Dentoskeletal Effects of 3D-Printed Fixed Twin Block Versus MARA Appliances in Management of Skeletal Class II
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age9-14
SponsorMansoura University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Skeletal Class II malocclusion due to mandibular retrusion.
Overjet ≥ 6.0 mm.
Normal or low-angle growth pattern.
Minimum crowding in the mandibular arch.
Disqualifiers
Clinical signs and symptoms of temporomandibular disorder.
Systemic disease affecting bone and general growth.
Previous orthodontic treatment
Cleft lip or palate.
Trial design
Design model
Parallel
Treatments tested in this trial
MARA appliance
DeviceCAD/CAM 3D printed mandibular anterior repositioning appliance
fixed twin block
DeviceCAD/CAM 3D printed fixed twin block
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Control group, who will be the untreated group.No intervention 0 interventions
Group B: . MARA group, who will undergo MARA applianceActive comparator 1 intervention
Group C: Fixed twin block group, who will undergo fixed twin block applianceActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 months2
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 months3
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 months4
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 monthsSecondary outcomes
1
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 months2
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 months3
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 months4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov