019 updated by: Damascus University

Evaluation of the Efficacy of Modified Fixed Mandibular Retractor Appliance in the Treatment of Class III Malocclusion: A Clinical Randomized Controlled Trial

This experimental study aims to evaluate the efficiency of the Modified Fixed Mandibular Retractor 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 untreated control group.

The soft and hard tissue changes will be assessed using lateral cephalometric radiographs before the treatment and after obtaining 3mm positive overjet.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This research aimes to evaluate the effects of a Class III functional appliance [the modified fixed mandibular retractor (MFMR)] in the early treatment of skeletal Class III deformities.

It was not ethical to expose all candidate children to radiographic examination. Therefore, the assessment of skeletal Class III malocclusion was based on clinical judgment. Each patient was examined, while his/her mandible was kept at its retruded contact position to evaluate both jaws in space. Those who met the inclusion criteria were then sent to the radiographic department.

The radiographic lateral cephalograms were obtained in the patients' habitual occlusion.

All patients in the treatment group were treated by one specialist orthodontist 'AA' using the MFMR. The appliance consisted of the following elements: (1) Two acrylic upper posterior bite planes which cover the deciduous and permanent molars ( 2) Two transpalatal arch (0.8-mm TMA) with opposite U loop, the anterior one is near the first deciduous molars while the posterior one is near the first permanent molars (3) upper reversed labial bow (0.9-mm stainless steel) extending to the cervical edges of the mandibular anterior teeth from the labial surface of the lower primary canine on one side to the other labial surface of the contralateral tooth. This bow will be activated to hold the mandible in its maximum posterior physiologic position; and (4) the anterior spring (0.8-mm TMA) which starts from the acrylic bite plane in both sides, makes loop, then bends to touch the cingulum of upper incisors to procline the upper permanent incisors when diagnosed as retroclined.

The untreated group will receive no orthodontic treatment during the observation period. According to the Dental School Local Research Ethics Committee's guidelines, all children in the untreated group will receive orthodontic treatment after the end of the observational period of the study at no cost.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 9 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients in early mixed dentation (7-9 years old).
  • Skeletal class III caused by mandibular prognathism with or without maxillary deficiency judged clinically and confirmed radiographically (ANB≤1).
  • Anterior crossbite on two teeth or more.
  • Normal inclination of the lower incisors with the mandibular plane.
  • Good oral hygiene.

Exclusion Criteria:

  • Poor oral hygiene.
  • Previous orthodontic treatment.
  • Patients with syndromes, clefts, or craniofacial abnormalities.
  • Severe skeletal class III resulting primarily from mandibular prognathism (ANB less than - 4 with no functional shift on closure)
  • Patients with facial asymmetry.
  • Patients with vertical growth pattern.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Modified Fixed Mandibular Retractor
All patients in this group will be treated using Modified Fixed Mandibular Retractor Appliance. This appliance will be used full-time.
Device: Modified Fixed Mandibular Retractor Appliance
All patients with Class III malocclusion will be treated using the Modified Fixed Mandibular Retractor Appliance
NO_INTERVENTION: Untreated control group
All patients in this group will be observed during the period of treating the patients in the other group to assess the growth changes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ANB angle changes
Time Frame: Changes will be evaluated before treatment and after obtaining 3mm positive overjet, which will take approximately 8 months
ANB angle changes before and after treatment will be assessed and compared with those of the control group using lateral cephalometric radiographs.
Changes will be evaluated before treatment and after obtaining 3mm positive overjet, which will take approximately 8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SNA angle changes
Time Frame: Changes will be evaluated before treatment and after obtaining 3mm positive overjet, which will take approximately 8 months
SNA angle changes before and after treatment will be assessed and compared with those of the control group using lateral cephalometric radiographs.
Changes will be evaluated before treatment and after obtaining 3mm positive overjet, which will take approximately 8 months
SNB angle changes
Time Frame: Changes will be evaluated before treatment and after obtaining 3mm positive overjet, which will take approximately 8 months
SNB angle changes before and after treatment will be assessed and compared with those of the control group using lateral cephalometric radiographs.
Changes will be evaluated before treatment and after obtaining 3mm positive overjet, which will take approximately 8 months
Profile changes
Time Frame: Changes will be evaluated before treatment and after obtaining 3mm positive overjet, which will take approximately 8 months
Profile changes before and after treatment will be assessed and compared with those of the control group using lateral cephalometric radiographs.
Changes will be evaluated before treatment and after obtaining 3mm positive overjet, which will take approximately 8 months
Upper incisor angle changes
Time Frame: Changes will be evaluated before treatment and after obtaining 3mm positive overjet, which will take approximately 8 months
Upper incisor angle changes before and after treatment will be assessed and compared with those of the control group using lateral cephalometric radiographs.
Changes will be evaluated before treatment and after obtaining 3mm positive overjet, which will take approximately 8 months
Lower incisor angle changes
Time Frame: Changes will be evaluated before treatment and after obtaining 3mm positive overjet, which will take approximately 8 months
Lower incisor angle changes before and after treatment will be assessed and compared with those of the control group using lateral cephalometric radiographs.
Changes will be evaluated before treatment and after obtaining 3mm positive overjet, which will take approximately 8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damascus University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 15, 2017

Primary Completion (ACTUAL)

December 20, 2017

Study Completion (ACTUAL)

January 10, 2019

Study Registration Dates

First Submitted

November 15, 2017

First Submitted That Met QC Criteria

November 27, 2017

First Posted (ACTUAL)

November 28, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 18, 2019

Last Update Submitted That Met QC Criteria

July 16, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDDS-Ortho-08-2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The Individual participant data will be only available for the researchers in the department of Orthodontics, Damascus University

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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