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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
22
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.
Faculty of dentistry, Ain Shams univeristy
Cairo, Cairo Governorate, Egypt
RECRUITINGAmount of mid-palatal suture opening.
The amount of suture separation measured in millimeters in the axial plane through CBCT X-ray
Time frame: Three weeks
Amount of dental expansion
Dental expansion will be measured as changes in inter-canine width and intermolar width (in millimeters) on digital dental models.
Time frame: Three weeks
The amount of tipping of maxillary molars and premolars.
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
Change of buccal alveolar bone thickness.
Changes in buccal alveolar bone thickness in millimeters will be measured on pre-expansion and post-expansion CBCT scans.
Time frame: Three weeks
Pain assessment
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.
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: Three weeks
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Stability of transverse skeletal width at 6 months post-expansion
The transverse skeletal dimension after appliance removal after six months post-expansion will be measured in the axial plane on the CBCT X-ray.
Time frame: Six months