Maxillary ExpansionNCT07036822
Effects of Skeletal Anchored Maxillary Expander for Constricted Maxilla
A study testing Skeletal Anchored Maxillary Expander (MARPE) in people with Maxillary Expansion, run by Samar Hassan Mahmoud Mohamed.
Trial summary
The aim of study will be Evaluation of Effects of skeletal anchored maxillary expander for constricted maxilla with different patient's age Read more about this study
- Who is it for?
- Ages 12 to 25 years
- Conditions the study is for
- Maxillary Expansion
- What is being tested?
- Skeletal Anchored Maxillary Expander (MARPE)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Dec 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 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Skeletal maxillary transverse deficiency.
- Unilateral or bilateral posterior crossbite. .Patient maintains good oral hygiene and overall health.
- Patient with no previous orthodontic treatment.
- No systemic disease that may affect bone quality or interfere with orthodontic treatment.
- Adolescent and adult patien
Who cannot join
- Craniofacial congenital disorders, including cleft lip and palate.
- History of periodontal disease
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Skeletal Anchored Maxillary Expander for Constricted Maxilla With Different Patient's Age (Cone Beam Computed Tomography Study)
The aim of study will be Evaluation of Effects of skeletal anchored maxillary expander for constricted maxilla with different patient's age
Read the detailed description
Various factors contribute to transverse deficiencies in the dental arch, which can present in several ways, including posterior crossbite, a collapsed maxillary arch, discrepancies in transverse dental arch, and cleft palate. Several devices and orthopedic approaches have been developed to address transverse maxillary constriction, which can be either surgical or non-surgical, and these devices may be either fixed or removable. Various types of anchorage can be utilized, such as tooth-borne anchorage with a hyrax or tooth-tissue-borne and bone-borne methods like mini-implant-assisted rapid palatal expander (MARPE). Rapid maxillary expansion (RME) is a frequently employed and dependable technique to rectify transverse maxillary deficiencies in prepubertal and adolescent individuals. RPE successfully treats both unilateral and bilateral buccal crossbites by expanding the maxilla by separating the midpalate suture. It works especially well for developing individuals with mixed dentition, but in older teenagers, it might cause side effects such buccal tilting of teeth and periodontal issues In post pubertal individuals (including young adults and adults), the use of rapid maxillary expansion (RME) techniques remains debated, as the median palatal suture is frequently matured and challenging to open clinically. As a result, these methods might lead to negative side effects, such as dentoalveolar compensation and adverse dental and periodontal outcomes in the affected teeth instead of genuine skeletal expansion.
Mini implant-assisted rapid maxillary expansion aims to achieve skeletal expansion of the palatal arch while minimizing the unwanted dental complications The Mini screw-assisted rapid palatal expansion, designed by Lee et al., functions as a tooth-bone-borne RPE-Hyrax device that is anchored in the palate with four Mini screws connected through helical loops that were soldered to the base of the expansion screw. These tiny screws were essential in allowing the midpalatal sutures to separate by applying the expansion force straight to the palate. MARPE is employed in both adolescents and adults as an alternative to surgically assisted rapid palatal expansion (SARPE). CBCT images showed an increase in skeletal dimensions in adult and adolescent patients treated with MARPE and a reduction in dental side effects. In recent years, Mini screw-assisted rapid palatal expansion (MARPE) has emerged as a highly effective method for achieving skeletal expansion of the maxilla in adolescents and adults, especially in cases where traditional rapid palatal expansion (RPE) may be limited due to increased suture interdigitation with age. MARPE enables orthopedic expansion without the need for surgical assistance in many cases The accuracy, adaptability, and efficiency of MARPE devices have significantly increased with the incorporation of 3D printing technology. Cone-beam computed tomography (CBCT) data and digital intraoral scans are used to construct 3D-printed MARPE appliances, enabling patient-specific designs that maximize comfort, fit, and biomechanical efficacy. Mini screw placement accuracy, better appliance adaptation to palate anatomy, and less chairside time are all made possible by the digital workflow.
