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Constricted Maxillary ArchEMARPEMSPPNCT07075211

Effect of Mini-screw Assisted Rapid Palatal Expansion on Midpalatal Suture in Post-pubertal Patients: a CBCT Study

A study testing MARPE (mini-screw assisted rapid palatal expansion) in people with Constricted Maxillary Arch, run by Mansoura University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

a device is going to be placed in the palate to non-growing patients who are diagnosed to have a constricted maxillary arch and require an expansion of the maxillary arch in their treatment plan. Read more about this study

Who is it for?
Ages 15 years and olderHealthy volunteers can take part
Conditions the study is for
Constricted Maxillary Arch
What is being tested?
MARPE (mini-screw assisted rapid palatal expansion)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteEgypt
Study dates
1 May 2024to 1 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

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 15 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Transverse maxillary deficiency with or without crossbite; who requires maxillary expansion in their treatment plan as described by Tamburino et al.3
  • Age after 16.
  • 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.
  • All patients were signed a written consent after accepting the treatment plan.

Who cannot join

  • Patients under the age of 16 years.
  • Absence of first and second upper premolars and first upper molars.
  • Previous orthodontic treatment
  • Periodontal disease and poor oral hygiene
  • significant dentofacial anomalies, any bone defects, or systemic disease.
  • Pregnant
  • Those who did not consent to participate in this study.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Mansura University, Faculty of Dentistry

    Al Mansurah, Al Dakhelia, 7650001

Other trials in Egypt

About this study

a device is going to be placed in the palate to non-growing patients who are diagnosed to have a constricted maxillary arch and require an expansion of the maxillary arch in their treatment plan. the device is composed of two mini screws that will be placed in the palate which are connected to a hyrax with orthodontic bands on first maxillary molars. the activation of the device will be for 3 weeks 2 turns on the day of placement and 1 turn every day for 3 weeks. a CBCT x-ray will be taken before and after expansion to see the effect of MARPE on the mid-palatal suture.

Read the detailed description

The aim of this study is to assess the effect of MARPE on MPS in post-pubertal patients using two mini-screws, evaluated by CBCT.

The sample will consist of 14 patients. They will be selected from the Orthodontic Department, Faculty of Dentistry, Mansuora University according to the following:

Inclusion criteria:

  • Transverse maxillary deficiency with or without crossbite; who requires maxillary expansion in their treatment plan as described by Tamburino et al.19
  • Age after 16.
  • 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.
  • All patients are signed a written consent after accepting the treatment plan.

Treatment procedure:

  • First visit: Thorough explanation of procedures to the patient, clarifying all details and technical limitations and informing that failure may occur; placement of elastic separators on mesial and distal side of permanent maxillary first molars.
  • Second visit: The elastic separators will be removed and a proper size of orthodontic bands will be placed in permanent maxillary first molars. After LA infiltration in the palate a two OrthoEasy Pal mini-screw from Forestadent size 8* 1.7 mm will be placed paramedian 3mm away from the midpalatal suture between the first and second premolar area,20 using a manual drive attachment for contra-angle handpiece and attached to OrthoEasy blade 10 mm Octagonal. After the placement of mini-screws in the desired location; two OrthoEasy Pal impression caps will be placed on the head of the mini-screws. After that, an impression will be taken using putty silicone impression material, the molar bands will be removed from patient's mouth using orthodontic band removal plier and placed in the impression tray. Also the impression cap will be removed from the patient's mouth and placed in the impression tray. Elastic separators on mesial and distal side of permanent maxillary first molars will be placed again.

The impression tray will be sent to the lab for MARPE fabrication.

Laboratory steps:

Before pouring the impression with regular white dental plaster, the impression caps will be removed from the impression tray and two OrthoEasy Pal lab analogs will be placed instead.

The impression will be poured with regular white dental plaster. 10 mm of palatal expansion screw from Forestadent will be selected according to the palatal width. The posterior wires will be bent to reach the orthodontic bands and soldered to it, while the anterior wires will be soldered to the OrthoEasy Pal abutment (flat profile) which will be placed on the cast on top of the duplicated mini-screw heads. followed by finishing and polishing of the device.

