An interventional study of Modified Fixed Mandibular Retractor Appliance in Malocclusion, Angle Class III, sponsored by Damascus University. Completed at 1 site in Syrian Arab Republic. Open to participants aged 7 Years to 9 Years. Per ClinicalTrials.gov, last updated 2019-07-18.
Sponsored by Damascus University · Not applicable, Interventional, and Treatment
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.
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.
57 studies on the registry are indexed under Malocclusion, Angle Class III; 11 are open to participants now.
This study's enrollment of 44 is above the median of 32 across 53 interventional studies indexed under Malocclusion, Angle Class III.
Browse Malocclusion, Angle Class III studies →Damascus University is the lead sponsor of 212 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
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 in this group will be observed during the period of treating the patients in the other group to assess the growth changes.
All patients with Class III malocclusion will be treated using the Modified Fixed Mandibular Retractor Appliance
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.
Time frame: Changes will be evaluated before treatment and after obtaining 3mm positive overjet, which will take approximately 8 months
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.
Time frame: Changes will be evaluated before treatment and after obtaining 3mm positive overjet, which will take approximately 8 months
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.
Time frame: Changes will be evaluated before treatment and after obtaining 3mm positive overjet, which will take approximately 8 months
Profile changes
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
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.
Time frame: Changes will be evaluated before treatment and after obtaining 3mm positive overjet, which will take approximately 8 months
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.
Time frame: Changes will be evaluated before treatment and after obtaining 3mm positive overjet, which will take approximately 8 months
Plan to share: No — The Individual participant data will be only available for the researchers in the department of Orthodontics, Damascus University
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Malocclusion, Angle Class III →