faculty of dentistry- Mansoura University
Al Mansurah, Egypt
Location status: Recruiting
NCT Number: NCT07331207
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.
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.
Interested in participating?
Request Info18 year–30 year
All sexes
Interventional
Not applicable
Al Mansurah, Egypt
Location status: Recruiting
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:
Laboratory steps:
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
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:
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
skeletal rapid maxillary arch expansion
Time frame: 3 months
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.
Time frame: 3 months
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.
Time frame: 3 months
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
Contact information is provided by the study sponsor or research team.
Mansoura University
Other
The The Effect of 3D Printed Framework Bone-Borne Rapid Maxillary Expander in Young Adults: a CBCT Study
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