Clinical trial Recruiting at 1 site Interventional Ages 9 to 14

3D-printed fixed twin block versus MARA to help correct an underdeveloped lower jaw in Class II malocclusion

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

Run by Mansoura University · NCT07340242 · Data updated 2026-11-12

This research will test whether a CAD/CAM 3D-printed fixed twin block or a MARA appliance better improves dental alignment and jaw relationships in preadolescents with Class II due to a small lower jaw.

Quick facts

Study typeInterventional
Ages9 Years to 14 Years
SexAll
Enrollment60 (estimated)
SponsorMansoura University
Academic / other
Locations1 site (Al Mansurah, Dakahlia Governorate)
StatusRecruiting
StartedApril 27, 2025
Main results expectedOctober 15, 2026
Study endsApril 27, 2027
Registry record updatedJanuary 14, 2026
Trial IDNCT07340242 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are preadolescent patients in the circumpubertal growth phase (CVMI 2–4) with Class II malocclusion from mandibular retrusion, overjet ≥ 6 mm, normal or low-angle growth pattern, minimal lower‑arch crowding, and no prior orthodontic treatment.

Probably not a fit

Patients with Class II caused primarily by maxillary excess, significant mandibular crowding, prior orthodontic treatment, craniofacial anomalies, cleft conditions, systemic growth disorders, or active temporomandibular disorder are unlikely to benefit from these appliances.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, parallel-group controlled trial enrolling 60 preadolescent patients with Class II malocclusion due to mandibular retrusion, randomized 1:1:1 into three groups. Participants will receive either a CAD/CAM 3D-printed fixed twin block, a MARA appliance, or serve in a comparator group, with dentoskeletal outcomes tracked over the treatment period. Outcomes will include dental and skeletal measurements (likely cephalometric analyses) to quantify changes in jaw position and tooth relationships. Eligibility focuses on circumpubertal growth patients (CVMI 2–4) with overjet ≥ 6 mm and minimal mandibular crowding.

Why it matters

Potential benefit: If successful, the approach could improve lower-jaw growth and dental alignment in affected children, potentially reducing the need for more invasive procedures later.

How similar studies have gone: Traditional functional appliances like twin-block and MARA have shown consistent dental changes and variable modest skeletal effects, while the CAD/CAM 3D-printed fixed twin block approach is newer and less extensively studied.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Faculty of dentistry, Mansoura university
    Al Mansurah, Dakahlia Governorate, Egypt
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.