Transverse Maxillary DeficiencyNCT07338591
Digital vs. Analog Inputs in CAD/CAM Orthodontics: A Comparative Clinical Evaluation of Palatal Expander Fabrication Workflow
An observational study of Transverse Maxillary Deficiency, run by Mansoura University at 2 sites in Egypt.
Trial summary
36 patients with unilateral or bilateral cross bite treated with hyrax expanders fabricated through three distinct workflows: fully conventional (physical impression + manual fabrication), hybrid (physical impression + CAD/CAM fabrication), and fully digital (intraoral scanning + CAD/CAM fabrication). Read more about this study
- Who is it for?
- Ages 8 to 13 months
- Conditions the study is for
- Transverse Maxillary Deficiency
- How many people
- 36 participants
- Where
- 2 sitesEgypt
- Study dates
- 25 Dec 2025to 25 Jul 2027
- Phase
- Observational
- 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 8 to 13 months
- All sexes
- No healthy volunteers
- Child
Study population: A total of 36 participants will be selected from outpatient clinic of orthodontics department (Faculty of Dentistry - Mansoura University). Written consent will be obtained from all legal guardians prior to enrollment.
Who may be able to join
- • Aged between 8 and 13 years with transverse maxillary deficiency ( with unilateral or bilateral crossbite ,with or without anterior cross bite)
- Indicated for tooth-borne maxillary expansion
- Good oral hygiene and cooperative behavior
- No prior orthodontic treatment
Who cannot join
- • Craniofacial anomalies or syndromes
- Requirement for surgically assisted expansion
- Poor oral hygiene or high caries index
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites
faculty of dentistry , Mansoura university
Al Mansurah, 35516
samar essam saleh, masters of orthodontics, 00201093916939, samaressam700@gmail.com
noheir samir elshall, PhD of orthodontics, 01222523151, samaressam700@gmail.com
faculty of dentistry , Mansoura university
Al Mansurah
About this study
36 patients with unilateral or bilateral cross bite treated with hyrax expanders fabricated through three distinct workflows: fully conventional (physical impression + manual fabrication), hybrid (physical impression + CAD/CAM fabrication), and fully digital (intraoral scanning + CAD/CAM fabrication). To evaluate and compare the clinical fit, workflow efficiency, and patient/clinician satisfaction of palatal expanders fabricated using traditional, hybrid digital, and fully digital workflows.
Read the detailed description
This randomized, three-arm clinical trial aims to compare the clinical performance and workflow efficiency of tooth-borne palatal expanders fabricated using three different manufacturing workflows: fully conventional, hybrid digital, and fully digital. The study evaluates the impact of these workflows on appliance fit at delivery, efficiency of clinical and laboratory procedures, and patient- and clinician-reported satisfaction.
Following enrollment, participants will be randomly allocated into one of three equal groups using a computer-generated randomization sequence. All appliances used in the study will be Hyrax-type maxillary expanders designed to deliver comparable transverse expansion forces, with differences limited to the fabrication workflow.
In the fully conventional workflow, maxillary impressions will be obtained using conventional impression materials. Dental stone casts will be poured and used directly for appliance fabrication. The Hyrax expander will be manually fabricated on the physical cast using traditional laboratory techniques, including wire bending, band adaptation, and soldering or brazing of the expansion screw and components.
In the hybrid digital workflow, maxillary impressions will also be taken using conventional impression materials and poured in dental stone. The resulting physical casts will then be digitized using a desktop optical scanner. The scanned models will be imported into computer-aided design (CAD) software, where the palatal expander will be digitally designed. Appliance fabrication will be completed using additive manufacturing (3D printing), followed by incorporation of the expansion screw as required.
In the fully digital workflow, maxillary arches will be captured directly using an intraoral optical scanner. The generated virtual models will be used without producing a physical cast. Appliance design will be performed entirely within CAD software, and the Hyrax-type expander will be fabricated using 3D printing technology.
