Palatal Expansion TechniqueNCT05543460
Miniscrew-assisted Rapid Palatal Expansion With and Without Corticopuncture
A study testing MARPE with Corticopunctures and MARPE in people with Palatal Expansion Technique and Posterior Crossbite, run by Alexandria University at 1 site in Egypt.
Trial summary
Rapid palatal expansion aims at skeletally correcting the transverse maxillary deficiency by applying forces to separate the mid-palatal suture. In adult patients, the separation of the mid-palatal suture may not be possible due to its increased interdigitation. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Palatal Expansion Technique, Posterior Crossbite, Maxillary Hypoplasia
- What is being tested?
- MARPE with Corticopunctures and MARPE
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2022to 1 Mar 2024
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Suture maturation stage D or E according to the method of Angelieri et al. (Angelieri F, Cevidanes LH, Franchi L, Goncalves JR, Benavides E, McNamara JA, Jr. Midpalatal suture maturation: classification method for individual assessment before rapid maxillary expansion. Am J Orthod Dentofacial Orthop. 2013;144(5):759-69.)
- Maxillary transverse deficiency measured using the method of Cantarella et al. (Cantarella D, Dominguez-Mompell R, Mallya SM, Moschik C, Pan HC, Miller J, et al. Changes in the midpalatal and pterygopalatine sutures induced by micro-implant-supported skeletal expander, analyzed with a novel 3D method based on CBCT imaging. Prog Orthod. 2017;18(1):34.)
- Good oral hygiene (Score <2 based on the Simplified Oral Hygiene Index (OHI-S)). (Greene JC, Vermillion JR. The Simplified Oral Hygiene Index. J Am Dent Assoc. 1964;68:7-13.)
Who cannot join
- History of previous orthodontic or orthopedic treatment.
- History of facial trauma or surgery.
- Patients with congenital craniofacial malformations or diagnosed syndromes.
- Medical history that prohibits the surgical intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Miniscrew-assisted Rapid Palatal Expansion With and Without Corticopuncture in Adults: A Randomized Clinical Trial
Rapid palatal expansion aims at skeletally correcting the transverse maxillary deficiency by applying forces to separate the mid-palatal suture. In adult patients, the separation of the mid-palatal suture may not be possible due to its increased interdigitation. Miniscrew-assisted rapid maxillary expansion (MARPE) was proposed to transmit the forces directly to the mid-palatal suture through palatal miniscrews in addition to the anchor teeth. However, some non-growing patients may not respond favorably to MARPE. Hence, the use of corticopunctures as an adjunct to MARPE was recently proposed to overcome the increased resistance of the sutures in adult patients.
The study aims to assess and compare the skeletal and dental effects of miniscrew-assisted rapid palatal expansion with and without corticopunctures in non-growing patients.
Read the detailed description
Rapid palatal expansion is a common treatment modality that aims at skeletally correcting the transverse maxillary deficiency by applying forces to separate the mid-palatal suture. In adult patients, the separation of the mid-palatal suture may not be possible due to its increased interdigitation and ossification. Miniscrew-assisted rapid maxillary expansion (MARPE) was proposed to transmit the forces directly to the mid-palatal suture through palatal miniscrews in addition to the anchor teeth. However, some non-growing patients may not respond favorably to MARPE. Hence, the use of corticopunctures as an adjunct to MARPE was recently proposed to overcome the increased resistance of the ossified mid-palatal sutures in adult patients.
The aim of the study is to assess and compare the skeletal and dental effects of miniscrew-assisted rapid palatal expansion with and without corticopunctures in non-growing patients.
A randomized clinical trial will be conducted to address the aim of the study. Patients will be randomly and equally assigned to group 1 (Corticopuncture-facilitated MARPE) or group 2 (Conventional MARPE). Both groups will be treated using Maxillary Skeletal Expander (MSE II, Biomaterials Korea Inc., Seoul, Korea). Ten corticopunctures will be made in group 1 along the mid-palatal suture with the aid of a 3D printed surgical guide. The skeletal and dental changes will be assessed using cone beam computed tomography scans obtained before treatment and after 6 months of expansion stabilization. The results will be compared between the groups and analyzed using the appropriate statistical tests.