The present trend in orthodontics toward individualized and technologically advanced treatment options is best illustrated by the combination of MARPE and 3D printing. By providing a more pleasant and effective treatment mode, this innovation not only improves clinical outcomes but also the patient experiences
.
- Conditions
- Maxillary Expansion
- Being tested
- Skeletal Anchored Maxillary Expander (MARPE)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skeletal Anchored Maxillary Expander (MARPE)Device
Mini implant assisted rapid maxillary expander (MARPE) used for skeletal maxillary expansion in adolescent and adult patients
| Study group | Role | What they receive |
|---|---|---|
| Adolescent group | Experimental | Not described Receives: Device: Skeletal Anchored Maxillary Expander (MARPE) |
| Adult group | Experimental | Not described Receives: Device: Skeletal Anchored Maxillary Expander (MARPE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal and dental changes after skeletal anchored maxillary expander for constricted maxilla in adolescent and adult patients constricted maxilla in adolescent and adult patients
changes in maxillary skeletal and dental arch width assessed by CBCT imaging before and after MARPE treatment.. evaluation includes skeletal expansion and transverse dental arch changes
Measured: from baseline (T0) to post expansion (T1)approximately 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary ExpansionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samar Hassan Mahmoud Mohamed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Samar Hassan Mahmoud Mohamed, Al-Azhar University
- Investigators
- Saleh Anwar Saleh, Professor of orthodontics, Study director, ALAzhar university ,faculty of dentistryEsmail Kamal Hewy, lecturer of orthodontics, Principal investigator, ALAzhar university ,faculty of dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07036822
- Sponsor's protocol ID
- Skeletal maxillary expansion
- Status last verified
- Jun 2025
- First submitted
- 17 Jun 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- 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 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Skeletal Anchored Maxillary Expander for Constricted Maxilla With Different Patient's Age (Cone Beam Computed Tomography Study)
- ClinicalTrials.gov ID
- NCT07036822
- Acronym / sponsor ID
- Skeletal maxillary expansion
- Conditions
- Maxillary Expansion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Samar Hassan Mahmoud MohamedUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 25 Jun 2025 (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.
The aim of study will be Evaluation of Effects of skeletal anchored maxillary expander for constricted maxilla with different patient's age
Detailed description
Various factors contribute to transverse deficiencies in the dental arch, which can present in several ways, including posterior crossbite, a collapsed maxillary arch, discrepancies in transverse dental arch, and cleft palate. Several devices and orthopedic approaches have been developed to address transverse maxillary constriction, which can be either surgical or non-surgical, and these devices may be either fixed or removable. Various types of anchorage can be utilized, such as tooth-borne anchorage with a hyrax or tooth-tissue-borne and bone-borne methods like mini-implant-assisted rapid palatal expander (MARPE). Rapid maxillary expansion (RME) is a frequently employed and dependable technique to rectify transverse maxillary deficiencies in prepubertal and adolescent individuals. RPE successfully treats both unilateral and bilateral buccal crossbites by expanding the maxilla by separating the midpalate suture. It works especially well for developing individuals with mixed dentition, but in older teenagers, it might cause side effects such buccal tilting of teeth and periodontal issues In post pubertal individuals (including young adults and adults), the use of rapid maxillary expansion (RME) techniques remains debated, as the median palatal suture is frequently matured and challenging to open clinically. As a result, these methods might lead to negative side effects, such as dentoalveolar compensation and adverse dental and periodontal outcomes in the affected teeth instead of genuine skeletal expansion.
