Actively Recruiting
Evaluating the Clinical Performance of a Novel Clear Orthodontic Expander Versus Hyrax: A Randomized Clinical Trial
Led by University of Baghdad · Updated on 2026-04-22
40
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new clear orthodontic expander made from a 2-mm biocompatible polyethylene terephthalate glycol (PETG) material with an expansion screw to see how well it achieves dental and skeletal expansion in adolescents. This is compared to a conventional Hyrax expander in a randomized clinical trial involving patients aged 10 to 14 years with malocclusion and narrow maxilla. The study will be conducted at multiple dental centers including the University of Baghdad and affiliated clinics. Participants will be randomly assigned to one of two groups: one using the new clear expander and the other using the Hyrax expander. The clear expander is custom-made using a 3D-printed maxillary dental cast, incorporating a standard or universal expansion screw. Both expanders will be activated twice daily with 0.2 mm turns until the desired maxillary arch expansion is reached. Patients using the clear expander will wear it 24 hours daily except during eating and cleaning. During the study, participants will undergo CBCT scans and intraoral scans before and immediately after treatment, approximately one to two months apart. Clinical and cephalometric evaluations will also be performed, along with microbial assessments after one month. Patients will complete questionnaires about their treatment experience and satisfaction. Data will be analyzed statistically to compare the effectiveness and clinical performance of the two devices.
CONDITIONS
Brief Title
Clear Orthodontic Expander Versus Hyrax
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 10 to 14 years at the start of treatment
- Unstable unilateral or bilateral posterior crossbite due to maxillary constriction
- Fully erupted first molars
- Good oral health free from cavities and periodontal problems at treatment start
- Good general health
You will not qualify if you...
- Presence of obvious facial asymmetry
- History of orofacial cleft
- Previous orthodontic treatment
- Presence of bad oral habits
- Active periodontal disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 to 2 months
Participants receive either a new clear orthodontic expander or a Hyrax expander. They will activate the expander twice daily until the desired maxillary arch expansion is achieved.
Regular visits for appliance activation and monitoring
Duration - Up to 1 month after treatment
Participants undergo post-treatment evaluations including CBCT, intraoral scans, clinical and cephalometric analysis, microbial evaluation, and complete a satisfaction questionnaire.
1 to 2 visits depending on assessment needs
Trial Site Locations
Total: 1 location
1
University of Baghdad/Collage of Dentistry
Baghdad, Al-Rusafa, Bab Al-moadham, Iraq
Actively Recruiting
Research Team
N
Noor FK Al-Khawaja, BDS, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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