Ignite Creation Date:
2025-12-24 @ 1:35 PM
Ignite Modification Date:
2025-12-24 @ 1:35 PM
Study NCT ID:
NCT04970095
Status:
UNKNOWN
Last Update Posted:
2021-07-27
First Post:
2021-07-16
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Alt-RAMEC Expansion and Protraction by EDO in Cleft Lip and Palate Patient
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002971', 'term': 'Cleft Lip'}], 'ancestors': [{'id': 'D008047', 'term': 'Lip Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009056', 'term': 'Mouth Abnormalities'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2023-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-20', 'studyFirstSubmitDate': '2021-07-16', 'studyFirstSubmitQcDate': '2021-07-16', 'lastUpdatePostDateStruct': {'date': '2021-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in 3D dimension of skull after and before expansion', 'timeFrame': 'six month', 'description': 'Full skull Cone Beam Computerized Tomography'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Alt-RAMEC', 'expansion', 'cleft lip and palate patient', 'cone beam computed tomography (CBCT)', 'protraction', 'facemask', 'MAXILLARY EXPANDER WITH DIFFERENTIAL OPENING (EDO)'], 'conditions': ['Cleft Lip and Palate']}, 'referencesModule': {'references': [{'pmid': '27692413', 'type': 'BACKGROUND', 'citation': 'Garib D, Lauris RC, Calil LR, Alves AC, Janson G, De Almeida AM, Cevidanes LH, Lauris JR. Dentoskeletal outcomes of a rapid maxillary expander with differential opening in patients with bilateral cleft lip and palate: A prospective clinical trial. Am J Orthod Dentofacial Orthop. 2016 Oct;150(4):564-574. doi: 10.1016/j.ajodo.2016.05.006.'}, {'pmid': '33754882', 'type': 'BACKGROUND', 'citation': 'Singh S, Batra P, Raghavan S, Sharma K, Srivastava A. Evaluation of Alt-RAMEC With Facemask in Patients With Unilateral Cleft lip and Palate (UCLP) Using Cone Beam Computed Tomography (CBCT) and Finite Element Modeling-A Clinical Prospective Study. Cleft Palate Craniofac J. 2022 Feb;59(2):166-176. doi: 10.1177/10556656211000968. Epub 2021 Mar 23.'}], 'seeAlsoLinks': [{'url': 'https://www.greatlakesdentaltech.com/maxillary-expander-with-differential-opening-edo.html', 'label': 'Maxillary Expander with Differential Opening (EDO)'}]}, 'descriptionModule': {'briefSummary': 'Evaluate the treatment outcome of Alternate Rapid Maxillary Expansion and Constriction Alt-RAMEC protocol on patients with cleft lip and palate, using a differential opening expander and face mask which will be measured and recorded by cone beam computed tomography (CBCT).', 'detailedDescription': 'Cleft lip and palate are among the most common deformities in children.Clefts patient are usually having orofacial problems as missing or unerupted permanent teeth, alveolar bone defect, speech difficulty . Patients with cleft lip and palate (CLP) commonly have maxillary arch constriction (maxillary hypoplasia) and Class III malocclusions due to deficient of maxillary growth The upper jaw of patients with cleft palate will be expanded by Maxillary Expander with Differential Opening (EDO) with alternate rapid maxillary expansion and constriction (Alt-RAMEC) , which is opened by opening the expansion device by 1 mm per day for a week, then closing the device at a rate of 1 mm per day in the second week and so on alternately for 7 consecutive weeks after the completion of the expansion, the facemask device will be used to protraction of maxilla the measurement and difference before and after treatment will be assessment by cone beam computed tomography (CBCT). .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of both sexes.\n* Cleft lip and palate patients.\n* All patient age ranges from 8 to 12 years.\n* All the cases showed maxillary arch constriction and deficiently\n* All patients had maxillary permanent first molars.\n* Primary lip adhesion and palatal closure.\n\nExclusion Criteria:\n\n* Patients had received any surgical assisted expansion or maxillary protraction or fixed orthodontics before.\n\n 2\\. Maxillary dentition unsuitable to bond the expander (less than two dental unit bedside first permanent molar) .\n\n 3\\. Absent maxillary permanent first molars. 4. Uncooperative patients/parents'}, 'identificationModule': {'nctId': 'NCT04970095', 'briefTitle': 'Alt-RAMEC Expansion and Protraction by EDO in Cleft Lip and Palate Patient', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Faculty of Dental Medicine for Girls'}, 'officialTitle': 'Evaluation of Alt-RAMEC by EDO With Facemask in Patients With Cleft Lip and Palate (UCLP) Using Cone Beam Computed Tomography (CBCT)', 'orgStudyIdInfo': {'id': 'ORTHO-109-2-F'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cleft lip and palate patient', 'description': 'Clefts patient with transverse maxillary constriction and anteroposterior deficiency', 'interventionNames': ['Device: Maxillary Expander with Differential Opening (EDO)', 'Device: Petit Face Mask']}], 'interventions': [{'name': 'Maxillary Expander with Differential Opening (EDO)', 'type': 'DEVICE', 'description': 'The EDO is designed with two expansion screws positioned transversely. When more expansion is required between the canines, the anterior screw can be further activated. Both expansion screws can be activated to open in a parallel configuration. Pivoting corner screws allow for different amounts of expansion without significant risk of binding during activation.', 'armGroupLabels': ['cleft lip and palate patient']}, {'name': 'Petit Face Mask', 'type': 'DEVICE', 'description': 'The face mask is anatomical, multi-adjustable, lightweight and an ideal therapeutic alternative for the correction of Class III malocclusion.\n\nconsist of forehead cap chin cap cross bar', 'armGroupLabels': ['cleft lip and palate patient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0000', 'city': 'Cairo', 'state': 'Nasr City', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'mohsena a. abdelrazq, phd', 'role': 'CONTACT', 'email': 'MohsenaAhmad.el.8.383@azhar.edu.eg', 'phone': '+201005839539'}], 'facility': 'faculty of dental medicine for Girls, Al- Azhar University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'sarah s. kahlil, master', 'role': 'CONTACT', 'email': 'sarahabdelaal.p5821@azhar.edu.eg', 'phone': '+201128899261'}, {'name': 'mohamed m. elabd, master', 'role': 'CONTACT', 'email': 'sarahlala83@gmail.com', 'phone': '+201064244061'}], 'overallOfficials': [{'name': 'maha m. mohamed, phd', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lecturer of Orthodontics Department Faculty of Dental Medicine for Girls Al-Azhar University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Evaluation of EDO ,Alt-RAMEC With Facemask in Patients With Cleft lip and Palate (UCLP) Using Cone Beam Computed Tomography (CBCT)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Faculty of Dental Medicine for Girls', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'sarah salah khalil Abdelaal', 'investigatorAffiliation': 'Faculty of Dental Medicine for Girls'}}}}