An interventional study of MARA appliance and fixed twin block in Class II Malocclusion and Mandibular Deficiency, sponsored by Mansoura University. Recruiting at 1 site in Egypt. Open to participants aged 9 Years to 14 Years. Per ClinicalTrials.gov, last updated 2026-01-14.
Sponsored by Mansoura University · Not applicable, Interventional, and Treatment
Objective: to evaluate the dentoskeletal effects of CAD/CAM 3D-Printed fixed twin block versus MARA appliances in the management of skeletal class II due to Mandibular Deficiency in Preadolescence Class II malocclusion is considered one of the most commonly observed problems among orthodontic patients, representing around one-third of the patients seeking orthodontic treatment reflecting a significant economic impact. Various removable and fixed functional appliances are commonly used to stimulate mandibular growth. Fixed Twin-block appliance has advantages compared with removable Twin-block and Herbst appliances. The mandibular anterior repositioning appliance is referred to as M.A.R.A. appliance.
Materials and method: The study design is a randomized controlled trial in which the control group and intervention groups will be assessed as parallel groups with a 1:1:1 allocation ratio. Sixty subjects will be enrolled in this research. They will be divided equally into three groups: untreated control, MARA group and Twin block group
26 studies on the registry are indexed under Micrognathism; 7 are open to participants now.
This study's planned enrollment of 60 is above the median of 24 across 22 interventional studies indexed under Micrognathism.
Browse Micrognathism studies →Mansoura University is the lead sponsor of 1,119 studies on the registry; 183 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Device: MARA appliance
Device: fixed twin block
CAD/CAM 3D printed mandibular anterior repositioning appliance
CAD/CAM 3D printed fixed twin block
Linear Skeletal changes of the maxilla and mandible using cephalometric measurements
linear (mm) measurement
Time frame: From date of randomization until the date of first documented acceptable correction assessed up to 6 months
Angular skeletal changes of the maxilla and mandible using cephalometric measurements
angular (°) measurement
Time frame: From date of randomization until the date of first documented acceptable correction assessed up to 6 months
Linear dental changes of the maxilla and mandible using cephalometric measurements
linear (mm) measurement
Time frame: From date of randomization until the date of first documented acceptable correction assessed up to 6 months
Angular dental changes of the maxilla and mandible using cephalometric measurements
angular (°) measurement
Time frame: From date of randomization until the date of first documented acceptable correction assessed up to 6 months
Linear soft tissue changes of the maxilla and mandible using cephalometric measurements
linear (mm) measurement
Time frame: From date of randomization until the date of first documented acceptable correction assessed up to 6 months
Angular soft tissue changes of the maxilla and mandible using cephalometric measurements
angular (°) measurement
Time frame: From date of randomization until the date of first documented acceptable correction assessed up to 6 months
Oral health quality of life questionnaire
The questionnaire (COHIP-SF-AR) will be given to the participants once informed consent is obtained at 5-time points: before treatment, 1 week, 1 month, 3 months, and 6 months after wearing functional appliances.
Time frame: From date of randomization until the date of first documented acceptable correction assessed up to 6 months
Incidence of breakages and harms reported during routine or emergency visits in both groups
Details of complications in both groups, including breakages and harms reported during routine or emergency visits, will be registered and categorized according to their nature and severity using a previously published classification system
Time frame: From date of randomization until the date of first documented acceptable correction assessed up to 6 months
Arch perimeter and depth measurement from digital model analysis
linear (mm) measurement
Time frame: From date of randomization until the date of first documented acceptable correction assessed up to 6 months
Maxillary inter-canine width from digital model analysis
linear (mm) measurement
Time frame: From date of randomization until the date of first documented acceptable correction assessed up to 6 months
Maxillary inter-first molar width from digital model analysis
linear (mm)measurement
Time frame: From date of randomization until the date of first documented acceptable correction assessed up to 6 months
Plan to share: Undecided
No publications or documents are linked to this record.
Started Apr 2025 (actual). Primary completion is estimated for Oct 2026, 17 months after the start.
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