Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2026-01-03 @ 1:17 AM
Study NCT ID:
NCT02179593
Status:
UNKNOWN
Last Update Posted:
2016-03-16
First Post:
2014-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of SARPE With 3 and 2-Segment Technique: A Randomized Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063173', 'term': 'Retrognathia'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-03-14', 'studyFirstSubmitDate': '2014-06-29', 'studyFirstSubmitQcDate': '2014-06-30', 'lastUpdatePostDateStruct': {'date': '2016-03-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Life', 'timeFrame': 'An average of 2 weeks after expansion.', 'description': 'The primary outcome chosen in this study is Quality of Life assessed through the Orthognathic Quality of Life Questionaire (OQLQ) and Oral Health Impact Profile (OHIP-49) currently available in Portuguese language and validated for scientific studies.'}], 'secondaryOutcomes': [{'measure': 'Maxillary symmetry', 'timeFrame': 'pre-operative and an average of 2 weeks at the end of maxillary expansion.', 'description': 'The maxillary symmetry will be assessed by analyzing before and after 3D imaging obtained from computed tomography data , superimposed using the Geomagic Qualify software.'}, {'measure': 'Stability of dental and osseous structures', 'timeFrame': 'pre-operative, an average of 2 weeks at the end of the expansion, 4 months, 1 and 2 years after maxillary expansion.', 'description': 'The stability of dental and osseous structures will be analyzed using computer-aided 3D analysis of data obtained through the scanning of dental casts using Bicam 3D scanner (Scaierman - Italy).'}, {'measure': 'Nasal and paranasal topographic changes', 'timeFrame': 'pre-operative,an average of 2 weeks at the end of the expansion, 4 and 12 months after maxillary expansion.', 'description': 'The nasal and paranasal topographic changes will be captured using laser scanner device.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Maxillary expansion', 'Orthognathic surgery', 'Symmetry', 'Palatal expansion technique', 'Maxilla abnormality'], 'conditions': ['Maxillary Hypoplasia']}, 'descriptionModule': {'briefSummary': 'A few studies state that 3-segment SARPE has the following advantages: a) higher level of expansion symmetry; b) higher level of stability of the expansion achieved; and c) faster bone healing. The investigators hypothesize that 2-segment SARPE is as effective as 3-segment SARPE concerning treatment and/or quality of life in daily practice.', 'detailedDescription': '32 healthy, literate adult patients (male and female) with 7-millimeter transverse maxilla deficiency bilaterally distributed will participate in this study.\n\nThe participants will be assigned randomizable in equal number to undergo either 3-segment or 2-segment SARPE.\n\nIndividuals that a) have undergone maxilla surgery previously; b) have craniofacial anomaly;and c) have dental crowding will not be enrolled.\n\nAll participants will be assessed before and after surgery for sensitivity to pressure and temperature in the innervated structures linked to the maxilla, as well as for quality of life using OHIP-49 and B-OQLQ assessment tools.\n\nThe expansion of maxilla will be assessed by superimposing tomographic images before and after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being healthy and literate\n* Having 7-millimeter transverse maxilla deficiency bilaterally distributed.\n\nExclusion Criteria:\n\n* Having undergone maxilla surgery previously\n* Having craniofacial anomaly\n* Having excessive dental crowding.'}, 'identificationModule': {'nctId': 'NCT02179593', 'acronym': '3S/2S_SARPE', 'briefTitle': 'Effectiveness of SARPE With 3 and 2-Segment Technique: A Randomized Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of São Paulo'}, 'officialTitle': 'Effectiveness of Surgically Assisted Rapid Palatal Expansion (SARPE) With 3 and 2-Segment Technique: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '464.869'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '2-Segment SARPE', 'description': 'Maxilla expansion using one sagittal section of the maxilla.', 'interventionNames': ['Other: 2-Segment SARPE']}, {'type': 'OTHER', 'label': '3-Segment SARPE', 'description': 'Maxilla Expansion using two parasagittal section of the maxilla.', 'interventionNames': ['Other: 3-Segment SARPE']}], 'interventions': [{'name': '2-Segment SARPE', 'type': 'OTHER', 'otherNames': ['Surgically Assisted Rapid Maxillary Expansion (SARME)', 'Surgically Assisted Rapid Palatal Expansion (SARPE)'], 'description': 'Le Fort I osteotomy with oppening of the median palatal suture and SARPE.', 'armGroupLabels': ['2-Segment SARPE']}, {'name': '3-Segment SARPE', 'type': 'OTHER', 'otherNames': ['Surgically Assisted Rapid Palatal Expansion (SARPE)', 'Surgically Assisted Rapid MaxillaryExpansion (SARME)'], 'description': 'Le Fort I osteotomy with two parallel osteotomies symetrically positioned with reference to the median palatal suture and SARPE.', 'armGroupLabels': ['3-Segment SARPE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04024002', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Federal University of Sao Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Max D Pereira, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of São Paulo'}, {'name': 'Gabriela PR Prado, MS', 'role': 'STUDY_CHAIR', 'affiliation': 'Federal University of São Paulo'}, {'name': 'Fabianne MG Furtado, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Federal University of São Paulo'}, {'name': 'Lydia M Ferreira, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Federal University of São Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of São Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Max Domingues Pereira', 'investigatorAffiliation': 'Federal University of São Paulo'}}}}