Mansura University, Faculty of Dentistry
Al Mansurah, Al Dakhelia, 7650001, Egypt
NCT Number: NCT07075211
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.
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Notify Me15 year and older
All sexes
Interventional
Not applicable
Al Mansurah, Al Dakhelia, 7650001, Egypt
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
Treatment procedure:
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.
Immediate 2 turns activation will be made in the hyrax after fitting the appliance.
Records:
For all patients the following records are made:
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
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.
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.
At the following setting:
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:
For the second premolar: in the most anterior section showing maximum length of its root.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
MARPE (mini-screw assisted rapid palatal expansion) with two min screws in post-pubertal patients
Time frame: 3 weeks in each participant
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
Mansoura University
Other
Acronym: EMARPEMSPP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.