Transverse Maxillary DeficiencyNCT07411092
Three-dimensionally Printed Hyrax Versus Conventional Hyrax for Maxillary Arch Expansion in Adolescents
A study testing Three dimensionally printed hyrax expander and Conventionally Fabricated Hyrax Expander in people with Transverse Maxillary Deficiency and Maxillary Expansion, run by Ain Shams University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Transverse Maxillary Deficiency, Maxillary Expansion
- What is being tested?
- Three dimensionally printed hyrax expander and Conventionally Fabricated Hyrax Expander
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2025to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients aged between 12 to 17 years.
- Skeletal age ranges from CVMS 3 to CVMS 5.
- Skeletal maxillary transverse deficiency with/without crossbite.
- Cooperative and able to attend follow-up visits.
Who cannot join
- Previous orthodontic treatment.
- Craniofacial syndromes, or cleft lip and/or palate.
- Patients with vertical growth pattern.
- Very bad oral hygiene and active periodontal disease.
- Vulnerable groups such as individuals with cognitive impairments or intellectual disabilities and individuals with severe mental health disorders.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of dentistry, Ain Shams univeristy
Cairo, Cairo Governorate, 11566
Sara Sherif Saleh Sherif Assistant lecturer, A, +20 1061531431, sarasaleh@dent.asu.edu.eg
About this study
Official title: Three-dimensionally Printed Hyrax Versus Conventional Hyrax for Maxillary Arch Expansion in Adolescents: A Randomized Controlled Trial
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.
Read the detailed description
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.
- Being tested
- Three dimensionally printed hyrax expander, Conventionally Fabricated Hyrax Expander
- Keywords
- Maxillary Expansion, Hyrax expander
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three dimensionally printed hyrax expanderDevice
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.
Conventionally Fabricated Hyrax ExpanderDevice
Group B: A conventionally fabricated Hyrax expander used for rapid maxillary expansion . The device is made using traditional laboratory techniques.
| Study group | Role | What they receive |
|---|---|---|
| Group A: 3D-Printed Hyrax Expander | Experimental | Adolescent patients diagnosed with transverse maxillary arch constriction will undergo maxillary expansion using a three-dimensionally printed Hyrax expander. Receives: Device: Three dimensionally printed hyrax expander |
| Group B: Conventionally Fabricated Hyrax Expander | Active comparator | Adolescent patients diagnosed with transverse maxillary arch constriction will undergo maxillary expansion using using a conventionally fabricated Hyrax expander. Receives: Device: Conventionally Fabricated Hyrax Expander |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of mid-palatal suture opening.
The amount of suture separation measured in millimeters in the axial plane through CBCT X-ray
Measured: Three weeks
Secondary outcomes (6)
Amount of dental expansion
Dental expansion will be measured as changes in inter-canine width and intermolar width (in millimeters) on digital dental models.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Three weeks
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.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start1 Aug 2025
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transverse Maxillary DeficiencyStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07411092
- Sponsor's protocol ID
- FDASU-Rec IR/D072507
- Status last verified
- Feb 2026
- First submitted
- 24 Jan 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-dimensionally Printed Hyrax Versus Conventional Hyrax for Maxillary Arch Expansion in Adolescents: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07411092
- Acronym / sponsor ID
- FDASU-Rec IR/D072507
- Keywords
- Maxillary Expansion, Hyrax expander
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: 3D-Printed Hyrax Expander | Experimental | Device: Three dimensionally printed hyrax expanderAdolescent patients diagnosed with transverse maxillary arch constriction will undergo maxillary expansion using a three-dimensionally printed Hyrax expander. |
| Group B: Conventionally Fabricated Hyrax Expander | Active comparator | Device: Conventionally Fabricated Hyrax ExpanderAdolescent patients diagnosed with transverse maxillary arch constriction will undergo maxillary expansion using using a conventionally fabricated Hyrax expander. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients aged between 12 to 17 years.
- Skeletal age ranges from CVMS 3 to CVMS 5.
- Skeletal maxillary transverse deficiency with/without crossbite.
- Cooperative and able to attend follow-up visits.
Key exclusion criteria (5 listed)
- Previous orthodontic treatment.
- Craniofacial syndromes, or cleft lip and/or palate.
- Patients with vertical growth pattern.
- Very bad oral hygiene and active periodontal disease.
- Vulnerable groups such as individuals with cognitive impairments or intellectual disabilities and individuals with severe mental health disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Three dimensionally printed hyrax expanderGroup 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. | Device | Group A: 3D-Printed Hyrax Expander |
| Conventionally Fabricated Hyrax ExpanderGroup B: A conventionally fabricated Hyrax expander used for rapid maxillary expansion . The device is made using traditional laboratory techniques. | Device | Group B: Conventionally Fabricated Hyrax Expander |
Primary outcome
Amount of mid-palatal suture opening.
Time frame: Three weeks
The amount of suture separation measured in millimeters in the axial plane through CBCT X-ray
6 secondary outcomes
Amount of dental expansion
Time frame: Three weeks
The amount of tipping of maxillary molars and premolars.
Time frame: Three weeks
Change of buccal alveolar bone thickness.
Time frame: Three weeks
Pain assessment
Time frame: Three weeks
Oral health-related quality of life.
Time frame: Three weeks
Stability of transverse skeletal width at 6 months post-expansion
Time frame: Six months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Three dimensionally printed hyrax expander and Conventionally Fabricated Hyrax Expander in people with Transverse Maxillary Deficiency and Maxillary Expansion, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara S Mandour, Msc, Assistant lecturer (+201061531431, sarasaleh@dent.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of mid-palatal suture opening. (time frame: Three weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.