  • Third visit: The elastic separators will be removed and the device will be placed to check its fitting. Once fitting is checked, cementation of the bands of the device to the first molar will be performed using glass ionomer cementation (GIC). 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 per day for 3 weeks. After 3 weeks a cbct image will be taken to assess the MPS. Fixed appliance will be placed after 3-4 months period of retention.
  • Activation will be discontinued when the lingual cusps of the upper first molars contacted the buccal cusps of the lower first molars.

Records:

For all patients the following records are made:

  1. Photographs:
  2. Extraoral
  3. Intraoral
  4. Upper and lower plaster casts.
  5. Radiographs:
  6. Panoramic radiography.
  7. Lateral cephalometric.
  8. Cone-beam computed tomography systems (CBCT).

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

Upper and lower diagnostic casts will be taken once, pre- operative.

Lateral cephalometric and panoramic radiography will be taken once; pre operative. CBCT will be taken twice; pre-expansion and after 3 weeks from the first activation

  1. Extra-oral and Intra-oral photographs: Extraoral photographs of the face in frontal and lateral views are taken. The frontal view is taken with the interpupillary line parallel to the floor and the midsagittal plane is perpendicular to the floor. The lateral view (left side) is taken after adjusting the Frankfort horizontal plane to be parallel to the the floor. on the other hand, the intraoral photographs are taken in frontal, lateral and occlusal views.
  2. Upper and lower casts: Upper and lower impressions of the dental arches will be taken using Alginate impression material.They will be poured immediately in a white dental plaster. A wax bite is obtained in centric occlusion to orient the upper and lower casts. The models are identified with the name of the patient, date of birth, and date of taking the impression.
  3. Radiographs:
  4. Lateral cephalometric radiograph: Lateral cephalometric radiographs are done before treatment as a diagnostic aids and to record the cervical vertebrae maturation.11
  5. Panoramic radiographs: Panoramic radiographs are taken before treatment as a diagnostic aids and to determine any pathological abnormalities that can hinder the study.
  6. Cone-beam computed tomography systems (CBCT): CBCT image (Soredex Cranex 3Dx) will be taken before expansion to record the stage of mid palatal suture21 and to assess the MPS. Another image will be taken after 3 weeks 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 puplished reseach, CBCT scans were taken before expansion (T1) and 1 week after active expansion (T2).22Another puplished research took CBCT scans before expansion (T1) and 10 days after active expansion (T2). 23 The CBCT setting will be reduced as much as possible with small field of view following the low dose protocol with the help of a radiologist from Mansuura university to ensure that the total radiation of repeated CBCT imaging during the experiment doesn't exceed the recommended annual dose limit (1 mSv).24

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

CBCT analysis

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 weeks 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 weeks from the first activation
Being tested
MARPE (mini-screw assisted rapid palatal expansion)

What participants receive

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

  • MARPE (mini-screw assisted rapid palatal expansion)Device

    MARPE (mini-screw assisted rapid palatal expansion) with two min screws in post-pubertal patients

Study groups in NCT07075211
Study groupRoleWhat they receive
participants who received MARPEExperimentalparticipants who received MARPE
Receives: Device: MARPE (mini-screw assisted rapid palatal expansion)

What is being measured

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

  1. CBCT analysis : the mid palatal suture opening will be assessed from the axial slice.

    CBCT analysis: the mid palatal suture opening will be measures in millimetres at three different sites ( first premolar , second premolar, first molar). the metric measure will be placed at the two ends of the mid palatal suture

    Measured: 3 weeks in each participant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2025
  2. Study start1 May 2024
  3. Primary completion1 May 2025
  4. Study completion1 Jun 2025

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
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07075211
Sponsor's protocol ID
A0803024OR
Acronym
EMARPEMSPP
Status last verified
Jul 2025
First submitted
15 Jun 2025
Last updated
20 Jul 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing MARPE (mini-screw assisted rapid palatal expansion) in people with Constricted Maxillary Arch, 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 8 inclusion and 7 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: finished, as of the sponsor's last update on 20 Jul 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CBCT analysis : the mid palatal suture opening will be assessed from the axial slice. (time frame: 3 weeks in each participant). 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 20 Jul 2025.

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