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 type | Interventional |
|---|---|
| Ages | 9 Years to 14 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Mansoura University Academic / other |
| Locations | 1 site (Al Mansurah, Dakahlia Governorate) |
| Status | Recruiting |
| Started | April 27, 2025 |
| Main results expected | October 15, 2026 |
| Study ends | April 27, 2027 |
| Registry record updated | January 14, 2026 |
| Trial ID | NCT07340242 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
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Faculty of dentistry, Mansoura university
Al Mansurah, Dakahlia Governorate, Egypt Recruiting
Study contacts
- Study coordinator: Yasmin s Ghaly, phd
- Email: yasminghaly@mans.edu.eg
- Phone: +201065152020
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.