- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05543460
Miniscrew-assisted Rapid Palatal Expansion With and Without Corticopuncture
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yomna M Yacout, MSc, PhD
- Phone Number: 2034868066
- Email: yomna.yacout@alexu.edu.eg
Study Contact Backup
- Name: Yasmine M Mahmoud, MSc
- Phone Number: 2034868066
- Email: Jasymme@yahoo.com
Study Locations
-
-
-
Alexandria, Egypt
- Recruiting
- Faculty of Dentistry, Alexandria University
-
Contact:
- Yomna M Yacout, MSc, PhD
- Phone Number: 2034868066
- Email: yomna.yacout@alexu.edu.eg
-
Contact:
- Eiman S Marzouk, MSc, PhD
- Phone Number: 2034868066
- Email: eiman.marzouk@alexu.edu.eg
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Principal Investigator:
- Yasmine M Mahmoud, MSc
-
Principal Investigator:
- Mahmoud A Amin, BDS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.)
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Corticopuncture-facilitated MARPE
Patients will be treated using Maxillary Skeletal Expander (MSE II, Biomaterials Korea Inc., Seoul, Korea) with corticopunctures .along the mid-palatal suture
|
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
|
ACTIVE_COMPARATOR: Conventional MARPE
Patients will be treated using Maxillary Skeletal Expander (MSE II, Biomaterials Korea Inc., Seoul, Korea) without corticopunctures.
|
Maxillary Skeletal Expander (MSE II, Biomaterials Korea Inc., Seoul, Korea) used to correct the maxillary transverse deficiency
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
At baseline and an average of 6 months after the initial activation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
|
At baseline and an average of 6 months after the initial activation
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yomna M Yacout, MSc, PhD, Alexandria University
- Study Chair: Eiman S Marzouk, MSc, PhD, Alexandria University
Publications and helpful links
General Publications
- GREENE 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.
- 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.
- Bud 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.
- 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 Nov;144(5):759-69. doi: 10.1016/j.ajodo.2013.04.022.
- Cantarella 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0489-8/2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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