- Being tested
- MARPE with Corticopunctures, MARPE
- Keywords
- Rapid palatal expansion, Maxillary Skeletal Expander, Corticopunctures, MARPE
- Medical subject headings
- Retrognathia, Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MARPE with CorticopuncturesProcedure or surgery
Maxillary Skeletal Expander (MSE II, Biomaterials Korea Inc., Seoul, Korea) used to correct the maxillary transverse deficiency aided with corticopunctures made along the mid-palatal suture
MARPEDevice
Maxillary Skeletal Expander (MSE II, Biomaterials Korea Inc., Seoul, Korea) used to correct the maxillary transverse deficiency
| Study group | Role | What they receive |
|---|---|---|
| Corticopuncture-facilitated MARPE | Experimental | Patients will be treated using Maxillary Skeletal Expander (MSE II, Biomaterials Korea Inc., Seoul, Korea) with corticopunctures .along the mid-palatal suture Receives: Procedure: MARPE with Corticopunctures |
| Conventional MARPE | Active comparator | Patients will be treated using Maxillary Skeletal Expander (MSE II, Biomaterials Korea Inc., Seoul, Korea) without corticopunctures. Receives: Device: MARPE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transverse skeletal changes from baseline to an average of 6 months after the initial activation, measured using cone beam computed tomography (CBCT)
The data from CBCT scans at the different time points will be exported in Digital Imaging and Communications in Medicine (DICOM) format and processed using suitable software. The relevant landmarks will be defined and located by the investigator to measure the transverse skeletal changes in mm from baseline to the end of passive retention of the expansion.
Measured: At baseline and an average of 6 months after the initial activation
Secondary outcomes (1)
Dento-alveolar inclination changes from baseline to an average of 6 months after the initial activation, measured using CBCT
The data from CBCT scans at the different time points will be exported in DICOM format and processed using suitable software. The relevant landmarks will be defined and located by the investigator to measure the changes in dentoalveolar inclination from baseline to the end of passive retention of the expansion.
Measured: At baseline and an average of 6 months after the initial activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start1 Aug 2022
- Primary completion1 Nov 2023
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Palatal Expansion TechniqueStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yomna Mohamed Mohamed Yacout, Alexandria University
- Investigators
- Yomna M Yacout, MSc, PhD, Principal investigator, Alexandria UniversityEiman S Marzouk, MSc, PhD, Study chair, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05543460
- Sponsor's protocol ID
- 0489-8/2022
- Status last verified
- Sep 2022
- First submitted
- 14 Sep 2022
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Suzuki SS, Braga LFS, Fujii DN, Moon W, Suzuki H. Corticopuncture Facilitated Microimplant-Assisted Rapid Palatal Expansion. Case Rep Dent. 2018 Dec 6;2018:1392895. doi: 10.1155/2018/1392895. eCollection 2018.
PubMed 30627452Bud ES, Bica CI, Pacurar M, Vaida P, Vlasa A, Martha K, Bud A. Observational Study Regarding Possible Side Effects of Miniscrew-Assisted Rapid Palatal Expander (MARPE) with or without the Use of Corticopuncture Therapy. Biology (Basel). 2021 Mar 3;10(3):187. doi: 10.3390/biology10030187.
PubMed 33802266Angelieri F, Cevidanes LH, Franchi L, Goncalves JR, Benavides E, McNamara JA Jr. Midpalatal suture maturation: classification method for individual assessment before rapid maxillary expansion. Am J Orthod Dentofacial Orthop. 2013 Nov;144(5):759-69. doi: 10.1016/j.ajodo.2013.04.022.
PubMed 24182592Cantarella D, Dominguez-Mompell R, Mallya SM, Moschik C, Pan HC, Miller J, Moon W. Changes in the midpalatal and pterygopalatine sutures induced by micro-implant-supported skeletal expander, analyzed with a novel 3D method based on CBCT imaging. Prog Orthod. 2017 Nov 1;18(1):34. doi: 10.1186/s40510-017-0188-7.
