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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group, who will be the untreated group. | No Intervention | ||
| . MARA group, who will undergo MARA appliance | Active Comparator |
| |
| Fixed twin block group, who will undergo fixed twin block appliance | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MARA appliance | Device | CAD/CAM 3D printed mandibular anterior repositioning appliance |
|
| Measure | Description | Time Frame |
|---|---|---|
| Linear Skeletal changes of the maxilla and mandible using cephalometric measurements | linear (mm) measurement | 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 | 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 | 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 | 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 | 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 | From date of randomization until the date of first documented acceptable correction assessed up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From date of randomization until the date of first documented acceptable correction assessed up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yasmin s Ghaly, phd | Contact | +201065152020 | yasminghaly@mans.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of dentistry, Mansoura university | Recruiting | Al Mansurah | Dakahlia Governorate | 35516 | Egypt |
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| ID | Term |
|---|---|
| D057887 | Overbite |
| D008844 | Micrognathism |
| ID | Term |
|---|---|
| D008312 | Malocclusion, Angle Class II |
| D008310 | Malocclusion |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| fixed twin block | Device | CAD/CAM 3D printed fixed twin block |
|
| 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 | 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 | 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 | 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 | From date of randomization until the date of first documented acceptable correction assessed up to 6 months |
| D007569 |
| Jaw Abnormalities |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D019767 | Maxillofacial Abnormalities |
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D018640 | Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |