Treatment of Class III Malocclusion Using Modified Fixed Mandibular Retractor Appliance
Primary Purpose
Malocclusion, Angle Class III
Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Modified Fixed Mandibular Retractor Appliance
Sponsored by
About this trial
This is an interventional treatment trial for Malocclusion, Angle Class III focused on measuring Class III treatment, Modified Fixed Mandibular Retractor Appliance, RCT
Eligibility 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.
Sites / Locations
- Damascus University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Modified Fixed Mandibular Retractor
Untreated control group
Arm Description
All patients in this group will be treated using Modified Fixed Mandibular Retractor Appliance. This appliance will be used full-time.
All patients in this group will be observed during the period of treating the patients in the other group to assess the growth changes.
Outcomes
Primary Outcome Measures
ANB angle changes
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
SNA angle changes
SNA angle changes before and after treatment will be assessed and compared with those of the control group using lateral cephalometric radiographs.
SNB angle changes
SNB angle changes before and after treatment will be assessed and compared with those of the control group using lateral cephalometric radiographs.
Profile changes
Profile changes before and after treatment will be assessed and compared with those of the control group using lateral cephalometric radiographs.
Upper incisor angle changes
Upper incisor angle changes before and after treatment will be assessed and compared with those of the control group using lateral cephalometric radiographs.
Lower incisor angle changes
Lower incisor angle changes before and after treatment will be assessed and compared with those of the control group using lateral cephalometric radiographs.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03354442
Brief Title
Treatment of Class III Malocclusion Using Modified Fixed Mandibular Retractor Appliance
Official Title
Evaluation of the Efficacy of Modified Fixed Mandibular Retractor Appliance in the Treatment of Class III Malocclusion: A Clinical Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
May 15, 2017 (Actual)
Primary Completion Date
December 20, 2017 (Actual)
Study Completion Date
January 10, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion, Angle Class III
Keywords
Class III treatment, Modified Fixed Mandibular Retractor Appliance, RCT
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Modified Fixed Mandibular Retractor
Arm Type
Experimental
Arm Description
All patients in this group will be treated using Modified Fixed Mandibular Retractor Appliance. This appliance will be used full-time.
Arm Title
Untreated control group
Arm Type
No Intervention
Arm Description
All patients in this group will be observed during the period of treating the patients in the other group to assess the growth changes.
Intervention Type
Device
Intervention Name(s)
Modified Fixed Mandibular Retractor Appliance
Intervention Description
All patients with Class III malocclusion will be treated using the Modified Fixed Mandibular Retractor Appliance
Primary Outcome Measure Information:
Title
ANB angle changes
Description
ANB angle changes before and after treatment will be assessed and compared with those of the control group using lateral cephalometric radiographs.
Time Frame
Changes will be evaluated before treatment and after obtaining 3mm positive overjet, which will take approximately 8 months
Secondary Outcome Measure Information:
Title
SNA angle changes
Description
SNA angle changes before and after treatment will be assessed and compared with those of the control group using lateral cephalometric radiographs.
Time Frame
Changes will be evaluated before treatment and after obtaining 3mm positive overjet, which will take approximately 8 months
Title
SNB angle changes
Description
SNB angle changes before and after treatment will be assessed and compared with those of the control group using lateral cephalometric radiographs.
Time Frame
Changes will be evaluated before treatment and after obtaining 3mm positive overjet, which will take approximately 8 months
Title
Profile changes
Description
Profile changes before and after treatment will be assessed and compared with those of the control group using lateral cephalometric radiographs.
Time Frame
Changes will be evaluated before treatment and after obtaining 3mm positive overjet, which will take approximately 8 months
Title
Upper incisor angle changes
Description
Upper incisor angle changes before and after treatment will be assessed and compared with those of the control group using lateral cephalometric radiographs.
Time Frame
Changes will be evaluated before treatment and after obtaining 3mm positive overjet, which will take approximately 8 months
Title
Lower incisor angle changes
Description
Lower incisor angle changes before and after treatment will be assessed and compared with those of the control group using lateral cephalometric radiographs.
Time Frame
Changes will be evaluated before treatment and after obtaining 3mm positive overjet, which will take approximately 8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmad S Burhan, PhD.
Organizational Affiliation
Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria
Official's Role
Study Chair
Facility Information:
Facility Name
Damascus University
City
Damascus
ZIP/Postal Code
00963
Country
Syrian Arab Republic
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The Individual participant data will be only available for the researchers in the department of Orthodontics, Damascus University
Citations:
PubMed Identifier
17315814
Citation
Alhaija ES. Skeletal, dental and soft tissue changes in postural class III malocclusion treated with a maxillary removable appliance. J Clin Pediatr Dent. 2006 Winter;31(2):149-52. doi: 10.17796/jcpd.31.2.u286433up81kt472.
Results Reference
background
PubMed Identifier
26446505
Citation
Akin M, Ucar FI, Chousein C, Sari Z. Effects of chincup or facemask therapies on the orofacial airway and hyoid position in Class III subjects. J Orofac Orthop. 2015 Nov;76(6):520-30. doi: 10.1007/s00056-015-0315-3.
Results Reference
background
PubMed Identifier
27443361
Citation
Majanni AM, Hajeer MY. The Removable Mandibular Retractor vs the Bone-anchored Intermaxillary Traction in the Correction of skeletal class III Malocclusion in children: A Randomized Controlled Trial. J Contemp Dent Pract. 2016 May 1;17(5):361-71. doi: 10.5005/jp-journals-10024-1856.
Results Reference
background
PubMed Identifier
21806467
Citation
Seehra J, Fleming PS, Mandall N, Dibiase AT. A comparison of two different techniques for early correction of Class III malocclusion. Angle Orthod. 2012 Jan;82(1):96-101. doi: 10.2319/032011-197.1. Epub 2011 Aug 1.
Results Reference
background
PubMed Identifier
20348164
Citation
Atalay Z, Tortop T. Dentofacial effects of a modified tandem traction bow appliance. Eur J Orthod. 2010 Dec;32(6):655-61. doi: 10.1093/ejo/cjp153. Epub 2010 Mar 26.
Results Reference
background
PubMed Identifier
18923222
Citation
Kapur A, Chawla HS, Utreja A, Goyal A. Early class III occlusal tendency in children and its selective management. J Indian Soc Pedod Prev Dent. 2008 Sep;26(3):107-13. doi: 10.4103/0970-4388.43191.
Results Reference
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Treatment of Class III Malocclusion Using Modified Fixed Mandibular Retractor Appliance
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