Class II Malocclusion, Mandibular Deficiency
Conditions
Brief summary
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
Interventions
DEVICEMARA appliance
CAD/CAM 3D printed mandibular anterior repositioning appliance
DEVICEfixed twin block
CAD/CAM 3D printed fixed twin block
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
9 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
1. Skeletal Class II malocclusion due to mandibular retrusion. 2. Overjet ≥ 6.0 mm. 3. Normal or low-angle growth pattern. 4. Minimum crowding in the mandibular arch. 5. Undergoing circumpubertal phase of skeletal development (CVMI 2, 3, and 4)
Exclusion criteria
1. Clinical signs and symptoms of temporomandibular disorder. 2. Systemic disease affecting bone and general growth. 3. Previous orthodontic treatment 4. Cleft lip or palate. 5. Congenital craniofacial deformity. 6. Abnormal oral habits.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Angular soft tissue changes of the maxilla and mandible using cephalometric measurements | From date of randomization until the date of first documented acceptable correction assessed up to 6 months | angular (°) measurement |
| Linear Skeletal changes of the maxilla and mandible using cephalometric measurements | From date of randomization until the date of first documented acceptable correction assessed up to 6 months | linear (mm) measurement |
| Angular skeletal changes of the maxilla and mandible using cephalometric measurements | From date of randomization until the date of first documented acceptable correction assessed up to 6 months | angular (°) measurement |
| Linear dental changes of the maxilla and mandible using cephalometric measurements | From date of randomization until the date of first documented acceptable correction assessed up to 6 months | linear (mm) measurement |
| Angular dental changes of the maxilla and mandible using cephalometric measurements | From date of randomization until the date of first documented acceptable correction assessed up to 6 months | angular (°) measurement |
| Linear soft tissue changes of the maxilla and mandible using cephalometric measurements | From date of randomization until the date of first documented acceptable correction assessed up to 6 months | linear (mm) measurement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of breakages and harms reported during routine or emergency visits in both groups | From date of randomization until the date of first documented acceptable correction assessed up to 6 months | 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 |
| Arch perimeter and depth measurement from digital model analysis | From date of randomization until the date of first documented acceptable correction assessed up to 6 months | linear (mm) measurement |
| Maxillary inter-canine width from digital model analysis | From date of randomization until the date of first documented acceptable correction assessed up to 6 months | linear (mm) measurement |
| Maxillary inter-first molar width from digital model analysis | From date of randomization until the date of first documented acceptable correction assessed up to 6 months | linear (mm)measurement |
| Oral health quality of life questionnaire | From date of randomization until the date of first documented acceptable correction assessed up to 6 months | 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. |
Countries
Egypt
Contacts
Primary ContactYasmin s Ghaly, phd
Outcome results
None listed