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

NCT ID: NCT07340242

Last Updated: 2026-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-27

Study Completion Date

2027-04-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Class II Malocclusion Mandibular Deficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group, who will be the untreated group.

Group Type NO_INTERVENTION

No interventions assigned to this group

. MARA group, who will undergo MARA appliance

Group Type ACTIVE_COMPARATOR

MARA appliance

Intervention Type DEVICE

CAD/CAM 3D printed mandibular anterior repositioning appliance

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

Group Type ACTIVE_COMPARATOR

fixed twin block

Intervention Type DEVICE

CAD/CAM 3D printed fixed twin block

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

fixed twin block

CAD/CAM 3D printed fixed twin block

Intervention Type DEVICE

MARA appliance

CAD/CAM 3D printed mandibular anterior repositioning appliance

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

9 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mansoura University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yasmin Ghaly

Assistant Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of dentistry, Mansoura university

Al Mansurah, Dakahlia Governorate, Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yasmin s Ghaly, phd

Role: CONTACT

+201065152020

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Role: primary

050 2267151

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MDP.25.03.5

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.