NCT03354442

Treatment of Class III Malocclusion Using Modified Fixed Mandibular Retractor Appliance

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Damascus University · Academic / Other
• Sex: All
• Age: 7 Years – 9 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Malocclusion, Angle Class III

Interventions

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

Timeline

• Start date: 2017-05-15
• Primary completion: 2017-12-20
• Completion: 2019-01-10
• First posted: 2017-11-28
• Last updated: 2019-07-18

Locations

1 site across 1 country: Syria