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.
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
- Conditions the study is for
- Bone Anchored Miniscrew Assisted Rapid Palatal Expansion
- 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.
Egypt1 site, 1 recruiting
- Recruiting
faculty of dentistry- Mansoura University
Al Mansurah
Noheir samir ElShal, Phd, noheirelashall91@gmail.com
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:
- 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.
- 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:
- Photographs (Extraoral and Intraoral)
- Upper and lower plaster casts.
- 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:
- For the pre-expansion images, the axial view will be chosen to determine the maturation stage of MPS and will be recorded.
- 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 group | Role | What they receive |
|---|---|---|
| bone anchored miniscrew assisted rapid palatal expansion | Experimental | placement 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.
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
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
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.
- First posted9 Jan 2026
- Study start20 Jun 2025
- Primary completion20 Jun 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Anchored Miniscrew Assisted Rapid Palatal ExpansionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Radwan, Mansoura University
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The The Effect of 3D Printed Framework Bone-Borne Rapid Maxillary Expander in Young Adults: a CBCT Study
- ClinicalTrials.gov ID
- NCT07331207
- Acronym / sponsor ID
- Mansoura_University
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- 20 Jun 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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:
- Photographs (Extraoral and Intraoral)
- Upper and lower plaster casts.
- 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:
- For the pre-expansion images, the axial view will be chosen to determine the maturation stage of MPS and will be recorded.
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bone anchored miniscrew assisted rapid palatal expansion | Experimental | Device: bone anchored miniscrew assisted rapid palatal expansionplacement 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bone anchored miniscrew assisted rapid palatal expansionskeletal rapid maxillary arch expansion | Device | bone anchored miniscrew assisted rapid palatal expansion |
Primary outcome
Tooth inclination
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.
mid-palatal suture expansion
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.
Buccal alveolar bone thickness
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.