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

NCT07340242 | Recruiting

• 1 other identifier: MDP.25.03.5
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Class II Malocclusion; Mandibular Deficiency

Outcome Measures

Primary Outcomes (6)

• Linear Skeletal changes of the maxilla and mandible using cephalometric measurements

  linear (mm) measurement

  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

  angular (°) measurement

  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

  linear (mm) measurement

  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

  angular (°) measurement

  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

  linear (mm) measurement

  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

  angular (°) measurement

  From date of randomization until the date of first documented acceptable correction assessed up to 6 months

Secondary Outcomes (5)

• Oral health quality of life questionnaire

  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

  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

  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

  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

  From date of randomization until the date of first documented acceptable correction assessed up to 6 months

Study Arms (3)

Control group, who will be the untreated group.

NO INTERVENTION

. MARA group, who will undergo MARA appliance

ACTIVE COMPARATOR

Device: MARA appliance

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

ACTIVE COMPARATOR

Device: fixed twin block

Interventions

MARA appliance DEVICE

CAD/CAM 3D printed mandibular anterior repositioning appliance

. MARA group, who will undergo MARA appliance

fixed twin block DEVICE

CAD/CAM 3D printed fixed twin block

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

Eligibility Criteria

• Age: 9 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of dentistry, Mansoura university

Al Mansurah, Dakahlia Governorate, 35516, Egypt

RECRUITING

MeSH Terms

Conditions

Overbite; Micrognathism

Condition Hierarchy (Ancestors)

Malocclusion, Angle Class II; Malocclusion; Tooth Diseases; Stomatognathic Diseases; Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Yasmin s Ghaly, phd

CONTACT

+201065152020; yasminghaly@mans.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: January 14, 2026
• Study Start: April 27, 2025
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): April 27, 2027
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

EG (1)