At appliance delivery, clinical evaluation will be performed to assess accuracy of fit, seating on the teeth, need for adjustment, and overall clinical acceptability. Any required chairside modifications will be recorded. Workflow efficiency will be assessed by documenting clinical chairside time, laboratory production time, and the incidence of remakes or significant adjustments.
Patient comfort and acceptance, as well as clinician satisfaction with appliance fit and handling, will be assessed using structured questionnaires. Data collected from all three groups will be compared to determine differences in clinical performance and workflow efficiency among conventional, hybrid, and fully digital fabrication approaches.
- Conditions
- Transverse Maxillary Deficiency
- Keywords
- Palatal Expander, Hyrax Expander, CAD/CAM Orthodontics, Digital Workflow, Intraoral Scanning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Fully Analogue Workflow | * Input: Physical impression. * Model: Poured in dental stone to produce physical model. * Fabrication: Hyrax expander fabricated manually by soldering/brazing components directly on the plaster cast using traditional laboratory techniques. | |
| Hybrid Workflow | * Input: Physical impression * Model: Poured in dental stone to produce physical model. * Digitization: Desktop scanning of physical model * Fabrication: CAD-designed and 3D-printed appliance (Hyrax-type), | |
| Fully Digital Workflow | * Input: Intraoral scan (IOS) using an optical scanner * Model: Virtual model used directly in design software. * Fabrication: CAD-designed and 3D-printed appliance (Hyrax-type), |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Fit and accuracy of expander
For the clinical fit of the palatal expander at delivery, a 5-point Likert scale could be used by the clinician as follows:
Score Description
- Very poor fit - Significant rocking or instability; requires remake
- Poor fit - Major adjustment required (e.g., soldering, bending)
- Acceptable fit - Minor chairside adjustments needed
- Good fit - Minimal adjustment required
- Excellent fit - No adjustment needed, passive and accurate seating
Measured: Immediately after appliance insertion
Secondary outcomes (1)
Workflow and Chairside adjustment time
Time measured in minutes from impression to appliance delivery
Measured: Immediately after appliance insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start25 Dec 2025 (estimated)
- Primary completion25 Jan 2027 (estimated)
- Study completion25 Jul 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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07338591
- Sponsor's protocol ID
- MD.25.06.22
- Status last verified
- Jul 2025
- First submitted
- 18 Dec 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: data with request
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital vs. Analog Inputs in CAD/CAM Orthodontics: A Comparative Clinical Evaluation of Palatal Expander Fabrication Workflow
- ClinicalTrials.gov ID
- NCT07338591
- Acronym / sponsor ID
- MD.25.06.22
- Conditions
- Transverse Maxillary Deficiency
- Keywords
- Palatal Expander, Hyrax Expander, CAD/CAM Orthodontics, Digital Workflow, Intraoral Scanning
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 25 Dec 2025 (estimated)
- Primary completion
- 25 Jan 2027 (estimated)
- Study completion
- 25 Jul 2027 (estimated)
- First posted
- 14 Jan 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.
36 patients with unilateral or bilateral cross bite treated with hyrax expanders fabricated through three distinct workflows: fully conventional (physical impression + manual fabrication), hybrid (physical impression + CAD/CAM fabrication), and fully digital (intraoral scanning + CAD/CAM fabrication). To evaluate and compare the clinical fit, workflow efficiency, and patient/clinician satisfaction of palatal expanders fabricated using traditional, hybrid digital, and fully digital workflows.
Detailed description
This randomized, three-arm clinical trial aims to compare the clinical performance and workflow efficiency of tooth-borne palatal expanders fabricated using three different manufacturing workflows: fully conventional, hybrid digital, and fully digital. The study evaluates the impact of these workflows on appliance fit at delivery, efficiency of clinical and laboratory procedures, and patient- and clinician-reported satisfaction.
Following enrollment, participants will be randomly allocated into one of three equal groups using a computer-generated randomization sequence. All appliances used in the study will be Hyrax-type maxillary expanders designed to deliver comparable transverse expansion forces, with differences limited to the fabrication workflow.
