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

January 12, 2026 updated by: Yasmin Ghaly, Mansoura University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Dakahlia Governorate
      • Al Mansurah, Dakahlia Governorate, Egypt, 35516
        • Recruiting
        • Faculty of Dentistry, Mansoura University
        • Contact:
          • Phone Number: 050 2267151

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group, who will be the untreated group.
Active Comparator: . MARA group, who will undergo MARA appliance
Device: MARA appliance
CAD/CAM 3D printed mandibular anterior repositioning appliance
Active Comparator: Fixed twin block group, who will undergo fixed twin block appliance
Device: fixed twin block
CAD/CAM 3D printed fixed twin block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
Time Frame: From date of randomization until the date of first documented acceptable correction assessed up to 6 months
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
Time Frame: From date of randomization until the date of first documented acceptable correction assessed up to 6 months
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
Time Frame: From date of randomization until the date of first documented acceptable correction assessed up to 6 months
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
Time Frame: From date of randomization until the date of first documented acceptable correction assessed up to 6 months
angular (°) measurement
From date of randomization until the date of first documented acceptable correction assessed up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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
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
linear (mm) measurement
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
linear (mm) measurement
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
linear (mm)measurement
From date of randomization until the date of first documented acceptable correction assessed up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2025

Primary Completion (Estimated)

October 15, 2026

Study Completion (Estimated)

April 27, 2027

Study Registration Dates

First Submitted

November 21, 2025

First Submitted That Met QC Criteria

January 12, 2026

First Posted (Actual)

January 14, 2026

Study Record Updates

Last Update Posted (Actual)

January 14, 2026

Last Update Submitted That Met QC Criteria

January 12, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDP.25.03.5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Class II Malocclusion

Clinical Trials on MARA appliance

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe