Clear thermoplastic maxillary expander versus Hyrax for adolescents
Evaluating the Clinical Performance of a Novel Clear Orthodontic Expander Versus Hyrax: A Randomized Clinical Trial
This will test whether a clear PETG thermoplastic expander with an integrated screw works as well as a Hyrax expander to widen the upper jaw in adolescents (ages 10–14) with a narrow maxilla.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 10 Years to 14 Years |
| Sex | All |
| Sponsor | University of Baghdad Academic / other |
| Locations | 1 site (Baghdad, Al-Rusafa, Bab Al-moadham) |
| Trial ID | NCT07362160 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, randomized, two-arm parallel trial comparing a 2-mm PETG clear expander with an integrated expansion screw to the conventional Hyrax expander in adolescents. About 20 patients per group (allowing for dropouts) will be enrolled at the University of Baghdad College of Dentistry and affiliated centers, with randomization for both expander type and for one of two cleaning methods for the clear device. Outcomes include CBCT measures of skeletal and dental expansion, intraoral scans, cephalometric angles, microbial counts related to cleaning method, and patient experience/satisfaction questionnaires. Clinically effective expansion is defined as 2.5 mm or greater of maxillary sutural opening.
Who should consider this trial
Good fit: Ideal candidates are healthy adolescents aged 10–14 with a posterior crossbite from maxillary constriction, fully erupted first molars, and good oral and general health.
Not a fit: Patients with obvious facial asymmetry, orofacial clefts, prior orthodontic treatment, bad oral habits, active periodontal disease, or outside the 10–14 age range are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the clear PETG expander could provide equivalent maxillary expansion while offering better esthetics and possibly greater comfort and hygiene options for adolescent patients.
How similar studies have performed: Related clear or removable expander approaches have shown some success in dental expansion, but this specific PETG thermoplastic design with an integrated screw is relatively new and evidence is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients' age at the start of treatment will range from 10-14 years. 2. Unstable unilateral or bilateral posterior crossbite due to maxillary constriction. 3. The first molars are fully erupted. 4. Good oral health free from caries and periodontal problems at the start of treatment. 5. Good general health. Exclusion Criteria: 1. Patients with obvious facial asymmetry. 2. Patients with orofacial cleft. 3. Patients with previous orthodontic treatment. 4. Patients with bad oral habits. 5. Patients with active periodontal disease.
Where this trial is running
Baghdad, Al-Rusafa, Bab Al-moadham
- University of Baghdad/Collage of Dentistry — Baghdad, Al-Rusafa, Bab Al-moadham, Iraq (Recruiting)
Study contacts
- Study coordinator: Noor FK Al-Khawaja, BDS, MSc
- Email: noor.alkhawaja@codental.uobaghdad.edu.iq
- Phone: +9647712222834
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.