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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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.

Samar Hassan Mahmoud Mohamed, BDS contact

01271677891

samarhassan1578@gmail.com

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

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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 groups in NCT07036822
Study groupRoleWhat they receive
Adolescent groupExperimentalNot described
Receives: Device: Skeletal Anchored Maxillary Expander (MARPE)
Adult groupExperimentalNot 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.

  1. 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.

  1. First posted25 Jun 2025
  2. Study start1 Sep 2025 (estimated)
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion1 Dec 2027 (estimated)

Resources

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)
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

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.

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