3D-printed miniscrew-supported device to move upper molars backward

Evaluation of Three-Dimensional Printed Orthodontic Molar Distalizer (Randomized Clinical Trial)

This tests a new 3D-printed miniscrew-supported device against a conventional miniscrew distal-jet to move upper molars back in people with bilateral Class II molar relationships and upper-arch crowding.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 28 (estimated)
• Ages: 16 Years to 30 Years
• Sex: All
• Sponsor: University of Baghdad (other)
• Locations: 1 site (Baghdad, Al-Russafa)
• Trial ID: NCT07191158 on ClinicalTrials.gov

What this trial studies

This is a randomized, two-arm trial comparing a conventional miniscrew-supported distal-jet appliance to a newly designed 3D-printed miniscrew-supported molar distalizer for correction of bilateral Class II molar relationships and upper-arch crowding. Patients will be randomly assigned to one of the two devices and treated until the planned molar distalization is achieved. Lateral cephalometric radiographs and digital upper-arch models will be taken before treatment (T0) and after distalization (T1) to quantify tooth movement and anchorage effects. Device performance, measured tooth movement, and clinical outcomes will be compared between groups to see if the 3D-printed appliance provides equivalent or improved results.

Who should consider this trial

Good fit: Patients with bilateral Class II molar relationships, fully erupted upper second molars, upper-arch crowding, good oral health, and no prior orthopedic or orthodontic treatment are ideal candidates.

Not a fit: Patients with cleft lip/palate or craniofacial syndromes, active periodontal disease, severe maxillary molar rotation, bad oral habits, or prior orthodontic treatment are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, the 3D-printed device could provide a more customized fit and potentially faster or more controlled molar distalization with similar or improved comfort.

How similar studies have performed: Miniscrew-supported distalization devices have established clinical evidence, while 3D-printed customized distalizers are a newer approach with limited but emerging clinical data.

Eligibility criteria

Inclusion Criteria:

1. Class II molar relationships bilaterally, with fully erupted 2nd molar.
2. No or minor crowding on the mandible to \[reserve Class I posterior occlusion after treatment.
3. Good oral health free from caries and periodontal problems at the start of treatment.

   \-

Exclusion Criteria:

1. Previous history of orthopedic and/or orthodontic treatment.
2. Patients with cleft lip and palate and/or craniofacial syndrome
3. Patients with bad oral habit.
4. Active periodontal disease.
5. Sever rotation of maxillary molars. -

Where this trial is running

Baghdad, Al-Russafa

• College of Dentistry-University of Baghdad — Baghdad, Al-Russafa, Iraq (RECRUITING)

Study contacts

• Study coordinator: Mushriq Abid Fawzi Professor, PhD

Conditions: Tooth Movement Techniques, Distalization by Miniscrews, Distalization, tooth movement, 3D printing