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Recruiting NCT07340242

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

No phase Interventional Class II Malocclusion Mandibular Deficiency

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MARA appliance, fixed twin block.
Who it may be relevant to
Registry conditions: Class II Malocclusion, Mandibular Deficiency. Basic parameters: 9 years — 14 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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: A Randomized Controlled Trial

Overview

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

  • Device MARA appliance
    CAD/CAM 3D printed mandibular anterior repositioning appliance
  • Device fixed twin block
    CAD/CAM 3D printed fixed twin block

Primary outcome measures

  • Linear Skeletal changes of the maxilla and mandible using cephalometric measurements [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 [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 [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 [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 [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 [Time frame: From date of randomization until the date of first documented acceptable correction assessed up to 6 months]
Secondary outcome measures (5)
  • Oral health quality of life questionnaire [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 [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 [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 [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 [Time frame: From date of randomization until the date of first documented acceptable correction assessed up to 6 months]

Eligibility criteria

Inclusion criteria

  • Skeletal Class II malocclusion due to mandibular retrusion.
  • Overjet ≥ 6.0 mm.
  • Normal or low-angle growth pattern.
  • Minimum crowding in the mandibular arch.
  • Undergoing circumpubertal phase of skeletal development (CVMI 2, 3, and 4)

Exclusion criteria

  • Clinical signs and symptoms of temporomandibular disorder.
  • Systemic disease affecting bone and general growth.
  • Previous orthodontic treatment
  • Cleft lip or palate.
  • Congenital craniofacial deformity.
  • Abnormal oral habits.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of dentistry, Mansoura university — Al Mansurah

Identifiers

NCT: NCT07340242 · MDP.25.03.5

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