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Completed

NCT Number: NCT03354442

Treatment of Class III Malocclusion Using Modified Fixed Mandibular Retractor Appliance

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.

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Key information

Age range

7 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Damascus University

Damascus, 00963, Syria

About this study

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.

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 (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.

Treatment and study plan

Modified Fixed Mandibular Retractor Appliance

Device

All patients with Class III malocclusion will be treated using the Modified Fixed Mandibular Retractor Appliance

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2019
First posted
Nov 28, 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.

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