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NCT Number: NCT07340242

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

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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Key information

Conditions

Class II Malocclusion Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Jaw Abnormalities Jaw Diseases Malocclusion Malocclusion, Angle Class II Mandibular Deficiency Maxillofacial Abnormalities Micrognathism Musculoskeletal Abnormalities Musculoskeletal Diseases Overbite Stomatognathic Diseases Stomatognathic System Abnormalities Tooth Diseases

Age range

9 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of dentistry, Mansoura university

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location status: Recruiting

Location contact

CONTACT

050 2267151

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MARA appliance

Device

CAD/CAM 3D printed mandibular anterior repositioning appliance

fixed twin block

Device

CAD/CAM 3D printed fixed twin block

Primary outcomes

  1. 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

    linear (mm) measurement

  2. 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

    angular (°) measurement

  3. 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

    linear (mm) measurement

  4. 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

    angular (°) measurement

  5. 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

    linear (mm) measurement

  6. 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

    angular (°) measurement

Secondary outcomes

  1. 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

    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.

  2. 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

    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

  3. 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

    linear (mm) measurement

  4. 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

    linear (mm) measurement

  5. 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

    linear (mm)measurement

Study contacts

Contact information is provided by the study sponsor or research team.

Yasmin s Ghaly, phd

CONTACT

[email protected]

+201065152020

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 14, 2026
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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