3D-printed bone-borne maxillary expander for young adults
The The Effect of 3D Printed Framework Bone-Borne Rapid Maxillary Expander in Young Adults: a CBCT Study
This trial will test a 3D‑printed, bone‑anchored palatal expander to see if it can widen the midpalatal suture and correct a narrow upper jaw in adults aged 18 to 30.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years to 30 Years |
| Sex | All |
| Sponsor | Mansoura University Academic / other |
| Locations | 1 site (Al Mansurah) |
| Trial ID | NCT07331207 on ClinicalTrials.gov |
What this trial studies
Researchers will use intraoral scans and CBCT images to design a custom 3D‑printed framework that attaches to four miniscrews placed in the palate. After local anesthesia, four OrthoEasy Pal miniscrews (about 10 mm long, 1.7–1.8 mm diameter) will be placed and the device secured to them, with patients turning the screw once per day (0.25 mm per turn). CBCT will be taken before treatment and again three months after the first activation to measure midpalatal suture width, tooth inclination, and buccal bone thickness using defined anatomic landmarks. The planned sample size is 16 adults aged 18–30 based on a prior effect-size estimate.
Who should consider this trial
Good fit: Ideal candidates are adults 18–30 with transverse maxillary deficiency who have intact first and second upper premolars and first upper molars, good periodontal health, and no prior orthodontic treatment.
Not a fit: Patients under 18, those missing required upper teeth, those with poor oral hygiene or periodontal disease, significant dentofacial anomalies or systemic illness, or pregnant individuals are unlikely to benefit or are ineligible.
Why it matters
Potential benefit: If effective, this approach could provide predictable skeletal expansion in young adults while reducing dental tipping and preserving buccal bone.
How similar studies have performed: Miniscrew-assisted and bone‑borne palatal expanders have shown promising results in skeletally mature patients, though fully 3D‑printed, purely bone‑borne framework designs are less extensively studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Transverse maxillary deficiency with or without crossbite; who requires maxillary expansion * Age: (18 to 30) years. * presence of first and second upper premolars and first upper molars * No previous orthodontic treatment. * Good oral hygiene and healthy periodontal tissue. * No significant dentofacial anomalies, any bone defects, or systemic disease. * Not being pregnant. Exclusion Criteria: * previous orthodontic treatment. * significant dentofacial anomalies, any bone defects, or systemic disease. * pregnant. * bad oral hygiene and healthy periodontal tissue. * loss first and second upper premolars and first upper molars * growing patients
Where this trial is running
Al Mansurah
- faculty of dentistry- Mansoura University — Al Mansurah, Egypt (Recruiting)
Study contacts
- Study coordinator: Mohammad Radwan Alrefai, dentist
- Email: mhmd1alrifai@gmail.com
- Phone: 01029054360
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.