PubMed 29090368GREENE JC, VERMILLION JR. THE SIMPLIFIED ORAL HYGIENE INDEX. J Am Dent Assoc. 1964 Jan;68:7-13. doi: 10.14219/jada.archive.1964.0034. No abstract available.
PubMed 14076341
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Miniscrew-assisted Rapid Palatal Expansion With and Without Corticopuncture in Adults: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05543460
- Acronym / sponsor ID
- 0489-8/2022
- Keywords
- Rapid palatal expansion, Maxillary Skeletal Expander, Corticopunctures, MARPE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 16 Sep 2022 (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.
Rapid palatal expansion aims at skeletally correcting the transverse maxillary deficiency by applying forces to separate the mid-palatal suture. In adult patients, the separation of the mid-palatal suture may not be possible due to its increased interdigitation. Miniscrew-assisted rapid maxillary expansion (MARPE) was proposed to transmit the forces directly to the mid-palatal suture through palatal miniscrews in addition to the anchor teeth. However, some non-growing patients may not respond favorably to MARPE. Hence, the use of corticopunctures as an adjunct to MARPE was recently proposed to overcome the increased resistance of the sutures in adult patients.
The study aims to assess and compare the skeletal and dental effects of miniscrew-assisted rapid palatal expansion with and without corticopunctures in non-growing patients.
Detailed description
Rapid palatal expansion is a common treatment modality that aims at skeletally correcting the transverse maxillary deficiency by applying forces to separate the mid-palatal suture. In adult patients, the separation of the mid-palatal suture may not be possible due to its increased interdigitation and ossification. Miniscrew-assisted rapid maxillary expansion (MARPE) was proposed to transmit the forces directly to the mid-palatal suture through palatal miniscrews in addition to the anchor teeth. However, some non-growing patients may not respond favorably to MARPE. Hence, the use of corticopunctures as an adjunct to MARPE was recently proposed to overcome the increased resistance of the ossified mid-palatal sutures in adult patients.
The aim of the study is to assess and compare the skeletal and dental effects of miniscrew-assisted rapid palatal expansion with and without corticopunctures in non-growing patients.
A randomized clinical trial will be conducted to address the aim of the study. Patients will be randomly and equally assigned to group 1 (Corticopuncture-facilitated MARPE) or group 2 (Conventional MARPE). Both groups will be treated using Maxillary Skeletal Expander (MSE II, Biomaterials Korea Inc., Seoul, Korea). Ten corticopunctures will be made in group 1 along the mid-palatal suture with the aid of a 3D printed surgical guide. The skeletal and dental changes will be assessed using cone beam computed tomography scans obtained before treatment and after 6 months of expansion stabilization. The results will be compared between the groups and analyzed using the appropriate statistical tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corticopuncture-facilitated MARPE | Experimental | Procedure: MARPE with CorticopuncturesPatients will be treated using Maxillary Skeletal Expander (MSE II, Biomaterials Korea Inc., Seoul, Korea) with corticopunctures .along the mid-palatal suture |
| Conventional MARPE | Active comparator | Device: MARPEPatients will be treated using Maxillary Skeletal Expander (MSE II, Biomaterials Korea Inc., Seoul, Korea) without corticopunctures. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Suture maturation stage D or E according to the method of Angelieri et al. (Angelieri F, Cevidanes LH, Franchi L, Goncalves JR, Benavides E, McNamara JA, Jr. Midpalatal suture maturation: classification method for individual assessment before rapid maxillary expansion. Am J Orthod Dentofacial Orthop. 2013;144(5):759-69.)
- Maxillary transverse deficiency measured using the method of Cantarella et al. (Cantarella D, Dominguez-Mompell R, Mallya SM, Moschik C, Pan HC, Miller J, et al. Changes in the midpalatal and pterygopalatine sutures induced by micro-implant-supported skeletal expander, analyzed with a novel 3D method based on CBCT imaging. Prog Orthod. 2017;18(1):34.)
