3D printed reverse twin block to treat Class III malocclusion in growing kids

Is this trial a fit for you?

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

What this trial studies

This randomized controlled trial compares a novel 3D printed reverse twin block (3DRTB) with the conventional reverse twin block (CRTB) for correcting sagittal discrepancies due to maxillary deficiency in growing patients with Class III malocclusion. Participants are 8- to 13-year-olds with mixed dentition and remaining maxillary growth, assigned to either 3DRTB or CRTB for a 6-month treatment period. Outcomes include sagittal, transverse, and vertical jaw relationships, soft tissue profile, incisor inclination, patient perception via questionnaire, and oral hygiene impact. Primary focus is the effectiveness of 3DRTB in improving sagittal discrepancy; secondary aims cover morphology, aesthetics, and patient-reported experience. The study uses cephalometric criteria and clinical assessments to compare the two appliances.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. The age group selected is mixed dentition group 8-13 years with residual potential maxillary growth. Patient maturity will be assessed using the Cervical Vertebral Maturation (CVM) method on lateral cephalogram, patients in CS1-CS3 stages will be included to ensure remaining maxillary growth.
2. Presence of permanent first molar with lower anterior teeth to retain the appliance.
3. Skeletal/dental class III tendency with anterior cross bite or reverse overjet: a. Clinically the overjet is equal or less than zero up to -3 mm.

   b. Cephalometric ANB angle equal or less than zero up to -3 degrees and Wits appraisal ≤ -2.
4. Prescence of unilateral or bilateral posterior crossbite.
5. Mild to moderate anterior crowding.
6. Acceptable oral hygiene baseline defined by oral hygiene index (OHI). -

Exclusion Criteria:

1. Patients with cleft lip and palate and/or craniofacial anomalies.
2. History of previous orthopedic and/or orthodontic treatment.
3. Presence of uncontrolled systemic disease or medically compromised status.
4. Uncooperative patient/parents.

Where it's running

• Collage of Dentistry, University of Baghdad
  Baghdad, Iraq Recruiting

Study contacts

• Study coordinator: Linda Basim, PhD
• Email: landa.hadi2403@codental.uobaghdad.edu.iq
• Phone: +9647812867005

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

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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.