Dentoskeletal Effects of 3D-Printed Fixed Twin Block Versus MARA Appliances in Management of Skeletal Class II

Mansoura University

Status: Enrolling

Conditions: Mandibular Deficiency; Class II Malocclusion

Treatments: Device: fixed twin block; Device: MARA appliance

Study type: Interventional

Funder types: Other

Identifiers

NCT07340242

MDP.25.03.5

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 9 to 14 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

Control group, who will be the untreated group.

No Intervention group

. MARA group, who will undergo MARA appliance

Active Comparator group

Treatment:

Device: MARA appliance

Fixed twin block group, who will undergo fixed twin block appliance

Active Comparator group

Treatment:

Device: fixed twin block