- Good oral hygiene (Score <2 based on the Simplified Oral Hygiene Index (OHI-S)). (Greene JC, Vermillion JR. The Simplified Oral Hygiene Index. J Am Dent Assoc. 1964;68:7-13.)
Key exclusion criteria (4 listed)
- History of previous orthodontic or orthopedic treatment.
- History of facial trauma or surgery.
- Patients with congenital craniofacial malformations or diagnosed syndromes.
- Medical history that prohibits the surgical intervention.
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 |
|---|---|---|
| MARPE with CorticopuncturesMaxillary Skeletal Expander (MSE II, Biomaterials Korea Inc., Seoul, Korea) used to correct the maxillary transverse deficiency aided with corticopunctures made along the mid-palatal suture | Procedure or surgery | Corticopuncture-facilitated MARPE |
| MARPEMaxillary Skeletal Expander (MSE II, Biomaterials Korea Inc., Seoul, Korea) used to correct the maxillary transverse deficiency | Device | Conventional MARPE |
Primary outcome
Transverse skeletal changes from baseline to an average of 6 months after the initial activation, measured using cone beam computed tomography (CBCT)
Time frame: At baseline and an average of 6 months after the initial activation
The data from CBCT scans at the different time points will be exported in Digital Imaging and Communications in Medicine (DICOM) format and processed using suitable software. The relevant landmarks will be defined and located by the investigator to measure the transverse skeletal changes in mm from baseline to the end of passive retention of the expansion.
1 secondary outcome
Dento-alveolar inclination changes from baseline to an average of 6 months after the initial activation, measured using CBCT
Time frame: At baseline and an average of 6 months after the initial activation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Background: PubMed 30627452Suzuki SS, Braga LFS, Fujii DN, Moon W, Suzuki H. Corticopuncture Facilitated Microimplant-Assisted Rapid Palatal Expansion. Case Rep Dent. 2018 Dec 6;2018:1392895. doi: 10.1155/2018/1392895. eCollection 2018.
- Background: PubMed 33802266Bud ES, Bica CI, Pacurar M, Vaida P, Vlasa A, Martha K, Bud A. Observational Study Regarding Possible Side Effects of Miniscrew-Assisted Rapid Palatal Expander (MARPE) with or without the Use of Corticopuncture Therapy. Biology (Basel). 2021 Mar 3;10(3):187. doi: 10.3390/biology10030187.
- Background: PubMed 24182592Angelieri F, Cevidanes LH, Franchi L, Goncalves JR, Benavides E, McNamara JA Jr. Midpalatal suture maturation: classification method for individual assessment before rapid maxillary expansion. Am J Orthod Dentofacial Orthop. 2013 Nov;144(5):759-69. doi: 10.1016/j.ajodo.2013.04.022.
- Background: PubMed 29090368Cantarella D, Dominguez-Mompell R, Mallya SM, Moschik C, Pan HC, Miller J, Moon W. Changes in the midpalatal and pterygopalatine sutures induced by micro-implant-supported skeletal expander, analyzed with a novel 3D method based on CBCT imaging. Prog Orthod. 2017 Nov 1;18(1):34. doi: 10.1186/s40510-017-0188-7.
- Background: PubMed 14076341GREENE JC, VERMILLION JR. THE SIMPLIFIED ORAL HYGIENE INDEX. J Am Dent Assoc. 1964 Jan;68:7-13. doi: 10.14219/jada.archive.1964.0034. No abstract available.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Yomna M Yacout, MSc, PhD principal investigator
Alexandria University
Eiman S Marzouk, MSc, PhD study chair
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MARPE with Corticopunctures and MARPE in people with Palatal Expansion Technique and Posterior Crossbite, run by Alexandria 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 3 inclusion and 4 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 2 Oct 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?
Transverse skeletal changes from baseline to an average of 6 months after the initial activation, measured using cone beam computed tomography (CBCT) (time frame: At baseline and an average of 6 months after the initial activation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05543460, which also lists 5 linked publications.
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 2 Oct 2025.