In the fully conventional workflow, maxillary impressions will be obtained using conventional impression materials. Dental stone casts will be poured and used directly for appliance fabrication. The Hyrax expander will be manually fabricated on the physical cast using traditional laboratory techniques, including wire bending, band adaptation, and soldering or brazing of the expansion screw and components.
In the hybrid digital workflow, maxillary impressions will also be taken using conventional impression materials and poured in dental stone. The resulting physical casts will then be digitized using a desktop optical scanner. The scanned models will be imported into computer-aided design (CAD) software, where the palatal expander will be digitally designed. Appliance fabrication will be completed using additive manufacturing (3D printing), followed by incorporation of the expansion screw as required.
In the fully digital workflow, maxillary arches will be captured directly using an intraoral optical scanner. The generated virtual models will be used without producing a physical cast. Appliance design will be performed entirely within CAD software, and the Hyrax-type expander will be fabricated using 3D printing technology.
At appliance delivery, clinical evaluation will be performed to assess accuracy of fit, seating on the teeth, need for adjustment, and overall clinical acceptability. Any required chairside modifications will be recorded. Workflow efficiency will be assessed by documenting clinical chairside time, laboratory production time, and the incidence of remakes or significant adjustments.
Patient comfort and acceptance, as well as clinician satisfaction with appliance fit and handling, will be assessed using structured questionnaires. Data collected from all three groups will be compared to determine differences in clinical performance and workflow efficiency among conventional, hybrid, and fully digital fabrication approaches.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fully Analogue Workflow | – | –* Input: Physical impression. * Model: Poured in dental stone to produce physical model. * Fabrication: Hyrax expander fabricated manually by soldering/brazing components directly on the plaster cast using traditional laboratory techniques. |
| Hybrid Workflow | – | –* Input: Physical impression * Model: Poured in dental stone to produce physical model. * Digitization: Desktop scanning of physical model * Fabrication: CAD-designed and 3D-printed appliance (Hyrax-type), |
| Fully Digital Workflow | – | –* Input: Intraoral scan (IOS) using an optical scanner * Model: Virtual model used directly in design software. * Fabrication: CAD-designed and 3D-printed appliance (Hyrax-type), |
Who may qualify
- Ages
- 8 to 13 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- A total of 36 participants will be selected from outpatient clinic of orthodontics department (Faculty of Dentistry - Mansoura University). Written consent will be obtained from all legal guardians prior to enrollment.
Key inclusion criteria (4 listed)
- • Aged between 8 and 13 years with transverse maxillary deficiency ( with unilateral or bilateral crossbite ,with or without anterior cross bite)
Key exclusion criteria (3 listed)
- • Craniofacial anomalies or syndromes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical Fit and accuracy of expander
Time frame: Immediately after appliance insertion
For the clinical fit of the palatal expander at delivery, a 5-point Likert scale could be used by the clinician as follows: Score Description 1. Very poor fit - Significant rocking or instability; requires remake 2. Poor fit - Major adjustment required (e.g., soldering, bending) 3. Acceptable fit - Minor chairside adjustments needed 4. Good fit - Minimal adjustment required 5. Excellent fit - No adjustment needed, passive and accurate seating
1 secondary outcome
Workflow and Chairside adjustment time
Time frame: Immediately after appliance insertion
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 14 Jan 2026.
- Individual participant dataSharing planned: Yes. data with request
Related trials for Transverse Maxillary Deficiency
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Evaluation of Occlusal Force Following Rapid Maxillary Expansion Assisted by Piezocision in Different Age Groups
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Posterior Resin Bite Turbos Effect on Maxillary Expansion Using a HYRAX Expander in Early Adolescents
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transverse Maxillary Deficiency, run by Mansoura University at 2 sites 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 3 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: opening soon, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 samar essam saleh, master of orthodontics (00201093916939, samaressam700@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Fit and accuracy of expander (time frame: Immediately after appliance insertion). 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 14 Jan 2026.