Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-26 @ 12:27 AM
Study NCT ID:
NCT05543460
Status:
COMPLETED
Last Update Posted:
2025-10-02
First Post:
2022-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Miniscrew-assisted Rapid Palatal Expansion With and Without Corticopuncture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063173', 'term': 'Retrognathia'}, {'id': 'D008310', 'term': 'Malocclusion'}], 'ancestors': [{'id': 'D007569', 'term': 'Jaw Abnormalities'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D019767', 'term': 'Maxillofacial Abnormalities'}, {'id': 'D019465', 'term': 'Craniofacial Abnormalities'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D008336', 'term': 'Mandibular Diseases'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D014076', 'term': 'Tooth Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2022-09-14', 'studyFirstSubmitQcDate': '2022-09-14', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Transverse skeletal changes from baseline to an average of 6 months after the initial activation, measured using cone beam computed tomography (CBCT)', 'timeFrame': 'At baseline and an average of 6 months after the initial activation', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Dento-alveolar inclination changes from baseline to an average of 6 months after the initial activation, measured using CBCT', 'timeFrame': 'At baseline and an average of 6 months after the initial activation', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rapid palatal expansion', 'Maxillary Skeletal Expander', 'Corticopunctures', 'MARPE'], 'conditions': ['Palatal Expansion Technique', 'Posterior Crossbite', 'Maxillary Hypoplasia', 'Malocclusion']}, 'referencesModule': {'references': [{'pmid': '6305058', 'type': 'BACKGROUND', 'citation': 'Zeuke W, Heidrich R. [Late paralysis of the peripheral nerves from the neurologic viewpoint]. Zentralbl Neurochir. 1983;44(1):53-5. German.'}, {'pmid': '33802266', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '24182592', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '29090368', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '14076341', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': '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.\n\nThe 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.\n\nA 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 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.)\n2. 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.)\n3. 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.)\n\nExclusion Criteria:\n\n1. History of previous orthodontic or orthopedic treatment.\n2. History of facial trauma or surgery.\n3. Patients with congenital craniofacial malformations or diagnosed syndromes.\n4. Medical history that prohibits the surgical intervention.'}, 'identificationModule': {'nctId': 'NCT05543460', 'briefTitle': 'Miniscrew-assisted Rapid Palatal Expansion With and Without Corticopuncture', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Assessment of Miniscrew-assisted Rapid Palatal Expansion With and Without Corticopuncture in Adults: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '0489-8/2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Corticopuncture-facilitated MARPE', 'description': 'Patients will be treated using Maxillary Skeletal Expander (MSE II, Biomaterials Korea Inc., Seoul, Korea) with corticopunctures .along the mid-palatal suture', 'interventionNames': ['Procedure: MARPE with Corticopunctures']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional MARPE', 'description': 'Patients will be treated using Maxillary Skeletal Expander (MSE II, Biomaterials Korea Inc., Seoul, Korea) without corticopunctures.', 'interventionNames': ['Device: MARPE']}], 'interventions': [{'name': 'MARPE with Corticopunctures', 'type': 'PROCEDURE', 'description': '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', 'armGroupLabels': ['Corticopuncture-facilitated MARPE']}, {'name': 'MARPE', 'type': 'DEVICE', 'description': 'Maxillary Skeletal Expander (MSE II, Biomaterials Korea Inc., Seoul, Korea) used to correct the maxillary transverse deficiency', 'armGroupLabels': ['Conventional MARPE']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Faculty of Dentistry, Alexandria University', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'overallOfficials': [{'name': 'Yomna M Yacout, MSc, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alexandria University'}, {'name': 'Eiman S Marzouk, MSc, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Alexandria University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Yomna Mohamed Mohamed Yacout', 'investigatorAffiliation': 'Alexandria University'}}}}