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Treatment of Class III Malocclusion Using Modified Fixed Mandibular Retractor Appliance

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ClinicalTrials.gov Identifier: NCT03354442
Recruitment Status : Active, not recruiting
First Posted : November 28, 2017
Last Update Posted : February 6, 2018
Sponsor:
Information provided by (Responsible Party):
Damascus University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Malocclusion, Angle Class III Device: Modified Fixed Mandibular Retractor Appliance Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: A person who is not related to the research will paste a piece of paper over the Patient's name and the date of the photo then will give each x-ray a code and blind these codes on the researcher during the assessing process.
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy of Modified Fixed Mandibular Retractor Appliance in the Treatment of Class III Malocclusion: A Clinical Randomized Controlled Trial
Actual Study Start Date : May 15, 2017
Actual Primary Completion Date : December 20, 2017
Estimated Study Completion Date : September 2018

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.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   7 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03354442


Locations
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Syrian Arab Republic
Damascus University
Damascus, Syrian Arab Republic, 00963
Sponsors and Collaborators
Damascus University
Investigators
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Study Chair: Ahmad S Burhan, PhD. Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria

Publications of Results:
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Responsible Party: Damascus University
ClinicalTrials.gov Identifier: NCT03354442     History of Changes
Other Study ID Numbers: UDDS-Ortho-08-2017
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The Individual participant data will be only available for the researchers in the department of Orthodontics, Damascus University

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Damascus University:
Class III treatment
Modified Fixed Mandibular Retractor Appliance
RCT

Additional relevant MeSH terms:
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Malocclusion
Malocclusion, Angle Class III
Prognathism
Tooth Diseases
Stomatognathic Diseases
Jaw Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Mandibular Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities