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Bone Anchored Miniscrew Assisted Rapid Palatal ExpansionNCT07331207

The Effect of 3D Printed Framework Bone-Borne Rapid Maxillary Expander in Young Adults

A study testing bone anchored miniscrew assisted rapid palatal expansion in people with Bone Anchored Miniscrew Assisted Rapid Palatal Expansion, run by Mansoura University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Aim of the study: assess the effect of printed framework pure bone-born rapid maxillary expanders on MPS. Materials and Methods: The intra-oral scan and CBCT will be sent to the lab for MARPE fabrication, four mini-screws size 10mm in length, and 1.7 mm in diameter will be placed, after that, the device will be… Read more about this study

Who is it for?
Ages 18 to 30 years
What is being tested?
bone anchored miniscrew assisted rapid palatal expansion
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteEgypt
Study dates
20 Jun 2025to 1 Jul 2026
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 18 to 30 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Transverse maxillary deficiency with or without crossbite; who requires maxillary expansion
  • Age: (18 to 30) years.
  • presence of first and second upper premolars and first upper molars
  • No previous orthodontic treatment.
  • Good oral hygiene and healthy periodontal tissue.
  • No significant dentofacial anomalies, any bone defects, or systemic disease.
  • Not being pregnant.

Who cannot join

  • previous orthodontic treatment.
  • significant dentofacial anomalies, any bone defects, or systemic disease.
  • pregnant.
  • bad oral hygiene and healthy periodontal tissue.
  • loss first and second upper premolars and first upper molars
  • growing patients

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mohammad Radwan Alrefai, dentist contact

01029054360 ext. +20

mhmd1alrifai@gmail.com

Egypt1 site, 1 recruiting
  • faculty of dentistry- Mansoura University

    Al Mansurah

    Noheir samir ElShal, Phd, noheirelashall91@gmail.com

    Recruiting

Other trials in Egypt

About this study

Official title: The The Effect of 3D Printed Framework Bone-Borne Rapid Maxillary Expander in Young Adults: a CBCT Study

Aim of the study: assess the effect of printed framework pure bone-born rapid maxillary expanders on MPS.

Materials and Methods: The intra-oral scan and CBCT will be sent to the lab for MARPE fabrication, four mini-screws size 10mm in length, and 1.7 mm in diameter will be placed, after that, the device will be retained to the mini-screws by retaining screw. The activation of MARPE will be 1 turn (0.25 mm per turn) per day. After 3 months, a CBCT image will be taken to assess the MPS.

Read more

Outcomes:

CBCT analysis: For the first premolar and the first molar: points will be made at the most anterior section where the crown and palatal root can be seen at their greatest length. For the second premolar: in the most anterior section showing maximum length of its root. Measuring the distance between the external right and left maxilla edges in the axial view before expansion and after 3 months from the first activation. Tooth inclination will be measured using the coronal section at a point on the most anterior section, where the crown and the mesiobuccal root can be seen at their greatest length. Buccal alveolar bone thickness measurements were made from the outermost point of the bones to the mesiobuccal root at the level of the furcation point, and fenestration were also evaluated.

Read the detailed description

Aim of the study: to assess the effect of printed framework pure bone-born rapid maxillary expanders on MPS, dental inclination and buccal bone thickness in young adult patients.

Materials and Methods:

Sample size calculation: Sample size calculation was based on effect Effect of 3D Printed Framework Pure Bone-Born Rapid Maxillary Expanders midpalatal suture that was retrived from previous research (Tanga et al. , 2011). Using G power program version 3.1.9.7 to calculate sample size based on effect size of 0,89 using 2-tailed test , α error =0.05 and power = 85%, the total calculated sample size will be 16.

Treatment procedure:

  • First visit: Thorough explanation of procedures to the patient, clarifying all details and technical limitations and informing that failure may occur; Taking intra-oral scan (Medit i700).
  • The Scan and CBCT will be sent to the lab for MARPE fabrication.
  • Second visit: Surgical guide will be placed. After LA infiltration in the palate, a four OrthoEasy Pal mini-screw from Forestadent size 10mm in length, and 1.8 mm in diameter will be placed, using a manual drive attachment for contra-angle handpiece and attached to OrthoEasy blade 10 mm Octagonal.
  • After the placement of four OrthoEasy mini-screws in the desired location; the 2 anterior mini-implants will be place paramedian in the anterior palate usually around the third Rugae line, in area commonly described as the T-Zone. The 2 posterior mini-implants will be placed in the alveolar process between the second premolar and first molar roots at approximately 8-9 mm from the gingival margin. as seen in (figure1); device will be placed.
  • After that, the OrthoEasy Pal abutments of the device will be retained to the mini-screws by OrthoEasy Pal Retaining screw using blade for OrthoEasy Pal retaining screw for contra-angle handpiece.
  • Immediate 2 turns activation will be made in the hyrax after fitting the appliance.
  • The activation protocol of MARPE will be 1 turn (0.25 mm per turn) per day.
  • The expansion will be completed when the maxillary width overlaps the mandibular width, achieving normal occlusion.
  • After 3 months, a CBCT image will be taken to assess the MPS. The rapid maxillary expander will be removed after 3 months period of retention.

Laboratory steps:

  1. Scan and CBCT overlapping using OnyxCeph program First the mini screw placed on their position digitally and then fabrication the digital design of MARPE. The process will be completed by printing the design by using (Riton, Dual-150) machine and welding the hyrax to it, followed by finishing and polishing of the device.
  2. In the separate step, the surgical guide will be fabricated digitally according to mini screw position

Records:

For all patients the following records are made:

  1. Photographs (Extraoral and Intraoral)
  2. Upper and lower plaster casts.
  3. Radiographs ( Panoramic radiography, Lateral cephalometric and Cone-beam computed tomography systems).

Photographs will be taken 3 times; pre-operative, after MARPE placement and after 3 weeks from the first activation

Cone-beam computed tomography systems (CBCT):

CBCT image (Soredex Cranex 3Dx) will be taken before expansion to record the stage of mid palatal suture and to assess the MPS. Another image will be taken after 3 months from the first activation for evaluating the mid-palatal suture. At the following setting:

  • Exposure time: 9 s, 4.0mA, 89kV, field of view [FOV]: 8*15 cm voxel size: 0.32 mm).

According to a previous published research, CBCT scans were taken before expansion (T1) and 1 week after active expansion (T2).

Digital Imaging and Communications in Medicine (DICOM) file image reconstruction and analysis will be performed with OsiriX Lite software.

outcomes:

For CBCT analysis; the following will be determined:

  • dimensional reference planes for craniofacial structures orientation and to standardize linear measurements in the axial plane:
  • In the axial plane, the mid-palatine suture will be used.
  • In the mid-sagittal plane. the horizontal palatal plane will be the selected reference
  • In the coronal plane, the image was oriented perpendicular to the patient's midsagittal plane tangent to the most inferior level of nasal floor at the level of first molar where the crown and palatal root can be seen at their greatest length.
  • After the image is oriented:
  1. For the pre-expansion images, the axial view will be chosen to determine the maturation stage of MPS and will be recorded.
  2. In both pre-expansion and after 3 months from the first activation images; points will be marked in the axial plane at 3 different locations assisted from coronal plane: first premolar, second premolar and first molar.
  • For the first premolar and the first molar: points will be made at the most anterior section where the crown and palatal root can be seen at their greatest length. For the second premolar: in the most anterior section showing maximum length of its root.
  • Measuring the distance between the external right and left maxilla edges in the axial view before expansion and after 3 months from the first activation.
  • Tooth inclination will be measured using the coronal section (describe for each tooth side R and L) at a point on the most anterior section, where the crown and the mesiobuccal root can be seen at their greatest length. Angle formed by the intersection of two tangents that passes through the central fossa of upper first molar and through the furcation area, to the transversal line at the level of the palate.
  • Buccal alveolar bone thickness measurements were made from the outermost point of the bones to the mesiobuccal root at the level of the furcation point
Being tested
bone anchored miniscrew assisted rapid palatal expansion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bone anchored miniscrew assisted rapid palatal expansionDevice

    skeletal rapid maxillary arch expansion

Study groups in NCT07331207
Study groupRoleWhat they receive
bone anchored miniscrew assisted rapid palatal expansionExperimentalplacement of four mini-screws in the desired location; the 2 anterior mini-implants will be place paramedian in the anterior palate usually around the third Rugae line. The 2 posterior mini-implants will be placed in the alveolar process between the second premolar and first molar roots at approximately 8-9 mm from the gingival margin. After that, the device will be retained to the mini-screws by retaining screw.
Receives: Device: bone anchored miniscrew assisted rapid palatal expansion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tooth inclination

    Tooth inclination will be measured using the coronal section (describe for each tooth side R and L) at a point on the most anterior section, where the crown and the mesiobuccal root can be seen at their greatest length. Angle formed by the intersection of two tangents that passes through the central fossa of upper first molar and through the furcation area, to the transversal line at the level of the palate.

    Measured: 3 months

  2. mid-palatal suture expansion

    Measuring the distance between the external right and left maxilla edges in the axial view before expansion and after 3 months from the first activation.

    Measured: 3 months

  3. Buccal alveolar bone thickness

    Buccal alveolar bone thickness measurements were made from the outermost point of the bones to the mesiobuccal root at the level of the furcation point

    Measured: 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 posted9 Jan 2026
  2. Study start20 Jun 2025
  3. Primary completion20 Jun 2026 (estimated)
  4. Study completion1 Jul 2026 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07331207
Sponsor's protocol ID
Mansoura_University
Status last verified
Dec 2025
First submitted
29 Dec 2025
Last updated
9 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing bone anchored miniscrew assisted rapid palatal expansion in people with Bone Anchored Miniscrew Assisted Rapid Palatal Expansion, run by Mansoura 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 7 inclusion and 6 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 9 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 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 Mohammad Radwan Alrefai, dentist (01029054360 ext. +20, mhmd1alrifai@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tooth inclination (time frame: 3 months). The study lists 3 primary outcomes in all. 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 9 Jan 2026.

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