Faculty of dentistry, Ain Shams univeristy
Cairo, Cairo Governorate, 11566, Egypt
Location status: Recruiting
NCT Number: NCT07411092
This clinical trial aims to compare the skeletal and dental effects of conventional Hyrax expanders and 3D-printed Hyrax expanders in adolescent patients with maxillary transverse deficiency. Using cone-beam computed tomography (CBCT) and digital models, the study evaluates the precision, customization, and treatment outcomes of both appliance types to inform evidence-based orthodontic treatment planning.
Interested in participating?
Request Info12 year–17 year
All sexes
Interventional
Not applicable
Cairo, Cairo Governorate, 11566, Egypt
Location status: Recruiting
Maxillary transverse deficiency is a common orthodontic problem that often requires skeletal expansion using appliances such as the Hyrax expander. While conventional Hyrax expanders have been widely used, advancements in digital dentistry have introduced 3D-printed alternatives that offer potential benefits in precision, customization, and patient comfort. However, there is currently no clinical evidence comparing the skeletal and dental effects of these two designs.
This study addresses this gap by evaluating and comparing the outcomes of conventional and 3D-printed Hyrax expanders in adolescent patients, a critical developmental stage where maxillary expansion becomes more challenging due to progressive maturation and increased resistance of the mid-palatal suture. The study uses cone-beam computed tomography (CBCT) and digital models to assess skeletal and dental changes, providing clinically relevant data to guide orthodontic treatment planning and appliance selection.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Group A : A 3D-printed Hyrax expander designed for rapid maxillary expansion in orthodontic treatment. The device is manufactured using additive manufacturing technology for a customized fit.
Group B: A conventionally fabricated Hyrax expander used for rapid maxillary expansion . The device is made using traditional laboratory techniques.
Time frame: Three weeks
The amount of suture separation measured in millimeters in the axial plane through CBCT X-ray
Time frame: Three weeks
Dental expansion will be measured as changes in inter-canine width and intermolar width (in millimeters) on digital dental models.
Time frame: Three weeks
Buccolingual tipping of maxillary molars and premolars will be quantified as angular changes measured on CBCT by comparing pre-expansion and post-expansion images.
Time frame: Three weeks
Changes in buccal alveolar bone thickness in millimeters will be measured on pre-expansion and post-expansion CBCT scans.
Time frame: Three weeks
Evaluating the pain experienced during the active expansion phase using the Visual Analogue Scale (VAS; 0-100 mm), where 0 mm represents no pain and 100 mm represents the worst imaginable pain; the higher the value in the VAS scale, the more severe the pain.
Time frame: Three weeks
Oral health-related quality of life was assessed using the Oral Health Impact Profile-14 (OHIP-14). Items are rated on a 5-point Likert scale (0 = never to 4 = very often). Results are presented as mean scores (0-4); higher values indicate worse oral health-related quality of life.
Time frame: Six months
The transverse skeletal dimension after appliance removal after six months post-expansion will be measured in the axial plane on the CBCT X-ray.
Contact information is provided by the study sponsor or research team.
Marwah S Abdel-Latif, Msc, PHD, Lecturer
CONTACT
Sara S Mandour, Msc, Assistant lecturer
CONTACT
Ain Shams University
Other
Three-dimensionally Printed Hyrax Versus Conventional Hyrax for Maxillary Arch Expansion in Adolescents: A Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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