Mini implant-assisted rapid maxillary expansion aims to achieve skeletal expansion of the palatal arch while minimizing the unwanted dental complications The Mini screw-assisted rapid palatal expansion, designed by Lee et al., functions as a tooth-bone-borne RPE-Hyrax device that is anchored in the palate with four Mini screws connected through helical loops that were soldered to the base of the expansion screw. These tiny screws were essential in allowing the midpalatal sutures to separate by applying the expansion force straight to the palate. MARPE is employed in both adolescents and adults as an alternative to surgically assisted rapid palatal expansion (SARPE). CBCT images showed an increase in skeletal dimensions in adult and adolescent patients treated with MARPE and a reduction in dental side effects. In recent years, Mini screw-assisted rapid palatal expansion (MARPE) has emerged as a highly effective method for achieving skeletal expansion of the maxilla in adolescents and adults, especially in cases where traditional rapid palatal expansion (RPE) may be limited due to increased suture interdigitation with age. MARPE enables orthopedic expansion without the need for surgical assistance in many cases The accuracy, adaptability, and efficiency of MARPE devices have significantly increased with the incorporation of 3D printing technology. Cone-beam computed tomography (CBCT) data and digital intraoral scans are used to construct 3D-printed MARPE appliances, enabling patient-specific designs that maximize comfort, fit, and biomechanical efficacy. Mini screw placement accuracy, better appliance adaptation to palate anatomy, and less chairside time are all made possible by the digital workflow.
The present trend in orthodontics toward individualized and technologically advanced treatment options is best illustrated by the combination of MARPE and 3D printing. By providing a more pleasant and effective treatment mode, this innovation not only improves clinical outcomes but also the patient experiences
.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adolescent group | Experimental | Device: Skeletal Anchored Maxillary Expander (MARPE) |
| Adult group | Experimental | Device: Skeletal Anchored Maxillary Expander (MARPE) |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Skeletal maxillary transverse deficiency.
- Unilateral or bilateral posterior crossbite. .Patient maintains good oral hygiene and overall health.
- Patient with no previous orthodontic treatment.
- No systemic disease that may affect bone quality or interfere with orthodontic treatment.
- Adolescent and adult patien
Key exclusion criteria (2 listed)
- Craniofacial congenital disorders, including cleft lip and palate.
- History of periodontal disease
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 |
|---|---|---|
| Skeletal Anchored Maxillary Expander (MARPE)Mini implant assisted rapid maxillary expander (MARPE) used for skeletal maxillary expansion in adolescent and adult patients | Device | Adolescent group, Adult group |
Primary outcome
Skeletal and dental changes after skeletal anchored maxillary expander for constricted maxilla in adolescent and adult patients constricted maxilla in adolescent and adult patients
Time frame: from baseline (T0) to post expansion (T1)approximately 3 months
changes in maxillary skeletal and dental arch width assessed by CBCT imaging before and after MARPE treatment.. evaluation includes skeletal expansion and transverse dental arch changes
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 27 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Maxillary Expansion
Not yet recruitingObservational study
Three-Dimensional Facial Soft Tissue Changes and Clinical Perception Following MARPE
Maxillary Transverse Deficiency
Not yet recruiting
Tooth-Borne (TBA) Versus Hybrid Expanders (HA) in Surgically Assisted Rapid Maxillary Expansion (SARME)
Maxillary Transverse Deficiency
Not yet recruiting
Evaluation of Occlusal Force Following Rapid Maxillary Expansion Assisted by Piezocision in Different Age Groups
Maxillary Transverse Deficiency, Rapid Maxillary Expansion
Recruiting
The Effectiveness of Early Intervention to Correct the Position of PDC:s
Ectopic Tooth Eruption, Palatal Expansion Technique
Active, not recruiting
Comparison of Laboratory-Fabricated and 3D-Printed Rapid Maxillary Expansion Appliances
Maxillary Constriction
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.
Saleh Anwar Saleh, Professor of orthodontics study director
ALAzhar university ,faculty of dentistry
Esmail Kamal Hewy, lecturer of orthodontics principal investigator
ALAzhar university ,faculty of dentistry
Questions about this trial
What is this clinical trial studying?
A study testing Skeletal Anchored Maxillary Expander (MARPE) in people with Maxillary Expansion, run by Samar Hassan Mahmoud Mohamed.
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 5 inclusion and 2 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 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Hassan Mahmoud Mohamed, BDS (01271677891, samarhassan1578@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skeletal and dental changes after skeletal anchored maxillary expander for constricted maxilla in adolescent and adult patients constricted maxilla in adolescent and adult patients (time frame: from baseline (T0) to post expansion (T1)approximately 3 months). 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 27 Jun 2025.